Friday, September 19, 2014

Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work environment is of assurance, assessment, and assertion, the space of assertion that a company has, process validation (making an assertion and being an advocate, in a data driven way),and the many ways to look at quality by using different tools to evaluate it. Baker stated that he believes that design is about providing an experience.

Want to learn more? Watch the first part of the presentation here:


Biopharmaceutical Development and Production Week is will take place March 30-April 2. The agenda will feature more unique insights into the regulations of biopharmaceutical production so be sure to sign up to receive program updates for the 2015 agenda.


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Thursday, September 18, 2014

Site-Specific Characterization of Glycosylation on Protein Drugs

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Site-Specific Characterization of Glycosylation on Protein Drugs.


BPI_A_141206AR05_O_F0001gA large proportion of biotherapeutic products are glycoproteins. These include erythropoietin and other cytokines, antibodies, glycosyltransferases, and glycosidases, which together generate billions of dollars in sales worldwide. Such drugs are inherently complex. As new treatments emerge and biosimilars are evaluated, the need to better understand their molecular structures is more acute than ever.

Therapeutic glycoproteins are typically produced as recombinant products in cell culture systems. Glycosylation is of major importance during development of these drugs because their glycan chains markedly affect product stability, activity, antigenicity, and pharmacodynamics. A detailed description of the structural features for such carbohydrate-containing molecules is increasingly expected as part of their new drug applications (NDAs) or comparability protocols.

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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Tuesday, September 16, 2014

Alzheimer's Diagnosis and the Role of Biomarkers

Xuemei Zhao, Principal Scientist Merck Research Laboratories 

Alzheimers disease biomarkers marker identification diagnosisAlzheimer’s disease (AD) is the most common form of dementia and it is increasingly prevalent in people over 65 years old.  In developed countries, AD places a tremendous burden on individuals and society.  To date, the cause and progression of the disease are not fully understood.  Although symptomatic therapy has been approved, there is no agent available to stop or reverse the disease.  Many therapeutic candidates are in development with some showing promising results.  Clinical diagnosis of AD relies on characteristic neurological and neuropsychological features.  A definite diagnosis of AD, however, can only be made by examining the neuropathological hallmarks of the disease, amyloid plaques and neurofibrillary tangles, at autopsy.  Therefore, biomarkers that aid in the diagnosis of AD would have great value in the development of AD therapeutics and clinical practice. 

Protein markers in cerebrospinal fluid (CSF) and neuroimaging markers have been shown to contribute to the diagnosis of AD.  CSF protein biomarkers include total tau, phosphorylated tau, and the 42 amino acid form of amyloid-b (Ab42).  Some recently developed positron emission tomography (PET) agents for amyloid deposition imaging are the 11C Pittsburgh Compound B (11C-PIB) and newer, FDA-approved amyloid imaging agents such as Amyvid and Flutemetamol.  Other AD imaging modalities are atrophy on structural magnetic resonance imaging (MRI), and hypometabolism on [18F]fluorodeoxyglucose (FDG) PET.  The validity of these biomarkers of amyloid plaque deposition and neurodegeneration owing to AD is supported by autopsy correlation studies.  Implementation of these markers in the clinic, however, is not ideal in that CSF collection by lumbar puncture is a relatively invasive procedure and PET/MRI measurements are expensive, facility restricted, and may be further limited by personal conditions such as pacemakers.  Therefore, identification of robust biomarkers in an easily accessible body fluid would aid in the early detection of the disease and facilitate development of disease-modifying agents.  


We performed two independent studies, discovery and validation, to identify AD markers by profiling proteins in human plasma using the aptamer-based SOMAscanTM technology.  Specifically, we aimed to identify markers with better performance than the best-performing CSF markers, tau and Ab42, to discriminate AD from non-demented controls.  We constructed a 5-protein classifier in the discovery study and demonstrated that the plasma protein classifier allowed the prediction of AD with 100.0% sensitivity, 80.0% specificity, and 90.0% accuracy in an independent validation study, matching or outperforming CSF tau and Ab42.  Individual-matched plasma and CSF samples were obtained at the same visit, allowing direct comparison of diagnostic performance between the plasma protein classifier and CSF protein biomarkers.  Moreover, the classifier also correctly predicted mild cognitive impairment (MCI), an early pre-dementia state of the disease, with 96.7% sensitivity, 80.0% specificity, and 92.5% accuracy.  These studies demonstrate that plasma proteins could be used effectively and accurately to contribute to the clinical diagnosis of AD.  Although additional and more diverse cohorts are needed for further validation of the robustness, including the support of post mortem diagnosis, the 5-protein classifier appears to be a promising blood test to contribute diagnosis of AD. 

