Wednesday, April 23, 2014

Anti-HIV Molecules: The Key Role of One Everyday Material

This post was authored by @MikeMadarasz of the Institute for International Research

“Injection molding high temperature resistant plastics provide part makers with design flexibility, high production rates, lower labor costs, and less or no finishing of molded parts.” 

Believe it or not, some of the manufacturing advantages of polymers (above) could be crucial to a key biologic development.  Polymers, a synthetic material in everything from styrofoam to credit cards, may actually be part of a solution to one day block HIV infection.  Thanks to new techniques in synthetic chemistry, scientists are now exploring ways to use polymers in biological settings. 

Dan Mitchell, a researcher at the University of Warwick, UK, is one of these scientists.  “Over the last ten or fifteen years, the types of chemical reactions used to synthesize polymers have elaborated, so you can now develop polymers of a highly defined length and size” explained Mitchell in a recent BioRadiations article.  Mitchell and his colleagues are specifically focused on the DC-SIGN protein, which play a critical role in the onset of an HIV infection, and how polymers might interact with it.  In the initial stages of HIV, the virus uses DC-SIGN receptors as a vehicle to travel to the lymph nodes.

Manipulating polymers in a way that would allow them to bind to DC-SIGN proteins could ultimately inhibit HIV infections.  In a recent paper, Mitchell and his colleagues described a high level of success in controlling these polymers.  Explains Mitchell, “Unlike mixing lots of different polymer lengths together as you would to make a composite like nylon fabric, we made polymers that were sequence-controlled at the molecular level… We had a range of molecules with different types of carbohydrate molecules at distinct points along the polymer backbone we wanted to see which ones bound to DC-SIGN better or worse, and did that correlate with the existence of sugars at specific points in those polymers?”

To answer this question, Mitchell and his team set up a series of competition assays—analyzing them with Bio-Rad’s ProteOn™ XPR36 protein interaction array systemThe results were encouraging.  Mitchell found that the polymers did indeed prevent binding on the DC-SIGN protein. 

So what’s next?  “The next step is to use these polymers in experiments with very high quality cells or even tissues,” Mitchell says. “We need to get cells from human beings, incubate them with the polymers, and study their responses. We don’t have that set up yet.”  With more research, future studies with more complex HIV models could be on the horizon. 

You can check out the full article from BioRadiations here.

We’ll have more on the latest in protein research at the Next Generation Protein Therapeutics Summit as well as IBC’s inaugural Protein Aggregation, Stability and Solubility event.
June 4-6 | San Francisco, CA

Register for Next Generation Protein Therapeutics Summit and save 20%. Use code NGP14BLOG

Register for Protein Aggregation, Stability and Solubility event and save 20%. Use code D14200BLOG


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Tuesday, April 22, 2014

Antibody Engineering & Therapeutics Call For Speakers

The deadline for speaker abstract submissions for the Antibody Engineering & Therapeutics Event is Friday, April 25, 2014. To submit a proposal, you will be asked to select the conference topic you are interested in, provide a 100-150 word summary of your proposed talk and provide your full contact details.

We are looking for presentations in the following topic areas:
  • • Going Deep: Finding Good Antibody Targets beyond the Low Hanging Fruit - Antibodies against Difficult Targets for Therapeutics
  • • Going Broad: High Quality Research Antibodies against the Proteome: TFs and other Binders
  • • Antibody Effector Functions
  • • Immunocytokine Engineering
  • • Antibody-based Therapeutics for Diabesity: The Link between Diabetes and Obesity
  • • Antibody Therapeutics for Non-Cancer Indications (Alzheimer’s, Infectious Disease, Autoimmune, Pediatric and other Diseases. MOA Studies and Biological Understanding)
  • • Next Generation Sequencing: Human Antibody Repertoires and Other Applications
  • • Immune Checkpoints: Target Discovery and New Agent Design for Antibody Therapy
  • • Immune Checkpoints: Preclinical and Clinical Development Case Studies
  • • Combination Antibodies and mAb Fusions (Antibody Mixtures, Fusions w/Cytokines or Other Biomolecules, ADCs, Combined Binding Domains to Create New Modalities)
  • • Targeted Immunomodulation in Cancer: Antibody-conjugated Cytokines and Adjuvants
  • • Antibody Biophysical Characterization/Preclinical Characterization (What to assess, How to assess and Why?)
  • • Research-Based Process Development of Antibodies (Discovery stage evaluations of formulation, aggregation, structure/stability, antibody production and purification )
  • • Preclinical and Clinical Case Studies of Antibody-based Therapeutics (Including PK/ADME data, discussion of clinical challenges, failure analysis)
  • • Antibody Targeting and Alternative Delivery (Going beyond tumor-targeting: Targeting to specific cells, tissues and organs)
  • • Antibody Modeling and Computational Design/Knowledge-based Design of Antibodies
  • • Preclinical and Clinical Case Studies: Emerging Targets, New Approaches
  • • Why is Choosing Targets for Bispecific Antibodies so Difficult?
Are you interested in exhibiting?  Find out how.

Antibody Engineering & Therapeutics will take place December 7-11, 2014 in Huntington Beach, California.  Register now for the lowest rates of the year.  You can also sign up for the latest updates on this year's program.


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Friday, April 18, 2014

BioProcess International Awards: Individual Achievement

The 2014 BioProcess International Awards celebrate and recognize the outstanding people, organizations and technologies that have significantly changed, impacted, and advanced the efficiency of biotherapeutic development and manufacturing process ultimately allowing the industry to deliver better, more effective treatments to a global patient base.  We're accepting nominations through June 27, 2014.   In the weeks leading up to the nomination deadline, we'll be spotlighting many of the award categories here. Visit the webpage to find out more.

