Look Who's Attending | Last Chance to Save up to $400

Last Chance to Save up to $400 is This Friday, October 9th
Register Today
Be Sure to use code: D15172BLOG

  

Connect with hundreds of your colleagues this December in San Diego at the largest and most trusted Antibody Engineering & Therapeutics event to discover, engineer and develop novel and next generation antibody modalities across diverse disease indications. Included with your 4-day registration fee this year is a new 2-day Antibody-Drug Conjugate track that will showcase the latest progress and clinical updates from the most exciting ADC programs in development.

Secure your seat today to attend this year's meeting and access:
• 100+ speaker presentations covering critical scientific and development updates that can accelerate your antibody research, discovery efforts and clinical programs - download the agenda. 
• 50+ exhibitors to keep you on the pulse of evolving technologies
• 100+ scientific posters to give you first-hand updates on unpublished, peer-submitted research projects
• 700+ global antibody researchers for you to connect with onsite to forge successful scientific and business partnerships

A sample of the attending companies:
• Abbvie
• Albert Einstein College of Medicine
• Amgen
• Bayer Healthcare
• Biogen
• Boehringer Ingelheim
• Boston College
• Boston University
• Bramhill Biological Consulting
• Bristol Myers Squibb
• Celgene Corporation
• Covagen AG
• Daiichi Sankyo
• Dana Farber Cancer Institute
• Dartmouth College
• David Geffen School of Medicine at UCLA
• Development Center for Biotechnology
• Eli Lilly & Company
• EnGen Bio
• Esbatech A Novartis Company
• Genentech
• Genesun Biopharmaceutical      
• Genmab BV
• Genomics Inst of Novartis Research
• Genzyme Corporation
• Georgetown University
• GlaxoSmithKline
• Global Biological Standards Institute
• Imaginab
• Immunocore
• ImmunoGen
• Janssen
• Johnson & Johnson
• Jounce Therapeutics
• Kookmin University
• KTH Royal Institute of Technology
• Massachusetts Institute of Technology
• Maxcyte Inc
• MD Anderson Cancer Center
• MedImmune
• Meditope Biosciences
• Memorial Sloan Kettering Cancer Center
• Merck
• Merrimack Pharmaceuticals Inc
• National Cancer Center Hospital East
• National Cancer Institute NIH
• National Institute for Communicable Diseases
• National Research Council Canada
• Novartis
• Novo Nordisk   
• OMT Therapeutics
• Oslo University Hospital, Rikshospi
• Oxford University Kellogg College
• Panorama Research Institute
• Pfizer
• Queen Mary University of London
• Regeneron
• Research Corporation Technologies
• Roche
• Royal Institute of Technology (KTH)
• Sanofi
• Seattle Genetics
• Simon Fraser University
• Stanford University Medical Center
• Stanford University School of Medicine
• Taipei Medical University
• Takeda
• Tel Aviv University
• Teva Pharmaceuticals
• The Rockefeller University
• The Scripps Research Institute
• The University Of Tokyo
• Tokyo University of Pharmacy and Life Sciences• UCL Cancer Institute
• UMass Medical School
• Univ. of Texas MD Anderson Cancer Ct
• University of Cincinnati College of Medicine
• University of Pittsburgh Cancer Institute
• Vaccinex
• Yale School of Medicine and more!

Don't miss out! Join the growing list of attendees at the largest antibody engineering and therapeutics event in the industry! This Friday, October 9th is your last chance to take advantage of the early-bird savings of up to $400. Be sure to use code: D15172BLOG – Register here.

Best,
The Antibody & Protein Therapeutics – From Discovery to Production Team
@ibcusa
#AntibodyEng
http://futurebiopharma.blogspot.com/

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New Development in Monoclonal Antibodies!

A recent development in monoclonal antibodies for Alzheimer's was announced in an article by FierceBiotech Research. Scientists at NYU Langone Medical Center's Center for Cognitive Neurology is conducting a study that suggests monoclonal antibodies designed to specifically target misfolding proteins in soluble, aggregated states, could be ideally used to treat neurodegenerative diseases such as Alzheimer's, ALS, Parkinson's, and Huntington's.