Learn more about Xuemei's work in identifying Alzheimer's disease. 

You can hear more from Xuemei at this year's Bioassay and Bioanalytical Method Development event.  Join us October 20-22 in Boston, MA.  Download the agenda here to see what else is on tap.   

SAVE $100. Register here and use code XP1969BLOG

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What’s Next in Cell Culture & Upstream Processing?

This fall at BioProcess International, we have a track dedicated to Cell Culture & Upstream Processing.  When you join us to learn about this topic, find out more about proven approaches and technologies to reduce timelines and increase efficiency and productivity.

This October in Boston, we look at
  • ● Genomic Tool Implementation
  • ● Synthetic Biology Applications
  • ● Implementing Continuous Processing for Manufacturing
  • ● Commercial Single-Use Applications
  • ● Process Intensification
  • ● Raw Material Integrity Testing
  • ● Media Development and Optimization
  • ● Small Scale Models and Tech Transfers
Companies have experienced many recent achievements to improve quality, cost, efficiency and productivity in cell culture, but what impact will the next wave of disruptive technologies and innovations have on biologics production?

Check Out These Key Case Studies & New Data Presentations Featured in these Informative Cell Culture & Upstream Processing Focused Sessions to Find Out: 
  • • What's Next In Biologics Production New Data & Case Studies from: SAFC, Amgen and Lily Research Laboratories
  • • Improving Product Quality & Control Case Study from: Amgen
  • • Innovation at the Interface of Upstream & Downstream Production New Data & Case Studies from: FloDesign Sonic and Bioprocessing Technology Institute
  • • Improving Efficiency, Productivity and Timelines in Cell Culture New Data & Case Studies from: Genentech, BioGen Idec and Fujifilm Diosynth Biotechnologies
  • • Continuous Processing for Manufacturing (Sponsored by Novasep) New Data & Case Studies from: Sanofi Global Biotherapeutics, Merck & Co, The Pennsylvania State University and BioGen Idec
  • • The Next Wave of Single Use Manufacturing: Closed Systems, New Technology and Cost Comparisons (Sponsored by: Life Technologies and Thermo Scientific) New Data & Case Studies from: Biogen Idec and Bayer Healthcare
  • • Late Stage Cell Culture New Data & Case Studies from: Alexion Pharmaceuticals, AstraZeneca and Merck Research Labs
  • • High-Throughput, QbD and DOE Approaches to Process Development New Data & Case Studies from: Genentech, Biogen Idec and Gallus Biopharmaceuticals

Plus, this Interactive Panel Discussion: How Well do you Know the Raw Materials Used in Your Upstream Manufacturing - Sponsored by BD Bioscience in the Impact of Raw Materials on Product session.

As a reader of this blog, when you register to join us at BioProcess International Conference and Exhibition this October 20-23 in Boston and mention code BPI14BLOG, you can save 20% off the standard rate.  Have any questions or need further information?  Feel free to reach out to Jennifer Pereira.


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Monday, September 15, 2014

Challenges of analytics for complex molecules versus monoclonal antibodies

Dr. Johnson Varghese, the Senior Director and Head of Analytical Development Group at Shire
Pharmaceuticals, recently sat down with the BioProcess International team to discuss establishing criticality of product attributes, challenge are analytics for complex molecules than for monoclonal antibodies and more.

In the interview, he also looks at in-vitro assays that are being developed using biological materials of fibroblast cells with a physiological relevance. Advantages of this method, which is using cells from patients with the disease  and using relevant sub-sprays include assurance of accurate measuring and it allows you to be able to probe conformational aspects of the enzyme.


Dr. Varghese will be the chair of the Analytical and Quality track at the BioProcess International Conference and Exhibition on Wednesday, October 22.  He will be facilitating presentations around the topics of Elucidating the Structure/Function Relationships of Complex Glycoproteins, Elucidating the Structure/Function Relationships of Complex Glycoproteins and facilitating a panel with the speakers of the day's presentations.  For more information on these sessions and the rest of the program, download the agenda.  As a reader of this blog, when you register to join Dr. Varghese at BioProcess International with code BPI14BLOG, you can save 20% off the standard rate.