Today, we spotlight the award for:

Individual Achievement

Some significant achievements receive high-profile acknowledgment, whereas others have quietly led to improvements in research, development, cell-line engineering, downstream processing, analytical methods, regulatory preparations, and commercial manufacturing — somewhat “behind the scenes.” Yet the history of the modern biopharmaceutical industry is one of human inventiveness and entrepreneurial risk-taking. All personal achievements, large and small, and from a range of corporate departments, functions, and professional disciplines, contribute to the success of our industry. Nominate someone you know whose work this past 18 months has made a significant difference in how you do your work and/or how your process and/or business operates. Can you point to how this achievement may improve process efficiencies and ease the route to commercialization?

The BioProcess International Awards will be handed out this October at the BioProcess International event in Boston.  If you have any questions, feel free to reach out to Jennifer Pereira.


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Thursday, April 17, 2014

13 Steps To Successful Potency Assays

Today, we feature an article from BioProcess International magazine co-authored by Biological Assays event chair. Laureen E. Little, Ph.D., Principal Consultant, Quality Services.

  1. 1. Acquire as broad and in-depth as possible an understanding of the biological and other properties and actions of the cellular therapy product(s) for which you wish to develop potency methods. You should collect sufficient product characterization data (molecular, biochemical, immunologic, phenotypic, hysical, and biological properties) throughout preclinical and clinical development to inform and refine your approach to measuring potency.
  2. 2. Acquire broad and in-depth knowledge of the process by which your cellular product is manufactured.
  3. 3. Familiarize yourself with the way in which the product is administered and the events that follow administration.
  4. 4. Start designing and developing two (or possibly more) potency assays early — as early as during preclinical development is desirable. Developing at least two different methods increases your chances that one of them will be suitable for both your company and the regulators.
  5. 5. Realize that biological potency assay design and development for GMP use requires considerable, specialized, and varied knowledge and experience. If you are not already an expert, either become one (for suggestions, see box, Gaining Expertise in Biological Potency Method Development”), find and apprentice yourself to one in your organization, hire one, or engage the services of an expert consultant. Be sure to confirm that any prospective employee or consultant has specific knowledge and experience in developing and validating biological potency assays.
  6. 6. Initiate and maintain a discussion with your CBER Reviewers so that you have agency feedback to assist in your development decision making.
  7. 7. Familiarize yourself with all relevant regulations and guidance and get current and stay current with the technical literature.
  8. 8. Thoroughly characterize all rare and other reagents, reference materials, standards, and controls.
  9. 9. Thoroughly characterize and qualify your potency assay(s).
  10. 10. Give regular technical presentations to gain input from your colleagues.
  11. 11. Be diligent in creating a formal Method Development Plan and in keeping a Development Report and refer to them often.
  12. 12. Determine the robustness of, and validate your potency method(s) before your end of phase 2/pre-pivotal trial meeting with FDA
  13. 13. If you outsource development of your potency assay(s), always have a knowledgeable and experienced employee or consultant, whose services your company has engaged, guide and manage the product development.


Would you like to meet with Dr. Little?  Dr. Little will be hosting the workshop A Practical Guide to the Development of Assays for Evaluation of Biologics and Biotherapeutics – a Systematic Approach to Supporting Product Development in the Regulatory Environment on Monday, May 5 in Berkeley, California at Biological Assays.  For more information on her workshop and the rest of the event, which takes place May 5-7, download the agenda. As a reader of this blog, you are eligible save 20% off the standard rate when you register to join us and mention code B14177JT.


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Wednesday, April 16, 2014

Single-Use Tech: Four Facts to Impress Your Colleagues

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

The verdict is on the environmental effects of single-use technology in comparison to stainless steel.  We now have a good grasp on this topic and all signs point to single-use systems impacting the surrounding environment to a much lesser extent than re-useable technologies.  BioProcess International recently took a close look at some of the sustainability issues associated with single-use processes.  Here are four facts you can use to impress your colleagues the next time this conversation comes up:

·       -  A single-use technology facility uses about 50% less energy than one based in stainless steel.  This is largely due to the amount of energy required to heat processed water in sterilizing reusable equipment. 

·      -  Some studies suggest that adopting a single-use system results in a reduction of about 85% of both water usage and waste generation from that of stainless steel.

·      -  One study shows that energy demand and global warming potential with single-use systems is 30-35% lower than stainless steel systems over the full manufacturing life of the facility.

·      -  As far the different types of environmental impacts associated with single-use, 22 different categories have been identified. 

How can single-use technology become improve on its environmental impact? One idea is to reduce the impact of disposable plastic containers used in these processes. The most common solution there appears to be finding ways to repurpose and recycle that plastic rather than letting it amount to waste.

Any other ideas on improving sustainability?

You can check out the full article from BPI here.

We’ve got much more on single-use systems. Check out Single-UseApplications for Biopharmaceutical Manufacturing. June 9-10, Boston MA

Register now and SAVE 20%. Use code XB14187BLOG

Follow us on Twitter @FutureBioPharma


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BDP WEEK 2014: Antibody Drug Conjugates

There was a heavy concentration of talks on antibody drug conjugates the last two days of BDP Week, so much so that the speakers soon started to either refer to the previous talks when relevant or promote an upcoming talk that was going to provide further information.

Talks covered ADC architecture, especially new linker chemistry and site-specific conjugation, as well as therapeutic index, stability, next generation cytotoxins and mechanism of action, heterogeneity, aggregation, analytical characterization, process development and critical quality attributes especially with respect to formulation.

The ADC lexicon used by Hans-Peter Gerber, Executive Director, Bioconjugates R&D, at Pfizer Oncology Research Unit East, was “empowered antibodies” and “therapeutic index”. The empowerment bestowed upon the antibody was its payload, or warhead as some would refer to it in other talks, which it delivered to the targeted cell with its surface displayed antigen. The therapeutic index was the score card, focus or indicator for improvement and as such was the key driver to innovation; the index being the dosage ratio of maximum tolerability to minimum efficacy. Some of the innovation at Pfizer presented by Gerber included methods for site-specific conjugation of the payload to the antibody which the audience would soon realize was going to be a common theme in talks to come. Site-specific conjugation was highlighted for its facilitation of CMC and regulatory filings presumably because it resulted in the advancement to a second generation ADC that was less heterogeneous. Gerber also talked about innovative empowerment and improved therapeutic index by listing a couple strategies to target cancer such as a focus on tumor initiating cells and payloads with cell cycle dependent and independent mechanisms of action.

