Friday, August 22, 2014

Flexible Bioproduction Technologies and Facilities

In today's featured presentation from Biopharmaceutical Development and Producion Week 2014, Thomas Warf, Director, Manufacturing, Facilities and Engineering, BARDA, U.S. Department of Health & Human Services talks about how the government is entering the vaccine industry. He states that the companies have to apply like the vaccine is a commercial product, and talks about how there was almost a pandemic in 2009, and how they delivered more doses of the vaccine for this pandemic than ever before.He also states that this was the first product that was approved for animal trials. To learn more watch the presentation:


Biopharmaceutical Development and Production Week 2015 will take place March 30-April 2 in Huntington Beach, California. For the latest program announcements including the call for speakers and program release, sign up for email updates.


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Thursday, August 21, 2014

Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies.



WWW.COOKPHARMICA.COMOver the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule.

The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus, a significant investment is being made to assure that molecules entering the pipeline are successful. It is therefore imperative to take an integrated approach to cell-line development and early stage screening and process development. This enables companies to make appropriate, timely decisions about pursuing therapeutic candidates for preclinical and clinical manufacturing.

A critical part of biopharmaceutical development is choosing the right cell line with the objective of confirming cell productivities, cell-line stability, and final-product quality. For a proof-of-concept program outlined herein, Cook Pharmica and Selexis were able to successfully develop a productive cell line, design an efficient process, and scale up a commercially available antibody. Selexis generated the high performance SURE CHO-M cell line that was used in Cook’s rapidly scalable development process at its state-of-the-art CGMP biologics manufacturing facility in Bloomington, IN. Current data from the program demonstrate comparability to the originator drug while achieving commercial-ready titers up to 4 g/L.

Read the full article here.



You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.



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Wednesday, August 20, 2014

BioProcess International 2014 Symposiums Highlights

In addition to all the programming the BioProcess International conference offers you, IBC has even more programming choices for you by making the five pre-conference symposia available as either an add-on to your 3 or 4 day conference registration, as a stand-alone learning experience, or you can combine with an exhibit hall & keynote pass.

Isn't It Great to Have Choices?  Here are your symposium options for this year:

  1. Antibody-Drug Conjugates - Developing ADC Technologies to Increase Therapeutic Windows: Understand how to apply novel linkers, conjugation methods and payloads to develop, scale up and manufacture next generation ADCs.
  2. Innovation through Integrated Process Development Sponsored by: 3M: : Learn how Innovation through Integrated Process Development provides step change solutions to bioprocesses. Delivering purity to process fluidity leading to process efficiencies and better process economics.
  3. Cell Therapy Bioprocessing: Discover how to successfully develop and manufacture cell therapies and achieve commercial success through technical and process innovations.
  4. Optimize Processes and Improve Raw Materials Continuity and Transparency: Improve your supply chain with the latest techniques to trace your raw materials, better collaborate with suppliers, and troubleshoot the performance of your processes.
  5. Knowledge Management across the Product and Process Lifecycle: Learn how to apply data from your process development and manufacturing operations on an ongoing basis to your next project/run to improve efficiency, quality and control.

Plus, register for the knowledge management symposia and be entered to win a free copy PAT Applied Biopharmaceutical Process Development Manufacturing courtesy of CRC Press.


BioProcess International Conference and Exhibition will take place October 20-23 in Boston.  As a reader of this blog, you can register to join us with priority code BPI14BLOG and save 20% off the standard registration rate.  Have any questions about the symposiums or want to get involved?  Reach out to Jennifer Pereira.


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BioProcess International Poster Preview: Case Studies of hERG Membrane Protein and Japanese Encephalitis Virus Production Using a New Innovative Moving Bed Bioreactor

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2014 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Case Studies of hERG Membrane Protein and Japanese Encephalitis Virus Production Using a New Innovative Moving Bed Bioreactor

Presenter: Lewis Ho,  BioReactor Sciences

About: Human ERG membrane protein has gained great interest as a target for drug discovery. A two fold increased expression of the hERG gene was induced under nutrient limitations. The protein is membrane bound and therefore whole cell recovery from the carriers is required. HEK293 cell was used. Japanese encephalitis virus (JEV) for vaccine has long been the only reliable solution to prevent deadly encephalitis. The virus however is unstable and post-infection conditions for optimal virus production and recovery is critical. We use two case studies to illustrate a new innovative Moving Bed (MB) bioreactor’s unsurpassed versatility and functionality to accommodate specific desired conditions and to accomplish the entire upstream processes in one single bioreactor. The mobility of the moving matrix bed allows for the least amount of volume required for seeding, yielding high seed density resulting in increased cell attachment. Similarly, this feature results in high virus infection and DNA transfection efficiency. The MB system facilitates the principle similar to roller bottles intermittently exposing and submersing cells to air and medium to achieve maximum oxygenation with near minimal shear, and also eliminating foaming issues. The moving bed sets a new precedent in performing the mechanism of cell detachment and recovery in place.