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Friday, September 12, 2014

Innovation in a Maturing Manufacturing Sector Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech, talks about four innovations in the mAb industry which include: manufacturing consistency, novel drug formats, manufacturing plant design, and drug delivery.  She states that there are two categories of improving manufacturing consistency which are process development approaches and manufacturing technology approaches. She also talks about how one of the most important technologies in the mAb field is data technology.  And one thing they use data technology for is to monitor the health processes.

Watch the Part 2 of her presentation for more information:


Watch Part 1 here.

Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. Sign up to receive email updates as they become available.


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Thursday, September 11, 2014

Hospira Joins Business of Biosimilars, Last Chance to Save is This Friday

At this year's 15th Annual Business of Biosimilars Conference, partner with 100+ movers and shakers in the biosimilars space including pharma, biotech, and legal experts at the leading forum to drive commercialization and market access of biosimilar drugs. By attending, you will learn how to:
  • Identify business opportunities by analyzing the commercial realities of the market
  • Increase market access by expanding your global footprint in the US, EU, and emerging regions via a new "Around the World in One Day" workshop
  • Gain clarity from legal experts on state substitution laws, interchangeability, and takeways of high profile court cases
  • Navigate through regulatory complexities, maximize market uptake, and drive commercial success of a biosimilar drug
Plus! We're excited to announce that Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira has joined the Biosimilars speaker faculty. Hear from him and other industry experts in the below panel:
Looking at the Commercial Realities of the Biosimilar Market
  • •  
    Moderator: John J. Lewis, Senior Vice President, Policy & Public Affairs,           Association of Clinical Research Organizations
  • •  
    Panelists:
    • - Giles Somers, Lead Analyst, Generics and Biosimilars, Datamonitor
    • - Carsten Brockmeyer, CEO, Formycon AG
    • - Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira
Don't miss out on the opportunity to gain a 360 degree view on regulatory complexities, policy adoption, globalization and commercialization of the biosimilars industry. Download the brochure today to see how you can capitalize on the expected growth in the biologic medicines market.

Don't forget! This Friday, 9/12 is your last chance to SAVE $200! PLUS, you can save an extra $100 as a reader of this blog for a total of $300.  Register here and use code XP1986BLOG.


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George Church and Feng Zhang to keynote inaugural Genome Editing Applications conference

IBC Life Sciences, the organizer of market leading events in drug discovery and biologics development, today announced that George Church and Feng Zhang, two world-renowned scientists, will provide the keynote presentations at the Genome Editing Applications conference to be held on March 18-19, 2015 at the Hilton Boston Back Bay, Boston, MA. The Genome Editing Applications conference is the first comprehensive event to focus on the applications of genome editing technologies and genome engineering in therapeutic development, drug discovery and screening and other research applications.

"The emerging applications of genome editing tools hold enormous potential for the development of powerful life saving therapies. Genome editing technologies also offer significant advantages in drug discovery, target validation, screening and other pharmaceutical research applications, including development of gene therapies, cell therapies and immunotherapy. In George Church and Feng Zhang, we are excited to have two of the most respected leaders in the field to share their insights on current and future technologies and applications in genome editing and genome engineering, “said Michael Keenan, Conference Director, IBC Life Sciences.

The event features a compelling program that enables delegates to:
  • • Learn about therapeutic applications of genome editing in cardiovascular disease, gene therapy, stem cell therapy, CART cell immunotherapy, hemophilia B and other advances in in vivo genome editing
  • • Gain an in-depth update on the latest technology advances and applications of CRISPR-Cas9 including a discussion of off-target issues, delivery to cells/tissues, improving specificity and multi-genic alterations
  • • Apply genome editing as a research and drug discovery tool in target identification and validation, genome-scale screening, gene targeting, cell line validation and transgenic animal models
  • • Compare the advantages and disadvantages of CRISPRs, ZFNs, and TALENs for various applications and discover ways to navigate the IP landscape of genome editing technologies for your own projects
For more information about the Genome Editing Applications conference and how to register, visit the webpage.