Sutro Biopharma gave three presentations, those being by Senior Directors Dawn Benson of Quality and Heidi Hoffmann of Manufacturing, and Chief Scientific Officer Trevor Hallam. The protein synthesis platform developed and commercialized by Sutro is a “disruptive” and “game changing” technology in the biopharmaceutical industry, which is a cell-free system known as Xpress CF based on the E. coli-based open cell-free synthesis technology pioneered by Professor James Swartz at Stanford University. Xtract DF is derived from Xpress CF and was described as the protein synthesis “secret sauce” behind the unique platform. The open system offers a “large parameter space” for optimization of the first stage of the process life cycle in a high throughput format which has been proven to be linearly scalable from the 250 L to 100 L scale as far as volumetric activity of active target protein in g/L yield. Sutro gets frequent flier mileage out of the marketing statement, “gene sequence to drug substance in days”, used to describe the speed of their technology. Site-specific conjugation practically anywhere on the antibody is achieved by incorporation of an unnatural amino acid into the protein sequence via an amber codon and a tRNA and aminoacyl-tRNA synthetase pair for linkage to the payload via click chemistry. The platform essentially gives Sutro combinatorial synthesis capability to screen for an optimal ADC architecture for therapy with any antibody at any position with variable linkers and payloads. In fact, game changer status is taken to a new height in oncology therapy since the ADC architecture optimization capability includes the ability to create next generation bi-specific and multi-specific antibodies such that one ADC can include more than one type of payload. This was explained by describing the initial and separate translation of light chain with incorporation of a site-specifically located unnatural amino acid followed by heavy chain with incorporation of a different orthogonally reactive site-specifically located unnatural amino acid.

Tim Lowinger, CSO of Mersana Therapeutics, presented on the Fleximer platform, which is built on a biodegradable polyacetal polymer which can be conjugated to the antibody via either cysteine or lysine residues. The Fleximer platform is advantageous because it acts as a solubilization vehicle for hydrophobic drugs, is enabling for low potency drugs as well as low normal expression tumor surface antigen due to its high payload capacity whilst still having good pharmacokinetic properties, has a broad array of linker chemistries to accommodate a variety of payloads, and has a stabilizing effect as an anti-aggregation agent. Fleximer has especially found utility in conjugation to antibody fragments since its polymer synthesis can be engineered to optimize stability and preserve critical quality attributes of the ADC by matching its size relative to the antibody fragment.

Another company in the line-up of presentations was ImmunoGen, who gave several talks, including by Michael Miller, Principle Scientist in Chemistry, and Rajeeva Singh, Lead Scientist in ADC Technology Development, plus chaired more than one topic track session. ImmunoGen has broadened the therapeutic spectrum of ADC’s by expanding the mechanism of action beyond inhibition of tubulin polymerization to include DNA-acting agents. They reported on advances in the development of their IGN payload platform which contain indolino benzodiazepine dimers responsible for sequence selective DNA alkylation and cross-linking adduct formation with high potency as determined by in vitro IC50 values in the picomolar range. The therapeutic index was improved by making certain modifications to limit the mechanism of action to either DNA alkylating or cross-linking. ImmunoGen also generated results which were an indication that linker selection in ADC design played a role in the therapeutic index of the IGN family of agents. ImmunoGen has also observed that linker development and selection can play a role in combating the mechanism of tumor cell multidrug resistance apparently by increasing the residence time of the ADC and payload inside the cell versus being exported back outside. Other desired features of ImmunoGen’s IGN-based ADC platform include good aqueous solubility and stability. ImmunoGen also reported on advances in linker design which expanded the therapeutic opportunity of their maytansinoid ADC (MAY-ADC or AMC) platform. The working hypothesis derived from results thus far is that their CX-AMC platform (CX indicates a new tri-glycyl peptide segment added-on to their cleavable disulfide linker) enables target cell-activated killing of bystander cells in a heterogeneous tumor cell population (i.e., antigen-positive and antigen-negative) via enhanced linker processing resulting in formation of a potent CX-MAY catabolite with improved efficiency in lysosomal processing with respect to extracellular efflux.

In summary, it became ever increasingly evident that ADC architectural design and screening for optimized therapeutic index must involve an integrated approach, or perhaps more aptly described as a combinatorial approach, involving all aspects of each component; in other words, a combinatorial approach should include; 1) antigen selection and management of DAR, location and heterogeneity by site-specific conjugation such as by engineered cysteines or site-specific incorporation of unnatural amino acids for the antibody, 2) cleavable and noncleavable linkage chemistry coupled with modifications for enhanced intracellular processing, for example with respect to multidrug resistance for the linker format, and 3) multiple mechanisms of action for the payload whether it be tubulin-acting, DNA-acting, or inhibition of RNA polymerase. Manufacturing was also a topic of some talks; in fact, the last speaker of the conference, Klaus Kaiser, Head of Downstream Processing and Analytical at Bayer Pharma AG, left the audience with some thoughts about the ADC community’s need for a one-stop shop CMO and the next major improvement or breakthrough in ADC’s possibly being continuous manufacturing involving plug-flow or continuous stirred tank reactors. Ironically, a market research report had been released earlier in the conference that was titled, Antibody Drug Conjugates: Contract Manufacturing Market 2014 – 2024.

Today's post comes from Gregory T Mrachko a Protein Chemist and Enzymologist. He specializes in protein purification, enzymology, high throughput assay/screen conceptualization/development/implementation, analytical biochemistry, biocatalysis, liquid column chromatography, and protein analytics. He is a guest blogger at this year's Biopharmaceutical Development and Production Week and can be reached at gmrachko@msn.com.


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Tuesday, April 15, 2014

BDP Week 2014: Biosimilars

Biosimilars had a brief spotlight at BDP Week in two track sessions, Analytical Technologies for Biotherapeutic Development (ATBD) and as a featured presentation in Antibody Development and Production (ADP). The focus of the presentations in the ATBD track was on characterization and comparability of biosimilars while the focus in the ADP track was less on characterization and more on addressing the debate on biosimilarity.

