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Emerging Bio-Therapies and Their Manufacturing Challenges – BIO 2016

Friday May 20, 2016

Patricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc. will lead a panel discussion entitled, Emerging Bio-Therapies and Their Manufacturing Challenges at the BioProcess Intl, BioProcess Theater at BIO 2016 June 6-9 in San Francisco, CA. Panel experts will focus on the emerging therapies using cell and gene therapy, drug conjugates, bispecific antibodies and others, and the unique manufacturing challenges these therapies present. The panel will cover:

  • Process development and manufacturability of these therapies
  • Access to manufacturing facilities for these therapies – outsource or build
  • 20/20 – how prevalent will these therapies be by 2020 and beyond, and will industry be able to meet the demand

Please stop at the BPTC booth #6267 while at BIO 2016.

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BIO International Convention 2016

Wednesday May 11, 2016

Title: BIO International Convention 2016
Location: San Francisco, CA.
Description: Join BPTC at the annual BIO International Convention 2016 in beautiful San Francisco, CA from June 6-9, 2016 to exchange ideas and insights on biotech’s most relevant and timely topics with the industry’s thought-leaders. Patti Seymour  (pseymouratbptcdotcom)  , Senior Consultant and supply chain expert, will be making a presentation entitled, “The Changing Landscape for Biomanufacturing: Product Strategies, Market Environment, and Biomanufacturing Dynamics” on Monday, June 6th at 1:00 p.m. in Room West 3008. While you are at BIO, stop by booth #6267 to meet with our subject matter experts and explore how we can support the technical, strategic, and regulatory aspects of your biopharmaceutical development programs.

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2016 Progress in Continuous Biomanufacturing Conference

Friday May 6, 2016

BPTC’s Tom Ransohoff, Vice President and Principal Consultant, will be presenting at the World Biopharm Forum
2016: Progress in Continuous Biomanufacturing to be held in
Cambridge, U.K. on Jun 27-28, 2016. Mr. Ransohoff’s presentation will
be titled “Opportunities for Continuous Manufacturing in the
Production of Biopharmaceuticals” and will review areas where
continuous manufacturing may be deployed as the approach continues
to make inroads in the biopharmaceutical field.

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Time is Money: Reducing the biopharmaceutical discovery and development timeline by 60%

Friday May 6, 2016

In today’s competitive market, companies do not have time to develop new biopharmaceuticals using a linear path strategy. Overlapping late stage discovery activities and early stage development is an emerging approach that provides risk reduction while accelerating timelines. In her recent presentation, Multiplexing for Efficient Product Development, BPTC’s Susan Dana Jones, Ph.D., Vice President and Principle Consultant  (sjonesatbptcdotcom)  , provided two case studies demonstrating how this strategy benefits companies, investors, and patients. The outcomes are superior biopharmaceutical candidates that lend themselves to easier manufacturing strategies, and shorter timelines to first-in-human studies.

This shift away from a linear pathway is made possible by the evolution of development tools. These advancements include improvements in:

· Expression technologies

· Robust host CHO cell lines

· Rapid clone screening methods

· Instrumented micro-bioreactors

· High throughput analytics/robotics

· Single use technologies

Taken together, developments in expression and purification technologies, miniaturization of process unit operations, robotics and automated analytics have contributed to reducing timelines and risk when developing an initial manufacturing process. The employment of these technologies allows the multiplexing of overlapping discovery and development activities, thus allowing what was once a linear development path to evolve into an integrate approach reducing the discovery and development timeline from 2 ½ years to 18 months.

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Protein A: Extending this Platform Process Paradigm

Friday Apr 15, 2016

by: Frank Riske, Ph.D.  (friskeatbptcdotcom)  

The use of affinity resins for recombinant protein purification has the potential to revolutionize downstream manufacturing processes. Such platform processes, based around affinity chromatography, will accomplish what Protein-A (PA) resin has done for monoclonal antibody therapeutics (MAb’s), a $85 billion market. For non-MAb recombinant proteins the use of affinity approaches will substantially reduce process development time and bring new products to market more quickly. Although a unique affinity resin will likely be needed for each protein of interest, the benefits of affinity resin development will outweigh the development requirements of time and cost.

Protein A works because IgG monoclonal antibodies have similar Fc regions, which bind to a specific Protein A domain. Non-antibody therapeutic proteins do not share common binding regions. The challenge becomes identifying a specific affinity ligand around which to develop a capture resin. Such a unique affinity ligand/resin system, one that binds the target with nM to pM affinity, can often yield a highly pure target protein with high recovery. The ligand should specifically bind the target in culture broth or other crude post-upstream streams and release the target under conditions that maintain the target protein’s biological activity.

What would the process look like? An additional two to three columns would likely be used to polish the target material post the affinity capture column. The second column, in a bind elute mode, would be specific for removing the major impurity(s) in the product, such as aggregates, fragments, or improperly glycosylated or phosphate forms, etc. The third column, in a flow through mode, might be an anion membrane used to reduce residual materials such as DNA, endotoxin (if from E. coli culture) and host cell proteins.

Affinity ligands include affimers, aptamers, peptides, dyes and other small molecules. The discovery and initial development of any of these ligands can take several months and producing a custom commercial resin will take additional time. An approach, to reduce the development and implementation time, would involve applying rational design, and/or high throughput screening, during the research phase when the therapeutic protein is being characterized. The ligand identification would be completed as efficacy is determined in the appropriate animal model. The purpose would be to obtain an appropriate ligand (in-house or external) for Phase I downstream development. Small batches of resin from the resin manufacturer would be used to develop the process. At the completion of process development sufficient affinity resin would be available from the resin vendor for early clinical studies. The ability to produce commercial lots would be established during Phase II. A well established, large scale, resin manufacturer would be charged with developing a robust reproducible manufacturing process at the appropriate scale for the client’s needs and to keep sufficient inventory at hand.

The use of affinity chromatography simplifies development and condenses the development timeline for commercial implementation. Combining affinity capture with scaling- out (adding a second production line when additional commercial capacity is needed) should simplify facility design as well.

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