About the Genome Editing Applications conference
IBC’s Genome Editing Applications conference will showcase the most up-to-date therapeutic and biomedical applications emerging using CRISPRs, ZFNs, TALENs, AAVs and other genome engineering technologies. From validation of targeted cell lines and development of transgenic animal models to therapeutic uses in cell therapy, gene therapy and immunotherapy, this event will also highlight applications in drug target identification/validation and lead discovery and explore how these technologies are being used for whole-genome and functional screening as well as basic research applications. A special emphasis on CRISPR will highlight the design of novel CRISPR constructs and discuss practical aspects of CRISPR including off-target effects, how to improve specificity and delivery to specific cell types, including potential applications in multi-genic alterations. By attending this applications-focused conference you will learn about advances in all of the latest genome editing technologies, including comparisons, advantages and disadvantages of each. You will also learn how to position your company for success in genome editing in the face of the still-evolving IP landscape of CRISPR and other genome editing approaches.

About IBC Life Sciences
IBC Life Sciences, a division of Informa, is your connection to the life sciences industry. Through conferences, webinars, podcasts and its suite of integrated marketing solutions, IBC Life Sciences delivers expert knowledge, valuable connections and customized offerings so customers can meet their goals. www.IBCLifeSciences.com


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Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies.


BPI_A_141206AR07_O_F0001g
Downstream protein purification (the stage in which a protein is isolated and purified) is one of the last steps in biotherapeutic manufacturing. Single-use technologies are an increasingly popular choice for both upstream and downstream bioprocessing because they offer significant benefits over traditional multiuse manufacturing systems. Single-use technologies also provide an array of logistical benefits, including reduced costs, minimized risk of cross-contamination, and improved operational efficiency.

Challenges remain, however, in designing a complete, streamlined, single-use process for downstream protein purification. In-process sensor technologies, chromatography, and temperature control are all areas that have been traditionally underserved by single-use technologies and represent “weak points” in the downstream process flow. Exacerbating the problem, most proteins are heat labile and sensitive to a large number of environmental conditions. Therefore, interruptions in the process and improper temperature management can increase aggregation (which can lead to unstable formulations) or even degradation and denaturation in worst cases.

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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Don’t Miss the Bus….Next Stop: BioProcess International 2014 – October 20-23, 2014 – Boston, MA

Take advantage of the Exclusive Online Back to School Savings – Register for BioProcess International Conference and Exhibition by Sunday 9/14 with priority code BP14FS130 and you will save 30% off the standard rates. This is the best rate available.

Register Now.

The #1 BioProcessing Event for Learning, Networking and Engagement:
The BioProcess International Conference and Exhibition is where the biologics development value chain meets to learn, engage and conduct business. No other industry event delivers the high-level connections and insight needed to accelerate your business.
Questions? Email Jennifer Pereira.

*This promotion is only valid September 11 – September 14 only. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IBC approval.


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Wednesday, September 10, 2014

An Immunogenicity Veteran Shares His Experiences

Robert Kubiak’s professional journey has taken him from the University of Illinois at Chicago to the labs at Johns Hopkins to his current role with MedImmune.  The next stop for Robert will be the 15th Annual Immunogenicity for Biotherapeutics where he’ll be leading a workshop on the Fundamentals of Immunogenicity Assessment. 

Robert will be sharing his experiences in his current role acting as head of a research group focusing on validation of bioanlytical methods.  In addition, he’s worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery as well.  You’ll find some of those experiences cited in the work below:

Kubiak et al. present experimental and theoretical evidence that correlation of the screening and confirmatory results may be a general feature of the tiered approach when the same test platform is used for both screening and confirmatory assays. Presence of such correlation suggests that one of the tiers is redundant and that a single tier (e.g. screening only) can potentially yield the same results as the two-tiered assay.


Following the arguments by Kubiak et al., Sauerborn proposes replacing the current tiered approach to immunogenicity testing with risk-based approach that follows fit-for-purpose strategy.


     Authors of this paper argue that many immunogenicity assays tend to yield screening and confirmatory cut point values that are not reflective of biological variability in the study population. Such cut points, while mathematically correct, tend to result in high number of confirmed positive classifications in drug-naïve populations.


Don’t miss your chance to hear from Robert at IIR’s Immunogenicity for Biotherapeutics event. Join us October 20 – 22 in Boston, MA. Download the agenda to see the list of industry leaders presenting at this year’s event.

SAVE $100. Register here and use code XP1938BLOG

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Tuesday, September 9, 2014

FDA Establishes New "Purple Book" for Biosimilars

It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products and interchangeable biosimilars. 