Monoclonal antibodies are now used for treatments of a wide array of diseases, especially cancer, autoimmune, and inflammatory diseases and the studies are only expanding. With the market for monoclonal antibodies exploding to an estimated $31.7 billion by 2017, don’t miss out on the opportunity to discover the future of antibody engineering at the upcoming IBC’s Antibody Engineering & Therapeutics event.

This is the most trusted antibody engineering event in the industry where you will not only connect with over 700 antibody industry experts, but also learn about the latest antibody science and applications to expand your pipeline of antibody therapeutics.

Hear from the below experts this December 7-10  in San Diego, CA to uncover more about monoclonal antibodies and recent developments for non-cancer and orphan indications.

• Trudi Veldman, Ph.D.., Senior Director Biologics Generation, AbbVie Bioresearch Center
• Patrik Maurer, Ph.D., Head Research and Preclinical Development, ESBATech, a Novartis Company, Switzerland
• Jos Raats, Ph.D., CEO, ModiQuest B.V., The Netherlands
• Mary Keir, Ph.D., Scientist, Immunology, Tissue Growth and Repair (ITGR), Diagnostic Discovery, Genentech, Inc.
• Ahuva Nissim, Ph.D., Reader in Antibody and Therapeutic Engineering, Biochemical Pharmacology, Queen Mary University, United Kingdom
• Ulrich Wuellner, Ph.D., Associate Director, Discovery Research, Covagen AG, Switzerland
• Chung-Ming Hsieh, D.SC., Associate Director, Biologics, AbbVie Bioresearch Center
• James Larrick, M.D., Ph.D., Managing Director and Chief Medical Officer, Panorama Research Institute and Velocity Pharmaceutical Development
• Bo Yu, Ph.D., Co-founder and CSO, Larix Bioscience, LLC
• Wendy Williams Ph.D., Scientist II, Antibody Discovery and Protein Engineering, MedImmune, United Kingdom
• Vaughn Smider, M.D., Ph.D., Assistant Professor, Department of Cell and Molecular Biology, The Scripps Research Institute
• Mark De Boer, Ph.D., CEO, Fast Forward Pharmaceuticals BV, The Netherlands
• Peter Ulrichts, Ph.D., Principal Scientist, arGEN-X BVBA, Belgium

Download the Brochure for the Full Session and Speaker Details.

Accelerate your antibody research, discovery efforts and clinical programs at the most comprehensive event for comparing and contrasting engineering, discovery and development strategies for different antibody modalities.

Plus, take advantage of an extra $100 off the current rate with code D15172BLOG - Register Now!

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How to successfully integrate continuous capture with perfusion bioreactors

In a previous post I described the drivers for, and, benefits from, the trend towards the continuousproduction of biopharmaceutical drugs in which I referenced the article of Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of RecombinantTherapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Amongst Veena’s contributing authors is Konstantin Konstantinov a key contributor to the literature on continuous bioprocessing and Keynote speaker at the Bioprocess International 2015 Conference with a presentation entitled “What is the Future of Continuous Processing  – What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?"

Extending continuous processing downstream to include the capture step

A key concept that the team from Genzyme developed is the integration of continuous chromatography with a perfusion bioreactor for the production of both high volume and stable monoclonal antibodies and low volume, less stable recombinant human enzymes. A 12 L bioreactor was operated for up to 70 days by utilizing the Alternating Tangential Flow (ATF) cell retention technology. The ATF permeate that was harvest was loaded directly onto a periodic counter current (PCC) chromatography system. Systems such as these are now available from a variety of suppliers including GE Healthcare, Pall, Semba and NovaSep. Genzyme were able to operate the PCC system in a fully closed and sterile state for a prolonged period of time.