Judy Chou, VP of R&D at Tanvex Biologics, divided her presentation into a discussion on the challenges, approaches, and analyses involved in establishing similarity of a biologic to the predecessor innovative drug product, or biosimilarity. To put the challenge in perspective, Chou made a comparison between gaining approval for a generic drug and gaining approval for a biosimilar. She described the complexity of the approval challenge by depicting a generic as a bicycle and a biosimilar as a jet airplane; though they are both transportation vehicles, a bicycle is not only smaller and lighter, but it has far less complexity with respect to its blueprint on the electrical, mechanical, and structural design of its operation. The approach to determining biosimilarity was likened by Chou to the story of the blind men and an elephant. This parable with origins in India is about how six blind men decide that they are going to take it upon themselves to describe and define an elephant, an animal which has stirred their curiosity based on other accounts. Each blind man analyzes the elephant by touch from a different angle or entry point, and as a result derives a different description of the animal. Chou equates the elephant to the biosimilar, and in her version of the parable she wants to setup the blind men for success by equipping them with tools to overcome their blindness. These tools are physicochemical methods of protein characterization and biological activity assays that are each validated or correlated by a secondary orthogonal method and that are all established early on as standard operating protocols.

Chou stressed the importance of gaining a complete understanding of the biological molecule with respect to hotspots of higher order structural variability and when in the process those hotspots are susceptible to undergoing change. She added that early establishment of standard operating protocols pertaining to process analytical technology for characterization is imperative to success. An emphasis was placed on the implementation of quality by design to guide the establishment of design space boundaries and critical process parameters, and definition of critical quality attributes of the biosimilar. Chou concluded by referring back to the blind men and the elephant, and stated that it is when guided by principles of quality and criticality, equipped with capability for “fingerprint analysis”, and results are integrated to arrive at a “totality of the evidence” that a determination can be made about comparability, similarity and interchangeability.

Steve Flatman, Head of Research and Technology and Biosimilars Development at Lonza Biologics, didn’t rely on analogies to proverbs or cartoon graphics such as bicycles, jets and elephants, but his presentation resonated with Chou’s emphasis on the utilization of fingerprint methods in determining comparability and biosimilarity in that he stated that the goal of the biosimilar applicant is essentially “to manufacture a copy”. The approach to the development of a process to, as stated by Flatman, “ensure manufacturability”, relies on an “excruciatingly thorough literature review” of the molecule, tight controls, and incorporation of quality by design principles. The key success factor to making such a copy, or biosimilar, is testing strategy, which Flatman advised is guided by a clear understanding of requirements and compliance as put forth by the FDA in guidance documents, as well as in market intelligence forecasting. Product assessment should take place at “relevant stages” of the process, such as where the biosimilar is susceptible to losing comparability and biosimilarity, and rely on methods that are rated highly in specificity and sensitivity so that analytical results and differences to the reference product can be constructively evaluated with respect to “meaningfulness”. Some characterizations paramount to comparability and biosimilarity referred to by Flatman included isoform profiles and assessment of heterogeneity by orthogonal methods.

Basant Sharma, VP of API Large Molecule at Janssen R&D, started off giving a similar talk as Chou and Flatman, but then veered onto a different course. He started by saying that “the process defines the product”, and that the process includes production, purification, formulation, and handling and storage. He used epoetin as an example product. He depicted the structure of epoetin and noted that it is a mixture of isoforms in solution and that this is an important aspect when asking, “how similar is a biosimilar”, because a major concern of the FDA is immunogenicity as a function of protein structure. At this point Sharma veered onto a different course by introducing the “4 P’s” that factor into the scientific debate on acceptance of biosimilars.

P-1 is the policy maker who struggles with clearing the hurdle of interchangeability. P-2 is the physician who takes the stance of the residents of Minnesota, which is “show me” interchangeability, for example by conducting head-to-head trials. P-3 is the payor, or health insurance industry, whose focus is on discount prices and pharmacovigilance. Finally, P-4 is the patient who wants better than “marginal benefits”.

In summary, the major common themes amongst the three presentations were utilization of state of the art analytical capability, implementation of a thorough and orthogonal testing strategy especially regarding structure, integration of results to arrive at a “totality of evidence”, and being knowledgeable about the molecule and process in order to ensure manufacturability by applying quality by design and defining critical quality attributes and process parameters.

Today's post comes from Gregory T Mrachko a Protein Chemist and Enzymologist. He specializes in protein purification, enzymology, high throughput assay/screen conceptualization/development/implementation, analytical biochemistry, biocatalysis, liquid column chromatography, and protein analytics. He is a guest blogger at this year's Biopharmaceutical Development and Production Week and can be reached at gmrachko@msn.com.


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Monday, April 14, 2014

Four Reasons "Smart Outsourcing" Biorepositories Can Work for You

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

We are at point where researchers from nearly every medical discipline have come to appreciate the importance of having a centralized biorepository and the technological framework to house the data associated with these samples.  Transitioning from a decentralized model of storing these samples to a more centralized method has proved to be difficult and has led many institutions to begin outsourcing this task.  Kristina Robson of BioStorage Technologies says outsourcing is a smart option for companies that don’t have the internal bandwidth or expertise to manage these assets.   “Outsourcing sample management with an experienced service-provider has both financial and operational benefits” explains Robson.    

The operational benefits of some of the sophisticated sample management systems are fairly obvious as these providers offer a high quality, consistent solution for handling samples.  On the financial side, Robson cited a number of drivers that make “smart outsourcing” approaches an attractive option:

Speed — It could take as long as a year to establish a biorepository that can adequately store physical specimens needed to maximize today’s clinical endeavors. Insourcing alleviates this difficulty, as appropriate infrastructure for data management and storage can be developed in a matter of months. 
Decreased Cost — Sample management “smart outsourcing” models reduce infrastructure cost, thereby decreasing the need for large operations teams to manage/map data, provide governance and build custom query application.
Scalability — Because large quantities of biological materials are generated during drug R&D, thousands of samples need to be properly stored and tracked throughout clinical trials and beyond. Through innovative outsourcing partnership models, companies gain the ability to move samples offsite seamlessly to add capacity.
Quality Assurance — By leveraging SOPs already developed and validated by an outsourced partner, risk of specimen degradation through handling and storage techniques can be mitigated. 