Are you interested in presenting your own findings? BioProcess International is accepting poster submissions through September 19.  For more information and how you can submit your poster to be presented in the poster hall, visit our BioProcess International Poster Page.


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Tuesday, August 19, 2014

FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."


The biosimilars news is going to keep coming. We’ll have the breakdown of the latest industry updates and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100Register here and use code XP1986BLOG.

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New Antibody Technology and Enhancing Quality

In today's featured interview from Antibody Engineering 2013, Co-founder and Chief Scientific Officer of Larix Bioscience LLC, Bo Yu, talks about how Larix Bioscience had just developed a new technology called the antibody switch. He also talks about some of the companies goals such as streamlining antibody engineering, reducing cost while enhancing quality. In this interview Yu states that one way to achieve this quality is to access this quality in the early stages of development. He also states that one of the trends in the antibody engineering industry is improved product quality.

What is this "antibody switch"? Watch the interview to find out:
 

The 25th Annual Antibody Engineering &Therapeutics Event will take place December 7-11, 2014 in Huntington Beach, California. To find out more about this year’s speakers and topics, download the agenda. If you’d like to join us, as a reader of this blog, when you register and mention code XD14172BLOG, you’ll save 20% off the standard rate.


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Friday, August 15, 2014

Complex Medicines & Global Drug Delivery

In today's featured interview from Biopharmceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech talks about the four major opportunities in the drug delivery industry, and challenges in this industry. The four major opportunities include: improving drug-delivery to improve outcomes for patients, developing more complex medicines for patients, improving facility design and improving consistency for these drugs. She states that a challenge in this industry is delivering sophisticated medicines. She also says one opportunity in this industry is to scale these medicines globally. To learn more check out this interview:



Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. To stay up to date on the latest about next year's program, sign up for email updates.


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Thursday, August 14, 2014

Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies.


For successful development and marketing of biosimilars with desired efficacy and safety, this industry recognizes the central importance of extensive analysis comparing innovator and biosimilar molecules. It is also recognized in the biotechnology arena that our understanding of complex biologics remains limited even though we have many analytical technologies available to us. A recent FDA guideline for biosimilar development states the following:

The three-dimensional conformation of a protein is an important factor in its biological function. Proteins generally exhibit complex three-dimensional conformations (tertiary structure and, in some cases, quaternary structure) due to their large size and the rotational characteristics of protein alpha carbons. The resulting flexibility enables dynamic, but subtle, changes in protein conformation over time, some of which may be absolutely required for functional activity. . . At the same time, a protein's three-dimensional conformation can often be difficult to define precisely using current physiochemical analytical technology. (2)

With an understanding of our current capabilities in biologics higher-order structure (HOS) characterization, we developed an antibody array enzyme-linked immunosorbent assay (ELISA) to provide a new approach for evaluation of MAb HOS.

In a previous report, we showed that antibody arrays developed specifically toward marketed MAbs could detect structural differences that correlated well with other analytical readouts, including bioassays and glycosylation analysis (8). Experiments have shown that antibody arrays can detect subtle changes that sometimes were not detected by bioassays or any other analytical technologies currently available.

The arrays use more than 30 polyclonal antibodies to cover an entire MAb molecule, thereby measuring its surface-epitope distribution systematically and sensitively, whereas other assays measure only part of the molecule or give an average status of a biologic's population. So antibody array technology should be able to provide a unique measurement of biosimilar MAb HOS comparability. We suggest that additional surface exposure from a baseline readout be termed conformational impurity(8).