The organization’s new list will serve a similar role to that of its counterpart in the pharmaceutical industry, the Orange Book, and will look to answer questions around the substitutability of products.  Many have voiced concerns over the extent to which biologics and biosimilars will be used interchangeably.  Although aimed to replicate the biologics they’re designed after, biosimilars are not identical to those drugs and therefore are not necessarily perfect substitutes in all cases.
Purple Book Biosimilars Biologics FDA list licensed

The FDA has indicated that they will use a four part scale to categorize the interchangeability: 
  •         Not similar
  •         Similar
  •         Highly similar
  •         Highly similar with a fingerprint-like similarity

The book is broken up into two sections—biologic products regulated by the Center for Drug Evaluation and Research (CDER) and those regulated by the Center for Biologics Evaluation and Research (CBER). Among the information included in these lists is the date a biologic was licensed, the product name, the proprietary name and the BLA number. 

As we begin to see biosimilar applications roll in, we may see this list build out rather quickly over the next few years. 

You can find the announcement from the FDA here.

We’ll have more on the latest developments in the biosimilars market at the 15thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.
                                                                                                     
SAVE $100.  Register here and use code XP1986BLOG.


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Friday, September 5, 2014

How Can You Better Predict Immunogenicity?

Calculating immunogenicity directly effects your company's bottom line from drugs failing in the clinic to denying patients crucial treatment. Furthermore, the risk of adverse reactions is always existing when creating your product.  

Your company is searching for the Holy Grail to reduce or remove immunogenicity completely from its products. Assessment of immunogenicity continues to be hindered by complications such as pre-existing antibody, manual flow cytometry workflow, and drug interference while interpretation of data is complicated.

IIR's 15th Annual Immunogenicity of Biotherapeutics has a half day dedicated to predicting immunogenicity through a better understanding of underlying causes. You'll also learn about new procedures to adopt to save you money, time, and minimize the immunogenic potential in discovery.

Featured Sessions:


 Next Generation Assays for Immunogenicity Prediction
    Pedro Paz, BR-US-Lead Discovery-Immunoassay/Immunoprofiling Group, Bayer HealthCare LLC

-  Prediction of Clinical Immunogenicity of Adnectins: Guiding Lead Optimization
    Daron Forman, Principal-Scientist, Bristol-Myers-Squibb

-  Improvement of a Sample Pretreatment Procedure for Immunogenicity Testing through Better Characterization of Cells, Positive Control Antibodies and Residual Drug Level
    Weifeng Xu, Research Investigator, Bristol-Myers-Squibb

Download the agenda to see what else is on tap.
Reserve your seat alongside your peers from Sanofi-Genzyme, Shire Human Genetic Therapies (HGT), Boehringer Ingelheim GmbH, and many more already confirmed!  SAVE $100 when you register here and use code XP1938BLOG.

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Innovation in a Maturing Manufacturing Sector

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech, talks about how the column packing robustness is still a problem in this industry. She also talks about novel formats, many ways to bispecific antibodies, and antibody drug conjugates such as Kadcyla. She also mentions ADC- a very high potency drug.She wants it to reach all of the patients around the world. Want to learn more? Watch part two of her presentation:


See Part 1 of Tina's presentation here.

Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. To receive updates about next year's keynote speakers, sign up to receive the latest updates.


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Thursday, September 4, 2014

Process Improvements Increase Production Capacity of a Legacy Product

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Process Improvements Increase Production Capacity of a Legacy Product.



Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process.

The Importance of Postapproval Improvements
Drug development is a complex process, and related business drivers typically shift through a drug’s life cycle. Before market licensure, the emphasis is on ensuring product safety and efficacy during clinical trials in addition to speed to market (left). The need to lock a process in as soon as possible limits opportunities for optimization. As a consequence, process optimization and capacity improvements are often postlaunch activities performed when the scope of market demand and the competitive business environment are both better understood. After a product is launched, related business drivers shift toward cost of goods (CoGs) and ensuring supply to patients while maintaining product quality. After launch and throughout a commercial production life cycle, process optimization is performed within the strict regulatory and quality frameworks of biopharmaceutical products, of course.

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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Biosimilars: Seven Cold Hard Facts

On July 24th the FDA accepted its first application for a biosimilar drug in the U.S. and put the industry on alert that this new market is fast approaching.   While no one knows exactly when the first approval will come, here are a few facts to bring you up to speed for when it does: 

·        Estimates on savings attributed to biosimilars range from $42 - $108 billion over the first ten years of the market.