You can check out Kristina Robson’s article in its entirety here.

What can these data-rich biorepositories do for your research?  We have the answer.  Join our free webinar- 4/30, 2:00-3:00PM EST.
Register here. DISCOUNT CODE: XP1998BLOG

Need the latest biorepository research? Check out Biorepositories and Sample Management Conference.
September 8-10 | Boston, MA

Why wait? Register now.  DISCOUNT CODE: XP1998BLOG


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Tuesday, April 8, 2014

Three Visuals to Explain the Impact of Pharmacogenomic and Epigenetic Biomarkers in Oncology

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

In an effort to increase efficiency and streamline development of effective cancer therapies as well hold down costs associated with conducting clinical trials, drug developers have increased their investment in clinical biomarker research.  Specifically, there has been an increase in the use of pharmagenomic (PGX) biomarkers to either select or stratify patients.  Citeline recently published a white paper outlining some of the major impacts in oncology—some of which are explained in the charts below.

The increase in oncology trials selecting or stratifying by PGBX Biomarkers
The percentage of trials in this category has more than doubled since 2002


Breakdown of countries in PGX trials
The U.S. accounts for nearly 30% of these trials with Japan being the next closest at almost 15%.


Top sponsors using PGX biomarkers to select/stratify patients
The National Cancer Institute comes out as the top sponsor both in the relative     sense and in number of PGX trials.



To check out more from Citeline, download the white paper here.

You can hear more from top industry thought leaders. Check out the Biorepositories and Sample Management Conference
September 8-10, 2015 Boston, MA

Register hereDiscount code: XP1998BLOG

Free Webinar-Breadth and Depth: Oh, What a Data-Rich Biorepository Can Do for Your Research!
DATE: April 30, 2014, 2:00 PM - 3:00PM EST 
Register here
Discount Code: XP1998BLOG


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Monday, March 31, 2014

Cancer Treatment: The Critical Role of ADCs

Mike Madarasz, @MikeMadarasz

Cancer treatment has been revolutionized over the years and much of that progress can be attributed to antibody therapeutics.  However, not all antibodies are effective therapeutics.  They can instead be utilized in antibody drug conjugates (ADCs) to deliver potent cancer-fighting drugs.  Tremendous progress has been made in this field including steps to increase the therapeutic window.  There are, however, improvements that can still be made to increase the therapeutic qualities of these ADCs. 

Here, authors from Genentech published a review article in the mAbs journal and describe the different strategies used that are currently used in the creation of ADCs.  Additionally, they summarize the differences between methods and some of the crucial considerations in building next generation ADC therapeutics. 

Download the full report here

We’ve got more to share about the latest in bioconjugates.  Check out Bioconjugates: From Targets to Therapeutics to hear more from top thought leaders including the team at Genentech.  

June 4-6, San Francisco, CA. 
Register Here
Discount Code: D14199BLOG


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Friday, March 28, 2014

Free Webinar: Breadth and Depth: Oh, What a Data-Rich Biorepository Can Do for Your Research

Mike Madarasz, @MikeMadarasz

Advancements in technology are rapidly increasing the applications for banked biospecimens in research.  When combined with comprehensive data annotation and appropriate study design, biorepository specimens can create an effective research environment.  This approach may help to avoid the challenges of traditional, prospective studies and potentially reduce both timelines and cost.

In our upcoming webinar, Mahesh Krishnan, MD, MPH, MBA, FASN, Vice President, Clinical Innovation and Public Policy for DaVita Healthcare Partners (with moderation by Scott Sibbel, PhD, Associate Director of Epidemiology at DaVita Clinical Research) will delve into the following:
  • Overview of how researchers, clinicians, and drug and diagnostic developers can employ banked specimens with comprehensive data annotation to aid in research
  • Review of  the model requirements to consider, including evidence of utility, accompanying clinical data annotation, and robust procedures enabling clinical-trial quality
  • Common objections to this approach and will include an interactive Q and A session.
DATE: April 30, 2014, 2:00 PM - 3:00PM EST

Register Here
Discount Code: XP1998BLOG

Continue the conversation on Biorepository research with Dr. Krishnan and Dr. Sibbel at IIR's 2014 Biorepositoriesand Sample Management Conference. 
September 8-10 | Boston, MA

Why wait? Register now


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Thursday, March 27, 2014

BDP Week Day 2: Analytical Technologies for Biotherapeutic Development: Characterization and Measurement Strategies

At the half-way point of the IBC Life Sciences Biopharmaceutical Development and Production Week 2014 conference draws near at the close of Day 2 on March 25th, there remains the last event which is the Beach Party where attendees can unwind and network on the San Diego water front removed from the seminar rooms and exhibit hall. It’s also a chance where information and lessons learned can be further disseminated that were presented by over 80 speakers in five topic session tracks not to mention several two-day training courses and a handful of technology workshops. The session tracks have included Analytical Technologies for Biotherapeutic Development (ATBD), Process Validation and Continued Process Verification, and Antibody Development and Production.