Another advantage for antibody array technology is its ability to quantify small amounts of conformational impurity using an easy-to-operate ELISA format. As little as 0.1% conformational differences could be detected from all areas covered by the polyclonal antibodies, thus providing for accurate and sensitive measurement of the status of a MAb's conformation. No data yet correlate the impact of conformational impurity with efficacy and safety of a biosimilar MAb. But it is reasonable to postulate that more conformational impurities (epitope exposures) would increase the risk for potential immunogenicity if those additional epitopes were originally inside the innovator MAb molecule, which has been proven to be tolerated by patients’ immune surveillance systems. A significantly different new epitope exposure could break self-tolerance to a MAb and induce immunogenicity. Furthermore, increased exposure of new epitopes raises the possibility of a biosimilar MAb interacting with other regulatory proteins in a patient's body, causing off-target effects.

Read the full article and see detailed illustrations here.



You can find out more about manufacturing process and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.





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Wednesday, August 13, 2014

Improved Immunogenicity, Rapid Action of Anthrax Vaccine

Soligenix, a company developing vaccines for inflammatory diseases and biodefense, has released results demonstrating improved immunogenicity for VeloThrax™, the company’s anthrax vaccine.

VeloThrax™ is a proprietary recombinant Protective Antigen (rPA) vaccine of Soligenix.  It had been believed that VeloThrax™’s improved immunogenicity could result in a vaccine with the potential to be administered in fewer doses.  Recent results prove that this is in fact the case. 

Immunogenic response vaccine velothrax immunogenicityNext generation anthrax vaccines had aimed for fewer vaccinations over a shorter period of time for both pre and post exposure use.  While the current vaccination requires as many as five administrations over an 18 month period, recent developments with VeloThrax™ show that it’s capable of producing the necessary immune response with only two doses in less than a month’s time.   
The enhanced vaccine was developed by stimulating receptor 4 (TLR-4) which plays an important role in the recognition of pathogens.  The stimulation of these receptors resulted in a boost to toxin neutralizing antibodies and triggered an elevation in immune responses in mice after just one immunization. 

The improved vaccine also proved to be stable at 40 degrees Celsius for up to three months as well as up to 70 degrees Celsius for one month.  This alleviates some of the burden in storing the vaccine. 

“We are very pleased that our enhanced anthrax vaccine, VeloThrax™, has demonstrated promising results indicative of rapid onset of protective immunity," explained Christopher J. Schaber, PhD, President & CEO of Soligenix. "These data demonstrate the potential of creating a rapidly acting anthrax vaccine with the ability to withstand temperature extremes thereby avoiding the need for cold chain management. We believe that stability at such elevated temperatures provides a distinct advantage over other anthrax vaccine technologies currently in development. Further, DNI rPA is highly immunogenic and offers the potential for complete immunization with just one or two doses.”

Schaber says he expects his company to continue to develop the vaccine.  The ultimate goal?  A position as an anthrax vaccine for “stockpiling by the US government”.

Want more on the latest in immunogenicity?  Join us at the Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100Register here and use code XP1938BLOG.

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1st Annual Women Leaders in Pharma and Biotech Dinner Series

IIR is committed to the support and growth of women in the life sciences industry and after much success with the annual Women's Clinical Leadership Forum at the Partnerships in Clinical Trials conference, we're thrilled to introduce the Inaugural Women Leaders in Pharma & Biotech Dinner Series:

October 20, 2014 | 6:00 – 8:30PM
Omni Parker House | Boston, MA



We invite established leaders and up-and-comers in the pharmaceutical industry — both women and men of all levels — to attend.

Take part in lively and open conversation amongst leaders in the biomedical, bio-technology, diagnostic, health informatics, healthcare, medical device, and pharmaceutical sectors as they discuss strategies to help women work their way up the life sciences ladder.

Don’t forget to check out IIR’s other events in Boston this October 20-22:


Questions? Contact Marina Adamsky


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Tuesday, August 12, 2014

Biologics, Antibody Engineering and Cancer Treatment

In today's featured interview from Antibody Engineering 2013, Jane K. Osbourn, Ph.D., Vice President, R&D and Head of Biosuperiors, Medimmune, United Kingdom, talks about how there were great strides made in biologics for cancer treatment. She states that there the opportunities and challenges are mixed as more technology is moving this field into fruition but brings the challenge of how to spent their resources efficiently.  She also looks at how biologics and antibody engineering can be used for cancer treatment. Watch the interview to learn more:


The 25th Annual Antibody Engineering & Therapeutics Event will take place December 7-11, 2014 in Huntington Beach, California. To find out more about this year’s speakers and topics, download the agenda. If you’d like to join us, as a reader of this blog, when you register and mention code XD14172BLOG, you’ll save 20% off the standard rate.