       The value of biologics slated to come off patent by 2017 is about $70 billion.

 Per the Rheumatology Network, over the span of their lifetime, many drugs approved in the US and EU have eventually become “biosimilars” of themselves.  This is due to a “natural drift” in drug properties caused by changes in production such as using different batches of medium or manufacture at different sites.

         Recently, a group of 19 investors representing nearly $430 billion in assets  commended Novartis and Amgen for supporting a set of investor principles to guide boards on activities related to biosimilars. 

      A survey conducted among senior’s organization RetireSafe shows that 92% were unaware that the Affordable Care Act potentially allows for biosimilar drugs to be substituted for a biologic.  Furthermore, this could potentially be done without the patient or doctor being aware.

 Hospira is looking to file its first biosimilar in the US within twelve months and currently has an R&D pipeline valued at around $40 billion.  

•  Amgen is developing a portfolio of biosimilars of which three are slated to launch in 2017.   

We’ll have more on the latest developments in the biosimilars market at the 15th Annual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA.  Download the agenda to see what’s on tap.

SAVE $100.  Register here and use code XP1986BLOG.


Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
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Wednesday, September 3, 2014

Check Out Who You Can Meet at IBC’s Cell Therapy Event

IBC's 4th Annual Cell Therapy Bioprocessing meeting is less than two weeks away, coming to the Sheraton Pentagon City in Arlington, VA on September 15-16, 2014.

Join these confirmed attendees next month to gain the strategies and approaches you need to overcome your toughest cell therapy challenges:
  • -  Transition your cell therapy from lab to commercial scale by hearing recent case studies on the key scale up considerations aimed at producing commercial successful products
  • -  Gain regulatory approval for your cell product candidate by applying industry-leading strategies to ensure quality, control and safety in your cell therapy candidate
  • -  Ensure good manufacturing practice in your facility by applying biopreservation and product stability techniques to reduce overhead costs, extend shelf-life and improve product stability
  • -  Accelerate your therapy to market by developing processes that are closed, simple and rapid
  • -  Learn about next-generation technologies and products that can push your development and manufacturing programs forward by attending our exhibit and poster hall
Plus! This event provides a great opportunity for you to forge new scientific and business partnerships through networking luncheons, refreshment breaks and evening cocktail receptions.  Download the brochure to see the full schedule.
“As always, IBC produced a topical conference with real world presenters and a chance to network with leading industry.”
- Robert Speziale, VP of Business Development, Invetech

Save 20% off the standard rate*. Register here and use code XB14188BLOG.

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*New registrants only




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One Last Thing Before that Out Of Office Goes Up…



Enjoy your day off AND extra savings! Register for any of the following IIR events and receive a 25% discount off the standard rate*

Mention code
LABORDAYBLOG when registering for each or any of the following:

•  Register here for IIR’s 7th Annual Biorepositories and Sample Management Conference taking place NEXT WEEEK on September 8-10, 2014 in Boston, MA, visit the website for full details.

•  Register here for IIR’s 15th Annual Business of Biosimilars event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

•  Register here for IIR’s 15th Annual Immunogenicity and Biotherapeutics event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

•  Register Here for IIR’s 10th Annual Bioassays and Bioanalytical Method Development event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

Questions? Email Jennifer Pereira.


*This promotion is only valid August 29- September 1st, 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.


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Analytical & Quality at BioProcess International

Attend BioProcess International to stay abreast of emerging analytical tools for non-mAb and next generation biotherapeutics and increasing quality expectations for your products and processes so you can optimize your analytical strategy and reduce quality risk across the product lifecycle.

By attending, you will learn about:
  • ● Physiochemical Characterization
  • ● Variants and Impurities
  • ● Biosimilar Strategies
  • ● Strategies for Complex Glycoproteins
  • ● HT Methods for Stability/Developability
  • ● Quality Risk Management