One such presentation in the Analytical Technologies for Biotherapeutic Development session track was by Aston Liu of GlaxoSmithKline, whose talk was titled Localized Conformation Changes from Chemical Modifications and their Impact on the Development of mAb-Based Protein Therapeutics. Amongst the numerous possible chemical modifications that could occur to a mAb, Liu chose to focus on the impact of deamidation and oxidation of methionine on structural conformation. The structural changes to a mAb can be characterized by several analytical techniques. Liu constructed a simple X-Y plot of analytical resolution versus sample throughput to describe and compare the instrumental methods. The objective was to identify a method that had both high resolution and high throughput. NMR has high resolution, but it has low throughput. FT-IR has relatively high throughput, but it has relatively low resolution. The focus of Liu’s talk was on the application of HDX-MS, or hydrogen-deuterium exchange detected by mass spectroscopy, because it lied in the sweet spot of his graph as a technique that had both high resolution and high throughput. HDX can occur as a function of solvent accessibility of the moiety undergoing exchange, secondary structure or conformational dynamics. Deamidation or oxidation of methionine can have an impact on any one or all three of these properties and thus give rise to HDX or a difference in rate of HDX compared to the unmodified mAb. These changes in structure can lead to changes in the stability of the mAb or its propensity for aggregation which can give rise to detrimental effects on safety and efficacy as a biopharmaceutical. Certain amino acids or regions of the mAb can thus be identified as “hot spots” depending on the impact of undergoing chemical modification and thus can be the focus of genetic engineering with respect to optimization of leads. Liu fielded a couple questions from the audience with respect to the correlation of a change in activity with a change in HDX. Liu reported he has determined that a change in HDX correlates to a change in mAb binding activity.

The characterization of protein conformation as a critical quality attribute of biotherapeutics was also the topic of discussion in later presentations, for example given by Robert Karlsson of GE Healthcare Life Sciences in a technology workshop and John Philo of Alliance Protein Laboratories in an ATBD session track. Karlsson spoke in part on a very early stage technology called Epitope Characterizing Reagents which are probes for protein conformation whose utility was described as part of the characterization of changes in binding properties of a mAb upon being subject to forced stress such as extreme pH and oxidation. Philo presented on the application of sedimentation velocity analytical ultracentrifugation, SV-AUC, for example in the comparison or identification of conformational changes that may arise upon a change in the manufacturing process.

Today's post comes from Gregory T Mrachko a Protein Chemist and Enzymologist. He specializes in protein purification, enzymology, high throughput assay/screen conceptualization/development/implementation, analytical biochemistry, biocatalysis, liquid column chromatography, and protein analytics. He is a guest blogger at this year's Biopharmaceutical Development and Production Week and can be reached at gmrachko@msn.com.


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Tuesday, March 25, 2014

BDP Week: Lifecycle Management of Processes for the Production of Biopharmaceuticals for the Treatment of Rare Diseases

The IBC Life Science Biopharmaceutical Development and Production Week in San Diego conference kicked-off the week on Monday March 24th with Joanne Beck, Vice President of Process Development at Shire, featured as a Keynote Speaker. The title of her talk was, Lifecycle Management of Processes for the Production of Biopharmaceuticals for the Treatment of Rare Diseases. Biopharmaceutical production for rare diseases meant greater challenges in the area of life cycle management of those processes because it involved orphan drug designation by the FDA with which hand-in-hand came accelerated development. A critical approach at Shire in life cycle management is to balance risk and product quality and availability for each of the one in 10
patients affected by one of the 7000 rare diseases of whom 50% are pediatric. The case studies presented by Beck included the production of biopharmaceuticals for the treatment of dystrophic epidermolysis bullosa, or DEB, which is a genetic connective tissue disorder, and two lysosomal storage disorders, one being metachromatic leukodystrophy, or MLD, and the other being Hunter syndrome. In each case, the biopharmaceutical being manufactured was for use in a protein replacement therapy, or in the latter two cases, more specifically an enzyme replacement therapy.

The lifecycle management of the manufacturing process faced quality challenges such as purity and complex structural integrity of the protein necessary for proper function. The challenges were overcome by optimization of cell culture production to improve yield which involved parallel paths of attack such as pursuing alternative host cell lines to not only address yield but also the impurity profile, development of improved analytical methods such as for enzyme specific activity measurement, and fast-tracking formulation. In the case of MLD, an additional set of challenging issues was managing changes in manufacturing such as new unit operations, a new facility, and a new manufacturer, which in part involved bridging studies for drug product comparability, and new supply chain tracking protocol. In the case of DEB, unique challenges arose from the technology being acquired from a virtual company which necessitated that a first step be the aggregation of all existing data for complete and thorough analysis and review by Shire in order to avoid going down the path of reinventing the wheel. And lastly, in the case of Hunters, life cycle management addressed challenges in a retrospective quality by design fashion by “looking at old data through new lenses” to develop some fundamental understanding of critical parameters required for catalytic activity.

In summary, Beck cited success as having to do with development and implementation of science and risk management tools, identifying and building core capabilities, focusing on critical steps at every stage, and streamlining work-flows for design and planning. The conference continues through Thursday March 27th with talks and workshops in four to five daily session topic tracks at the Hilton Bayfront Hotel.


Today's post comes from Gregory T Mrachko a Protein Chemist and Enzymologist. He specializes in protein purification, enzymology, high throughput assay/screen conceptualization/development/implementation, analytical biochemistry, biocatalysis, liquid column chromatography, and protein analytics. He is a guest blogger at this year's Biopharmaceutical Development and Production Week and can be reached at gmrachko@msn.com.



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BDP Week: Takeaways from Day One

Today kicked off Biopharmaceutical Development and Production Week in San Diego.

Here are just a few highlights from today's sessions:

Peter H. Calcott, President, of Calcott Consulting LLC shared that the key content found in any quality agreement should be: purpose/scope, terms (including effective date and termination clause), dispute resolution, responsibilities including communication mechanisms and contracts and change control and revisions.

Fi Alonso-Caplen, Ph.D., the Senior Director, Biotherapeutics & Vaccines Outsourcing at Pfizer, Inc. explained that the guiding principles for externalization that should be taken into consideration are -quality, risk, cost, time, flexibility and adaptability. However, cost is not a major driver. There is consideration for cost in relation to expertise.

Sonia Kansal, Ph.D., Senior Manager, Biotherapeutics & Vaccines Outsourcing at Pfizer and Frank Marchesani, Business Development Executive at Cook Pharmica LLC took a deeper dive into their partnership, which they termed "partnersourcing". They put an emphasis in trust in their outsourcing relationship. This allowed them to streamline their tech transfer for all future projects.