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Monday, August 11, 2014

Could Gene Therapy Replace the Need for a Heart transplant?

Could gene therapy help avoid a heart transplant?  We’ll soon be one step closer to knowing the answer thanks to a groundbreaking trial in the UK.  Lee Adams, 37, is the first of an eventual 24 patients who will take part in a trial to see if Mydicar, a treatment from U.S. biotech firm Celladon, can help overcome advanced heart failure. 

The treatment is designed to deliver a spike in SERCA2a protein in the heart muscle.  The SERCA2a protein is responsible for making heart muscle contract and low levels have been known to make the heart pump weakly.  The protein will be delivered to the heart via harmless virus.  Researchers plan to take a samples after an initial six month period to measure the presence of the gene.  For those that undergo a subsequent transplant, the researchers will be able to examine the actual heart as well.

Gene Therapy Heart Transplant SERCA2a Protein TreatmentOf the 24 patients the study plans to involve, 16 will receive the actual treatment while the other eight are given placebos.  Like Adams, these patients have advanced heart failure and rely on Left Ventricle Assist Devices (LVAD) to keep them alive while they await a transplant. 

The trial, led by Imperial College London and funded by British Heart Foundation as well as Celladon, claims to be the first in the world to investigate the use of gene therapy to correct heart failure. 

Says Professor Sian Harding, who helped develop the treatment, “It's important to remember that the therapy is not correcting a gene defect. We are working much more downstream, which means that no matter what the cause of the heart failure, the therapy should be equally beneficial for patients whether their heart problems stem from genes, lifestyle or the environment or a mixture of all of these."

Adams has a reserved optimism towards the study.  "Of course the best thing that could happen would be for my heart function to show signs of improvement and for the gene therapy to prove to be a 'miracle cure' for myself and other patients. But I'm not building up my hopes too much because, for all I know, I might have had the placebo.”

Here’s to hoping it is the “miracle cure”.

What else is new in the field of cell therapy?  Join us for the Cell Therapy Bioprocessing conference, September 15-16, Boston, MA.  Download the agenda to see what’s on tap.

SAVE 20%* off the standard rate as a reader of this blog. Register here and use code XB14188BLOG.

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Biosimilars Can Save Money and Lives. Why the Delay?

Biologic drugs are used to treat a number of serious, life threatening diseases and save countless lives.  They are, however, exceedingly expensive.  The average daily cost of a biological in the U.S. ($45) dwarfs that of chemical drugs ($2).  Annually, some of these drugs can cost patients as much as $400,000.  The question becomes “how do we make these treatments more sustainable?”  The short answer to that question centers around biosimilars as one study estimates they have the potential to save north of $250 billion from 2014 to 2024. 
 
The long answer to that question, however, is not as straight forward.  Manufacturers of biological drugs can continue to charge monopoly prices as long as those drugs remain under patent protection.  Even as these medications begin to come off patent, many over the next few years, the road for biosimilars to enter the market is not exactly paved.  While many other countries (Australia, Canada, and the EU specifically) have had a market for biosimilars since 2006, the US policy for entry of these drugs remains ambiguous. 

Biosimilars Money Savings Patients FDA Cost Drug Biologics
A big part of this delay can be attributed to the FDA’s lack of progress in establishing guidelines for the approval of biosimilars.  Although they did accept their first biosimilar application last week, there still lacks a definitive set of regulations.  Tentative guidelines had been provided both in 2012 and 2014 but a final set is still in progress. 
This uncertainty in the regulatory process has caused apprehension among many drug companies and left fewer players vying for a place in the market.  Said one pharmaceutical executive, “I would like absolute clarity before we make a large investment. The quality of the decision is worth more than speed.”

While the FDA wavers in putting a process in place, biologics manufacturers have engaged in stall tactics.  The longer biosimilar drugs stay off the market, the longer these companies can continue to enjoy massive profits—reportedly as much as $100 million a month for some drugs.  The latest strategy employed involves disputing the naming system to be put into place for these drugs.  Biologics manufacturers have lobbied to maintain separate names, and the equity that goes with those names, from competing biosimilars.