The benefits of integrating continuous culture with continuous capture

Adopting this approach can lead to significant benefits because of the high cell densities and volumetric productivities that can be achieved. This allows significantly smaller bioreactors to be used thereby reducing facility size and capital costs. The ATF system eliminated the need for a more complex harvesting system, however, integration with PCC eliminated the need for large hold tanks, a non-value adding operation, and allowed the capture column to be reduced by a minimum of two-fold.

Improved product quality of less stable proteins

Integration of upstream and downstream operations in this way allows for the continuous flow of product from the bioreactor, through the capture step and into the chromatography eluate and mitigates the risk of product degradation of less stable proteins.

Though the issue of stability may be less of a concern for monoclonal antibodies, the team have created a platform capable of delivering a range of biopharmaceuticals from within a single facility.

What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?

How would you answer this question? Do you think the industry will see this within 5 years? 10 years? 20 years? Or more?

Dr Nick Hutchinson

Join me at #BPIconf

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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The continuous production of biopharmaceutical drugs

If there is one hot topic in biomanufacturing at this moment in time it has to be continuous processing. Journals and websites are feeding, what appears to be, the biopharmaceutical industry’s almost insatiable appetite for information on the subject. The interest is reflected in the deals made within the industry such as Pall Corporation's acquisition of the BioSMB technology platform from Tarpon Biosystems and Repligen Corporation’s 2014 acquisition of Refine Technology. Refine developed and manufactured the Alternating Tangential Flow (ATF) filtration device which can be used to retain mammalian cells within bioreactors while continuously harvesting product.

With such a focus within biopharma upon continuous processing it is no surprise that a significant portion of the Bioprocess International 2015 Conference, agenda is allocated to talks on this subject. Before we look at some of those talks in more detail, however, we should review the industry drivers that appear to be taking the bioprocess sector away from the batch process paradigm and moving it towards a continuous manufacturing future.

The four key industry drivers behind continuous bioprocessing

In an excellent article, Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of Recombinant Therapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Four key drivers are given as:

1.    the need for biopharma companies to flexibly accommodate large-volume and orphan drugs potentially within the same facility

2.    the need for production platforms to accommodate both stable monoclonal antibody and less stable recombinant protein therapeutics

3.    the need to make rapid adjustments in production capacity in line with the dynamics of market demand

4.    increasing cost pressures, not least, due to the growing pipeline of biosimilars in development

The benefits of bioprocess intensification

Warikoo and her co-authors explain that the conversion for batch to continuous manufacturing has occurred in many other industries in the past and has led to the following benefits:

1.    steady-state operation

2.    small equipment size

3.    high volumetric productivity

4.    streamlined process flows

5.    low cycle times

6.    reduced capital costs

Too conservative for continuous?

Bioproduction is renowned for being a conservative endeavour. Despite the business deals and industry drivers are we really ready for continuous biomanufacturing or is the noise in the media simply empty hyperbole? Will continuous processing become the rule or remain the exception? Join the debate by letting us know your thoughts.

 

Dr Nick Hutchinson

Join me at #BPIconf

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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Recommendations for Cell Banks Used in GXP Assays: Preparation, Characterization, and Storage

Today, we take a look Recommendations for Cell Banks Used in GXP Assays according to Ana T. Menendez, Nadine Ritter, Jonathan Zmuda, Darshana Jani, and Jaya Goyal.   This appeared in a recent issue of BioProcess International.

Special Report: Recommendations for Cell Banks Used in GXP Assay

Cells and cell-derived reagents form the basis of an operationally challenging class of test methods used in execution of product potency testing (stability and lot release), assessments of pharmacokinetic/pharmacodynamic (PK/PD) profiles, detection of antidrug antibodies (ADAs) or neutralizing antibodies (NAB), and characterization and comparability testing of biopharmaceutical products. Frequently, cell-based assays provide the only measurement of the tertiary/quaternary structure of each batch of product at the time of lot release and during stability testing to assist in determining product shelf-life. Cultured cells themselves are often used to generate monoclonal antibodies (MAbs), enzymes, or substrates for use as critical reagents in other types of tests, including ligand binding and enzymatic assays. In all these applications, the cells serve as highly critical, highly complex “reagents” that require distinct characterization and control measures to ensure operational consistency over time.