Justin Skoble, Ph.D., Director, Biodefense and Process Development, Aduro BioTech spoke about their streamlined targeted process to hind the correct technology transfer partner. Their step by step methods for a CMO seletion process were:

  • • Define the critical selection criteria and create a list of suitable CMO
  • • Contacted CMOs to determine interest and availability
  • • CMOs prospectively ranked by stated capabilities
  • • Sent RFP to top 6 CMOS for each program
  • • 10 proposals returned
  • • Proposals ranked
  • • Site visits completed
  • • Top CMOs selected
  • • Quality audits scheduled
  • • Final selection made


Vincent Lau, Senior Supervisor, Cell Culture Development, Biogen Idec spoke about the internal technology transfer to an international biotechnology facility. Three things they discovered while moving the internationally were that it was key to have a single person to lead the tech transfer. This allows for simplified information to flow and maintain continuity between programs and relationship building was simplified. One of the negatives was it was difficult to ensure each program received right amount of attention.

We'll be back the next three days bringing you the key take aways from this year's event.  Do you see one of your big takeaways missing from this list?  Comment below!


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Thursday, March 13, 2014

What are some benefits of collaborating with suppliers to manage your raw material supply chain?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he discusses the benefits of collaborating with suppliers to manage the raw material supply chain.

Well, I think the biggest thing is that when you collaborate with your suppliers, you are more often able to create a sustainable solution. One of the challenges is, as a manufacturer, you can say: “Well, we just don’t want our suppliers to change anything”, but that’s not terribly realistic because technology develops and maybe process improvements that they have.

So, I think by collaborating with our suppliers, you create a deeper understanding of the process. And through that deeper understanding and knowledge, you can then intelligently help manage change control with the suppliers when they are going to make changes or they are going to have to qualify new raw material for the process. You can also reduce the variability within the process in areas where maybe the supplier didn’t realize that this certain process attribute or this certain control point actually had an impact in our manufacturing process.

So, by working with the suppliers you can both reduce variability and I also think more effectively manage change control for your manufacturing processes going forward. And you can do it in a way that both organizations can benefit and, I think, ultimately benefit the industry overall by creating solutions which are focused more on being able to manage that inherent variability or changes that are going to have to happen as a part of the change control process. And be able to do it in a way that minimizes any disruptions in the supply chain.


David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.


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Wednesday, March 12, 2014

See who is attending TIDES

http://bit.ly/1dQLtyxWill you be joining these confirmed colleagues at IBC’s 16th Annual TIDES meeting, taking place May 12-15 2014 in Providence, Rhode Island?

Drive your discovery and manufacturing programs forward at TIDES by hearing a world-class group of speakers provide you with the latest science, technology and development updates.

Benchmark your current portfolio by hearing new reports on leading therapeutic candidates in development from Amgen, GSK, Teva, Alnylam, Ophthotech, AstraZeneca and Giuliani SpA. Also, ensure regulatory success by hearing FDA speaker Jeffrey Baker provide insight on how to prepare for the FDA Safety and Innovation Act.

Plus, be the first to access novel technologies and cutting-edge science in our poster and exhibit hall, featuring over 75 exhibitors and 30 peer-submitted posters.

Keynote Speakers Provide Cutting-Edge Science to Accelerate Your Current Project

Peptide R&D: Advances and Opportunities Nader Fotouhi, Ph.D., Vice President, Head of Discovery Technologies, Hoffmann-La Roche

Pharmaceutical Protein and Peptide Engineering Lars F. Iversen, Ph.D., Corporate Vice President, Diabetes Protein Engineering, Novo Nordisk, Denmark

Aptamer Nanotechnology for Therapeutic Nanoparticles Omid Farokhzad, M.D., Associate Professor; Director, Laboratory of Nanomedicine and Biomaterials, Brigham and Women's Hospital, Harvard Medical School

Peptide-Based Vaccines in the New Era of Cancer Immunotherapy Eric von Hofe, Ph.D., President, Antigen Express, Inc.

PeptiDream: From Bench to IPO Patrick C. Reid, Ph.D., Chief Scientific Officer, PeptiDream Inc., Japan and U.S.A.

To learn more, download our brochure.

Register with code XB14180BLOG to receive 20% off of the standard rate. If you have questions about the event, feel free to contact our group manager, Kate Devery (Kdevery@iirusa.com), or visit our webpage. We look forward to seeing you May 12-15 in Providence, RI!

Cheers,
The TIDES Team

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How are biopharmaceutical manufacturers managing the variability within their supplier base?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he shares what he sees as some of the major trends in raw material management strategy from a technical perspective?

I think that there is a variety of ways that they’re doing that. I think what suppliers are doing right now, one of the things suppliers and manufacturers are collaborating on to work together on this is both exchange of data. In the past maybe you just received a certificate of analysis for your final product. Now some suppliers and some customers are exchanging more data. Maybe a certificate of manufacture with a list of the raw materials, maybe it’s a C of A for all the raw materials that were used in the cell culture media. So, they need more visibility to the components – the suppliers of those components – into the manufacturing process.

I think another thing, as well, I think end users and biopharmaceutical manufacturers are doing more work upon incoming receipts. So, they are applying new technologies, such as raman spectroscopy to create a spectral reading, which creates a richer data set on those individual raw materials that are brought in. And then what they can do is employ tools, such as multivarient analysis to be able to detect weak signals from those richer data sets. And that starts to be able to point directionally as to whether or not there are differences lot-to-lot that are impacting the manufacturing process.

I think by combining both some of these analytical tools, such as Ramen and some of the statistical analysis tools, such as multi-varient analysis and then also the increased collaboration with our suppliers and being able to get data set and more visibility to specific places. We are starting now to be able to map out and better understand exactly how components within a complex raw material, such as cell culture media, can impact the process performance in our manufacturing environment.

David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.


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Tuesday, March 11, 2014

How is the growing use of chemically-defined media increasing our understanding of the complexity cell culture manufacturing?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he looks at:
How is the growing use of chemically-defined media increasing our understanding of the complexity cell culture manufacturing?