While this dispute carries on, patients are missing out on billions of dollars in savings.  Many have called for the FDA to re-calibrate their priorities and fast track a set of guidelines that would allow biosimilars to hit the market sooner.  Other countries have had regulations in place for almost eight years while we wait for officials to perfect ours.  Until then, drug companies will continue to pad their pockets with massive profits from these drugs.   

Biosimilars is projected to be a lucrative industry. Can you afford to miss out? We’ll have the latest industry news and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
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Inside BioProcess International: Kenneth Green, Ph.D., Director, Global Technical Services, Pfizer

BioProcess International Magazine is releasing a series of podcasts over the summer to prepare for the BioProcess International Conference and Exhibition taking place this October in Boston. Next up in our exclusive podcast series is an interview with speaker Kenneth Green, Ph.D., Director, Global Technical Services, Pfizer.

In his interview, Dr. Green discusses the common risks of raw material with cell cultures, how vendors control risk management for raw materials and how predictive modeling can affect risk management of raw materials.


Dr. Green will be at the BioProcess International Conference and Exhibition on Thursday, October 23 to present The Application of Risk Assessments to Identify and Mitigate Material Risks.  To find out more about his presentation and the rest of the agenda, download the brochure here.  If you'd like to join us October 20-23 at the event in Boston, as a reader of this blog, when you register to join us and mention BPI14BLOG, you can save 20% off the standard rate.


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Thursday, August 7, 2014

Stay cool this summer with a 25% savings! Register by August 15 and save 25% off the standard rate!

Register now to get your cool savings off IIR’s 15th Annual Business of Biosimilars event with a 25% discount off the standard rate!*


Register here to join us and mention code XP1986Cool to take advantage of this discount.

The Biosimilars event will take place October 20-22, 2014 in Boston, MA, visit the website for full details.  
Download the agenda here to see what’s on tap.

Have any questions? Email Mike Madarasz.


Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn


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Stay cool this summer with a 30% savings! Register by August 15 and save 30% off the standard rate!

Register now to get your cool savings off IIR’s 10th Annual Bioassays and Bioanalytical Method Development event with a 30% discount off the standard rate!*

Register here to join us and mention code XP1969Cool to take advantage of this discount.

The Bioassays event will take place October 20-22, 2014 in Boston, MA. Visit the website for full details. Don’t forget this event is co-located with IIR’s 15th Annual Immunogenicity for Biotherapeuticslearn more here.

Download the agenda here to see what’s on tap.

Have any questions? Email Mike Madarasz.

Don’t miss a thing. Sign up for our email updates
Follow us on Twitter
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Stay cool this summer with a 30% savings! Register by August 15 and save 30% off the standard rate!

Register now to get your cool savings off IIR’s 15th Annual Immunogenicity for Biotherapeutics with a 30% discount off the standard rate!*

Register here to join us and mention code XP1938Cool to take advantage of this discount.  

The Immuno event will take place October 20-22, 2014 in Boston, MA. Visit the website for full details. Don’t forget this event is co-located with IIR’s 10th Annual Bioassays and Bioanalytical Method Development event—learn more here.

Have any questions? Email Mike Madarasz.


Follow us on Twitter
Join us on LinkedIn
Don't miss a thing. Sign up for our updates

*This promotion is only valid until August 15, 2014. Discount is not applicable to the Super Pass or Super Pass+




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Wednesday, August 6, 2014

Formulation & Delivery Strategies You Need for Next-Generation Biologics and Protein Therapeutics

This year, the formulation and delivery track at BioProcess International will focus on how to apply innovative technologies and phase-appropriate strategies for formulation development and delivery of mAbs, next-generation biologics, non-mAb protein therapeutics, vaccines and other modalities.

The formulation & delivery track at BPI will teach you how to apply innovative technologies and phase-appropriate strategies for formulation development and delivery. Find new ideas for your mAbs, but even more importantly, learn about formulation development for next-generation biologics, non-mAb protein therapeutics, vaccines and other complex molecules. Discover pre-formulation strategies and techniques for assessing liabilities of molecules to ensure you are progressing candidates with a good chances of success. Hear the latest in high-throughput methods for formulation development. Learn about the connection between formulations and protein/peptide stability and physiochemical characteristics of your molecules.

This track has been designed to showcase new data and multiple case studies from a variety of different molecules to give you new ideas for your own projects. There are also several shared sessions with the analytical track at BPI to help you cross-fertilize ideas regarding analytical strategies for formulation development with attendees of that track.