Featured Session: Elucidating the Structure/Function Relationships of Complex Glycoproteins
  • • Complex Glycoprotein Analysis: Mass Spectrometry-based Approaches presented by Tao He, Ph.D., Associate Research Fellow, Global Biotherapeutic Technologies, Pfizer
  • • Recombinant Protein-therapeutics: Structure-activity Relationship Studies In-vitro and Beyond presented by Yelena Lyubarskaya, Ph.D., Senior Principal Scientist, Analytical Development, Biogen Idec
  • • Testing Strategy as a Holistic Approach: Risk-based Optimization for In-process, Release and Stability Testing presented by Alla Polozova, Ph.D., Principal Scientist, Analytical Sciences, Process Development, Amgen
  • • In vitro Assay Platforms to Asses the Biological Function of Enzymes presented by Peter Bernhardt, Ph.D., Senior Scientist, Analytical Development, Rare Disease Business Unit, Shire
  • • Structure-Function Relationships in Therapeutic Sulfatases presented by Bill Prince, Ph.D., Executive Director, Analytical Chemistry and Formulation, BioMarin Pharmaceutical
  • • Panel Discussion: Strategies and Challenges of Establishing an Analytical Control Strategyfor Complex Biomolecules moderated by Johnson Varghese, Ph.D., Senior Director/Head, Analytical Development, Shire
    • o Establishing criticality of product attributes
    • o Process control for critical quality attributes
    • o Defining the overall analytical testing strategy using the QbD paradigm
    • o State and suitability of the in-vitro bioassays for measuring product quality

Featured Session: Characterization and Control of Variants and Impurities
  • • Emerging Concepts in Process Characterization for Host Cell Proteins: Potential Impact on Biosimilars and Biotech Products presented by Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
  • • Sequence Variant Analysis and Control of a Recombinant Monoclonal Antibody Therapeutic presented by Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, A Member of the Roche Group
  • • An Unexpected Chemical Modification of a Recombinant Monoclonal Antibody presented by Chris Chumsae, Ph.D., Senior Scientist II, Protein Analytics, AbbVie

Featured Two Day Training Course: Quality Risk Management Across The Biopharmaceutical Lifescycle
This course covers how Quality Risk Management pertains to all stages of the biopharmaceutical lifecycle, from drug development through to patient use and pharmacocompliance. Using case studies, practical examples, and interactive discussion, the instructor will help you learn about or expand your current knowledge of Quality Risk Management. This course will provide you with essential knowledge to make better decisions and include discussions of quality risk management considerations related to: analytical tools, risk-assessment of 'different' applications (e.g., single-use, facility, closed systems), phase-appropriate Quality issues, Quality-by-Design, regulatory ICH guidelines, Continuous Process Verification, knowledge management and much more.

Instructor:
Ben Locwin, Ph.D., Head of Training & Development, Risk and Decision Sciences, Lonza Biopharmaceuticals

Find out more about the Analytical & Quality features at BioProcess International Conference & Exhibition by downloading the brochure.  If you'd like to join us in Boston October 20-23, as a reader of this blog, when you register to join us and mention code BPI14BLOG, you're eligible to save 20% off the standard rate.


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Tuesday, September 2, 2014

Analytical and Quality in biopharmaceutical manufacturing

Today, we feature the suite of Analytical and Quality podcasts that BioProcess International Magazine has conducted with speakers leading up to the BioProcess Intenrational Conference and Exhibition taking place October 20-23.  The Analytical and Quality tracks will be taking place Tuesday, October 21-Thursday, October 23 and will feature presentations from Genentech, Roche Diagnostics, ImClone Systems and more.

Here are three interviews we conducted with speakers in preperation for this track:
  • Strategies and Challenges of Establishing an Analytical Control Strategy for Complex Biomolecules
  • -By Johnson Varghese, Senior Director and Head of the Analytical Development Group, Shire
  • >In this podcast, Johnson discusses the establishing critically of product attributes, the difference in analytics between monoclonal antibodies and complex molecules, and the current state is of in-vitro bioassays for measuring product quality.

  • Strategies for Continued Process Monitoring of Commercial Cell Culture and Purification at Large Scale
  • -By Pawel Drapala, Senior Process Engineer, Technical Manufacturing Services, Alexion Pharmaceuticals
  • >The importance of continuous process modeling in a highly regulated market, the tools and equipment are you using for process monitoring of large-scale monoclonal antibodies manufacturing, important process parameters are in terms of quality assurance and more.

  • Microbial Control: What’s Bugging You?
  • -By Sarah Thomas, Site Quality Director, GlaxoSmithKline
  • >In this podcast, Thomas discusses the microbial contamination and the increased amount of oversite, the potential avenues are for microbial contamination in the biopharmaceutical manufacturing environment, the types of process monitoring tools can be used to detect microbial contamination and more.

BioProcess International Conference and Exhibition will take place October 20-23, 2014 in Boston, MA.  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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