Cells are sensitive to innumerable chemical and physical elements that can alter expression of their cellular proteome and change growth characteristics or responsiveness to ligands/biopharmaceuticals. Establishment and characterization of homogeneous, stable cell banks are necessary to ensure that starting cellular material for each assay is as consistent as possible. Appropriately established and stored master and working cell banks (MCBs and WCBs) provide a continuous supply of viable cells to generate accurate, reliable results within specified test methods or provide the cell-derived reagents used in those methods.

Although the strategy for preparing cell banks is clearly defined by regulators for cells used to produce biotechnology products, it is less clear what strategies should be applied to cells that are used solely as part of analytical or bioanalytical test methods. An early FDA points-to-consider (PTC) guidance on characterization of cell lines for producing biologicals (1) outlined many MCB and WCB characterization requirements that were later adopted into ICH Q5D for production cell lines (2). But it is still common to find the phrase PTC testing used in relation to the list of tests applied to nonproduction cell banks even though that guidance was not intended to apply to such banks.

In the absence of clarifying information about the significant differences in intended use between production cell lines and those used for analytical/bioanalytical methods, some laboratories choose to apply the entirety of the PTC guidance to both. Conversely, others fail to establish cell banks at all for analytical use, severely jeopardizing the desired state of assay control. The US Pharmacopeia recently published a suite of chapters — <1032> Development (3), <1033> Validation (4), and <1034> Assay Analysis (5) — providing guidance on good manufacturing practice (GMP) potency bioassays. Several paragraphs in USP <1032> provide a general outline for MCB and WCB preparation; however, specific details are not provided to assist laboratories with the less obvious but still critical aspects of creating, characterizing, and storing MCBs and WCBs.

Recommendations presented herein support and significantly elaborate on principles noted in USP <1032> for establishment and characterization of mammalian and bacterial cell banks used to support analytical/bioanalytical testing. These approaches may also be extrapolated (when applicable) to include cells used for reagent production, for growing viruses used in test methods, and so on. These strategies represent our combined opinions on best practices in establishment, characterization, and maintenance of controlled and consistent cell sources using a risk-based and product-phase–appropriate approach. Each sponsor should determine which recommendations to adopt and when each will be performed based on the level of risk acceptable in developing and validating methods that use cells or cell-derived reagents.



References
(1) CBER. Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products. US Food and Drug Administration: Rockville, MD, 1993; www.fda.gov/downloads/biologicsbloodvaccines/safetyavailability/ucm162863.pdf.
(2) ICH Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. US. Fed. Reg. 63(182) 1998: 50244–50249
(3) USP <1032> Development and Design of Biological Assays. Pharmacop. Forum 36(4) 2010: 956.
(4) USP <1033> Validation of Biological Assays. Pharmacop. Forum 36(4) 2010: 986.
(5) USP <1034> Analysis of Biological Assays. Pharmacop. Forum 36(4) 2010: 1005.

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Single Use Session Spotlight: Single-Use Process Fit for mAb Production

Applying single-use technology has shown to lower costs and increase yield. How? Merck & Co., Inc. completed an end-to-end process fit using single-used technology for the production of monoclonal antibodies. Gain insights on single-use technology versus traditional stainless steel for process fits and facility designs. Dr. Jeffrey Johnson will be joining us at the Single-Use Applications Summit for Biopharmaceutical Manufacturing to present Single-Use Process Fit for mAb Production this June in Durham, North Carolina.

For more information on this session and the rest of the program, download the agenda. If you'd like to join us June 3-5, 2013, in Durham, North Carolina, as a reader of this blog when you register to join us and mention code SU13JP, you'll save 20% off the standard rate!

Featured Session:  Single-Use Process Fit for mAb Production

Featured Speaker: Jeffrey Johnson, MS, New Technology Lead, Merck & Co

About the session: A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.

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