Agenda at a Glance

Physiochemical Characterization Strategies
  • • Case Study: Assessment of Higher Order Structure Techniques (CD, FTIR and NMR) for Characterization and Comparability of Monoclonal Antibodies
    • >Jasper Lin, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
  • • Case Study * New Data: Investigation of Glycan-Structure Function Relationship of an IgG1 using In Vitro Glycoengineering
    • >Marco Thomann, Ph.D., Manager Development Analytics, Roche Diagnostics GmbH, Germany
  • • Particulates Monitoring and Control Strategy for Protein Therapeutics
    • >Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.

Stability of Protein and Peptide Therapeutics
  • • New Data: Photodegradation of Therapeutic Proteins under Drug Product Manufacturing Relevant Light Conditions
    • >Li Yi, Ph.D., Technical Development Scientist, Genentech, A Member of the Roche Group
  • • Case Study: Formulation Robustness Studies for a High Concentration Antibody Product
    • >Xiaofeng Lu, Ph.D., Principal Research Scientist, AbbVie Therapeutics Inc.
  • • Case Study: Insight into a Complex Degradation Profile: Sometimes the Obvious Answer Isn't the Right Answer
    • >Rachel Varney, Scientist II, Formulation Sciences, MedImmune, United Kingdom

Biosimilar Development and Characterization
  • • The Far Side of Analytical Development of Biosimilars
    • >Roxana M. Butoi, Ph.D., Manager, Analytical Development, GlaxoSmithKline
  • • Recent Developments with Biosimilars in the US
    • >Emily Shacter, Ph.D., Consultant, ThinkFDA, LLC
  • • Analytical Challenges during the Development of a Biosimilar
    • >Hugh D. Conlon, Principal Scientist, Analytical Research and Development, Pfizer

High-throughput Methods and Analytics to Asses Stability & Developability
  • • High-throughput Screening and Early Analytics to Asses Drug-like Properties and Manufacturability
    • >Patricia Lowden, Scientist II, Eleven Biotherapetuics
  • • New Data: High-throughput Protein Covalent Aggregation Measurement by Automated Simple Western Blot System Using Cell Culture Material
    • >Janet Lau, Ph.D., Scientist I, Cell Culture Development, Biogen Idec
  • • Case Study * New Data: High-throughput Characterization and Stability of Biologics
    • >Leena Philominathan, Ph.D., Scientist, Analytical Sciences, Alexion Pharmaceuticals

Pre-formulations, Developability and Liability Assessments
  • • New Data: A Holisitc Approach to Early Pre-formulation and Developability Studies Can Inform and Speed up Later HCLF and Process Development Work
    • >Mark Krebs, D. Phil, Senior Scientist, Protein Pharmaceutical Development, Biogen Idec
  • • New Data: Use of Intrinsic Viscosity to Quantitate Protein-protein Interactions for Predicting Drug-like Properties in Solution
    • >R. Joe Carrillo, Ph.D., Senior Scientist, Pre-formulation, Abbvie Bioresearch Center
  • • Case Study * New Data: Measurement of Charge: An Important Molecular Property for Predicting High Concentration Behavior
    • >Sumit Goswami, Ph.D., Senior Scientist, Biotherapeutics, Pharmaceutical R&D, Pfizer

Formulation Development Case Studies
  • • Case Study: Phase-Appropriate Formulation Development for Late Stage Monoclonal Antibodies - Successes and Lessons Learned
    • >Angela W. Blake-Haskins, Ph.D., Manager, Biopharma, Drug Product Sciences Department, GlaxoSmithKline
  • • Case Study * New Data: Formulation Development Case Studies
    • >Carsten Olbrich, Ph.D., Senior Scientist, Formulation Development, Bayer Pharma AG, Germany
  • • Case Study * New Data: Rapid Reformulation of an Enzyme Product to Improve Particle Formation and Stability
    • >Victoria A. Dowling, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma, Inc.