When you look at the development of cell culture media, originally when we used, for instance, basal media plus fetal bovine serum – and fetal bovine serum was thousands, if not millions, of components in a supplement for the basal media that varied from year-to-year due to its biological origin. Or even when we went to hydrolysate and protein extracts. Once again, maybe it was just mostly protein, but it was thousands of different peptides, some vitamins, trace metals. It was very hard at that point to discern what was influencing or what components individually were influencing the performance of the cell culture process. You might find some markers. You might find some ratios of amino acids, but ultimately it was still fairly difficult. Whereas when you remove the chemically-defined media, at this point now you have a media, it has a defined list components – probably 50 to 70 different components. And that now makes it possible that you can really start to focus in and figure out which components in that media are actually critical to the performance of your manufacturing. And because they are chemically-defined components in the media, you can actually start to discern what attributes of those components are critical to your process performance. From doing that, you can then start to learn, “Okay if these attributes are important in this cell line, can I apply it to other processes? Can I further improve and increase the robustness of my media in such a way to minimize the impact of the variability of this component that is inherent to the manufacturing process?”

So, by moving to chemically-defined media, I think we’ve been able to build our understanding of how individual components in the cell culture process can impact our process performance and better develop strategies to be able to modulate and ensure that our processes are more robust and less susceptible to inherent variability in those cell culture components.


David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.


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Monday, March 10, 2014

What are some of the major trends in raw material management strategy from a technical perspective?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he examines:
What do you see as some of the major trends in raw material management strategy from a technical perspective?

You know, moving forward with raw material management – particularly on the technical side – I think what you tend to see is --- one of the big things is that it is first increasing our visibility to raw materials. I think at one point we just sort of received things in, we looked at the C of A, and we accepted it as is. I think one of the trends you are seeing now are more end users are going out to the suppliers, visiting their manufacturing sites and really gaining a deeper appreciation for the manufacturing processes of those raw materials. And also trying to get visibility all the way back to the point of origin of manufacturing those raw materials.

So, I think one of the things that we’ve gained an appreciation for, as well, is that particularly in the pharmaceutical industry often there are distributors between the point of manufacture and the final customer of that raw material.

I think one of the other areas, both from a risk mitigation and supply chain standpoint – that that has been in the industry a little bit in terms of managing security and supply, but also from a technical perspective – is understanding all the way back to the point of origin and how those raw materials are made because they are not always equivalent across different suppliers or different raw material sources. I think as we gain that understanding, we are starting to be able to make some linkages between the kinds of issues that can arise, depending on the manufacturing process. An example would be a salt mine, for instance, directly or is it maybe a by-product of another manufacturing process. That could impact the impurity profile, for instance, of that salt product that is used in the cell culture media.

I think another area, as well, is going then and actually trying to link the supplier’s raw materials with our manufacturing processes as a customer. I think in the past sometimes, having worked both in the supply side and as a customer, you would supply raw materials to a customer, but you wouldn’t know a whole lot about how those raw materials are being used in the manufacturing process. I think now with increased collaboration between suppliers and the customers, I think we are starting to see more knowledge being exchanged in terms of both the way that a raw material is produced, but then also the way that that raw material is used in the manufacturing process. And that is allowing us, then, to start to be able to connect. Critical attributes in the manufacturing of that raw material to critical process performance parameters in the use of that raw material in manufacturing.


David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.


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Friday, March 7, 2014

How does one ensure comparability across the discovery/development manufacturing continuum?

This week, we've been hearing from Biopharmaceutical Development and Production Week speaker Dr. Janet Wolfe. We've heard about scaling up at an early stage to avoid manufacturing problems, key quality attributes of an ADC, and their characterization  among other things.  Today, we wrap up our interview with Wolfe and look at how to ensure comparability across the discovery and development manufacturing.

The aim of comparability studies is to evaluate the impact of manufacturing changes that typically occur throughout the life cycle of process and product development. So, comparability studies need to be based upon the body of knowledge that has been gained over the course of drug development.

At a very early stage, there is not going to be a huge body of knowledge. But by the time you are approaching commercialization, you will have gained an enormous knowledge of your product and the processes. So, what one wants to be able to do is use the results of comparability studies to verify that the products that are made at each stage have highly similar quality attributes and that they are also functionally equivalent to each other. And you want this all backed up by experimental data. In fact, regulatory agencies will require this.

With the number of variables that are in an antibody drug conjugate – the antibody, the linker, the payload, the variant’s reaction chemistry, the formulation, the process – it means that you could put yourself at risk of not having the same product when you are in the discovery, early development, mid-development or commercialization stage. So, that’s really the entire purpose of the comparability study.

Comparability studies, for them to be well-designed, they require an array of tests. These tests can be typical QC tests, but also bio-physical tests to characterize the molecule. We want to understand what the degradation pathways are, we need to understand the biological assays and the results that you get in those biological assays. You even want to understand the pharmacokinetic behavior of your molecule.

The degree of rigor of these tests is obviously going to change as a function of the development stage.

So, at the discovery and pre-clinical stage the tests are going to be more rudimentary and they are going to be based on the body of knowledge that you required at this point. As you move into early and mid-development the tests are going to be improved. By late stage and commercial stage, the methods are going to be optimized and you may not actually use every method. You are only going to be using the key method that inform where you determine that problems have arisen over the lifecycle of the development pathway. So, at the late stage and commercial stage, typically only the tests that are the most meaningful tests are going to be performed in addition, of course, to all the QC tests. Now, if there are batch failures, then the whole array of tests may be pulled out to identify what the problem was and to fix the problem and keep it from occurring again.

So, I think the whole point of the comparability design is not only to meet regulatory requirements, but it is also a very proactive and worthwhile step for organizations to take. Strategic comparability design ensures that the development lifecycle is conducted in a way to maximize the likelihood of success and minimize extra expenses and risk exposure that is unnecessary.


Janet will be presenting Key Attributes and Considerations for Developing Antibody Drug Conjugate Formulations on Thursday, March 27 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.


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