Vaccine Formulation Development
  • • Innovative Characterization Methods to Identify an Optimal Vaccines Drug Product Formulation
    • >Patrick Ahl, Ph.D., Assistant Principal Scientist, Vaccine Drug Product Development, Merck Research Labs
  • • New Data: Biophysical Characterization of Flublok, a Recombinant Hemagglutinin (rHA) Influenza Vaccine, by Differential Scanning Fluorimetry
    • >Erin Matthews, Ph.D., Group Leader, Analytical Development, Product Realization, Protein Sciences Corporation
  • • New Data: Reinventing the Gene Vaccine: Stabilization and Delivery of Self-amplifying mRNA
    • >Luis Brito, Ph.D., Head, Formulation Science, Novartis Vaccines

Formulations Development for Next-Generation and Complex Molecules
  • • New Data: DoE HTP Plate-based Antibody Drug Conjugation Formulation Screen for Optimal Buffers and Excipients: Accelerated Stability Characterization of Physical and Chemical Stability
    • >Stanley Kwok, Ph.D., Senior Scientist, Formulations, Fill/Finish, Seattle Genetics
  • • Case Study: Formulation Perspectives of Therapeutic Peptides
    • >Ana Santos, Ph.D., Formulation Senior Scientist, Biopharmaceutical Development, MedImmune, United Kingdom
  • • Case Study * New Data: Formulation Development of PEGylated Biologics: The Effect of Linker Chemistry on the Stability of the Polymer Conjugate
    • >Roger H. Pak, Ph.d., Senior Principal Scientist, BioTherapeutics Pharmaceutical R&D, Pfizer, Inc.

Innovative Formulation and Delivery Approaches
  • • Case Study * New Data: Formulation Strategies for Developing Innovative Combination Products for Rare Diseases
    • >Sujit Basu, Ph.D., Head, Drug and Combination Products, Global Technical Operations, Shire
  • • Delivery of Biologics by Microneedles: Manufacturing Capability and Clinical Readiness
    • >Daniel Dohmeier, MTS Formulation Development Group Leader, 3M

Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities

Speakers and Panelists:
  • • Jeffrey Skene, Acting Chief, Monoclonal Antibodies Division, Health Canada
  • • Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
  • • Joel Gates, Director of Quality Assurance, Shire
  • • Alex Tschumakow, Director, Manufacturing, Shire
  • •Anastasia Lolas, Owner & President, Visionary Pharma Consulting LLC
  • • Paul Smock, Biotechnology Quality and Technical Consultant

Would you like to join us for the Formulation and Delivery track featuring insights from companies like ImClone Systems, Roche, Abbvie Therapeutics, MedImmune and more? As a reader of this blog, when you register to join us at BioProcess International Conference and Exhibition October 20-23 and mention code BPI14BLOG, you can save 20% off the standard rate! Have any questions or want to get involved? Feel free to reach out to Jennifer Pereira.


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Monday, August 4, 2014

Inside BioProcess International: Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech

BioProcess International Magazine is releasing a series of podcasts over the summer to prepare for the BioProcess International Conference and Exhibition taking place this October in Boston. Next up in our exclusive podcast series is an interview with speaker Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech.

In this podcast, he discusses the Unican technology.  He goes in-depth on single use biorectors and where they fit into Genentech's manufacturing.  Chan also discusses how relying on one vendor and market instability are affecting manufacturing.  He also  looks at what instabilities in the supply chain lead to their decision to go with single use bioreactors.


Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech will be at BioProcess International Conference and Exhibition on Thursday, October 23 to give the presentation UNICAN: Dual Capability in Single Use Bioreactor . To learn more about his presentation and the rest of the program, download the agenda here. If you'd like to join us October 20-23 in Boston, as a reader of this blog when you register to join us and mention code BPI14BLOG, you can save 20% off the standard rate.


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Friday, August 1, 2014

Lowering Cost and Increasing Efficiency of Antibody Engineering: Geoffrey Yarranton, Kalobis Pharmaceuticals

In today's featured interview from Antibody Engineering 2013, Geoffrey Yarranton, Chief Scientific Officer and Executive Vice President of Research and Development of Kalobios Pharmaceuticals, Inc talks about how the antibody industry is maturing. He also talks about the many challenges of antibody engineering such as the cost of the goods needed fore development, and how to make antibodies cheaper while increasing the length of which these antibodies remain in the human body and reducing the frequency in which the dose of the antibodies are given in. What does this mean for the future of antibody engineering? Watch the interview to find out:


The 25th Annual Antibody Engineering Therapeutics Event will take place December 7-11, 2014 in Huntington Beach, California. To find out more about this year’s speakers and topics, download the Agenda. If you'd like to join us, as a reader of this blog, when you register and mention code XD14172BLOG, you’ll save 20% off the standard rate.


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