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Two-Day Training Course: Introduction to Biopharmaceutical Manufacturing

Thursday Oct 1, 2015

Drs. Sheila G. Magil, Senior Consultant, and Frank Riske, Senior Consultant, will be leading a training course entitled, Introduction to Biopharmaceutical Manufacturing, during at the annual BioProcess International Conference and Exhibition to be held at the Hynes Convention Center in Boston, MA from October 26-27, 2015. For more information about this course or other BPTC training programs, please contact Al Doig  (adoigatbptcdotcom)  .


11 New Monoclonal Antibodies in Regulatory Review Spells Bright Future Ahead

Thursday Sep 17, 2015

By Al Doig  (adoigatbptcdotcom)  

Since the approval of Orthoclone OKT3 in 1986, the therapeutic monoclonal antibody industry has experienced three decades of continuous growth. Today there are over 40 market approved MAb products in the US and EU, having combined sales of over $75 billion in 2013. Our recent article entitled Monoclonal Antibody Targets and Indications, identifies three important industry trends based on an analysis of a bioTRAK® dataset. First, a number of the products currently in late stage development are focused on novel targets suggesting that the number of indications that will be successfully treated with MAb therapeutics is likely to grow. Second, several late stage development programs are focusing on developing improved antibody products against known molecular targets. These programs may yield “biobetters” for indications such as asthma, leukemia, non-small cell lung cancer, and multiple sclerosis. Third, there are 24 biosimilar development programs chasing the blockbuster revenue streams of six established innovator products.

As of July 1, 2015, there were 11 new MAb products under regulatory review for market approval either in the US and/or EU. In addition, two biosimilars have MAA applications under review; one a biosimilar to etanercept (Enbrel), and the other a biosimilar to infliximab (Remicade). Another 22 biosimilars are in Phase 3 development suggesting a competitive marketplace just over the horizon. An analysis of 62 MAb products in Phase 3 development finds autoimmune diseases and cancer to be the indication areas receiving the most development attention. However, approximately 1/4 of the MAbs in Phase 3 are for the treatment of indications outside these areas and include cardiovascular, neurological, and orthopedic diseases for which no approved MAb products currently exist.

MAbs as therapeutic agents continue to be viewed as attractive platforms for new drug development by industry. As the biopharmaceutical industry continues to grow, the number of molecular targets and therapeutic indications that can be treated with MAb products will undoubtedly increase. Many products that are currently in late stage development are focused on novel targets, confirming that the number of indications that will be treated successfully with MAb therapeutics in the future will be larger than today. In addition to antibodies in development against novel targets, several late stage development programs focus on developing improved antibody products against known molecular targets and these programs may yield “biobetters” for indications such as asthma, leukemia, non-small cell lung cancer, and multiple sclerosis. The result of both of these important trends –growth in indication areas treated by MAbs and growth of biosimilars – is likely to be an increase in the demand for manufacturing capacity to produce monoclonal antibodies.


Cell Therapy BioProcessing and Commercialization

Tuesday Sep 15, 2015

David Broad, Ph.D., Senior Consultant, will be attending IBC’s Cell Therapy BioProcessing and Commercialization conference to be held in Alexandria, VA from September 30 – October 2, 2015. Dr. Broad looks forward to networking with colleagues and learning more about the latest innovations to overcome the significant technical challenges faced by cell therapy companies. To pre-arrange a meeting at the conference, please email David  (dbroadatbptcdotcom)  .  Check out our latest blog about CAR-T therapies here.


Supercharged T-Cells Battle Cancer But Will GxP Compliance Be Their Kryptonite?

Tuesday Sep 8, 2015

By Sheila G. Magil  (smagilatbptcdotcom)  

What if your company had to sign off on hundreds of unique product batch releases a year; each a therapeutic for a specific individual, and where a “mix-up” could be fatal? This is the challenge facing developers of chimeric antigen receptor T-cell (CAR-T) therapeutics and other autologous cell therapies.

Results of clinical trials for CAR-T leukemia treatments have shown stunning outcomes. In a trial at Children’s Hospital of Philadelphia 27 of 30 pediatric patients had a complete remission of their cancers. Similarly, in the Memorial Sloan-Kettering Cancer Center Trial, 14 of 20 adult patients experienced comparable remission results and even more early phase trials have reported similar outcomes. Using the CAR-T approach each patient receives his or her own modified T cells as the active therapeutic agent. The commercialization hurdle for this therapy and other autologous cell therapies is creating a GxP compliant cell culture system for every patient. This unprecedented situation presents a number of unique analytical challenges for our industry:

  • T-cells harvested from each patient represent a unique “production cell bank” that must be fully characterized;
  • Robust bioassays are required to evaluate the health and potency of transfection appropriate T-cells; and
  • Cell stability assays will be required to monitor, as with any cell bank, the frozen and stored expanded cells of each donor master cell bank (MCB).

Despite these and other commercialization challenges, CAR-T technology continues to attract the attention of venture capitalists and big pharma. Several partnerships around CAR-T therapies have been announced, including Immunocore’s agreements with AstraZeneca, Hoffmann La Roche (Genentech), and Eli Lilly, Juno Therapeutics’ 10-year collaboration with Celgene, Kite Pharma’s agreement with Amgen, and Pfizer’s investment in Cellectis. Novartis announced the intent to establish a cGMP CAR-T manufacturing facility under its partnership with the University of Pennsylvania. And just recently, Sorrento Therapeutics announced that its subsidiary, TNK Therapeutics, had acquired preclinical and clinical stage CAR-T programs and associated technology from two privately held companies.

Clearly, the promising early clinical outcomes are driving the flurry of ventures between the CAR-T technology innovators and big pharma. However, many process and regulatory hurdles lay ahead before the CAR-T approach becomes a standard of care in cancer treatment. Bringing these therapeutics to the market will require cooperation between industry and regulators as new methods and processes are developed to overcome the unique challenges for this class of therapeutics.


14th Annual Contract Pharma Conference and Exhibition

Monday Sep 7, 2015

Based on current data from BPTC’s proprietary bioTRAK database, Dawn M. Ecker, Consultant, will be delivering a presentation on, “The Potential Impact of Biosimilars on Biomanufacturing Capacity” at the 14th Annual Contract Pharma Conference and Exhibition to be held on September 17-18, 2015. To schedule a meeting at the conference to learn how we can support your biosimilar development and outsourcing requirements, please email Dawn  (deckeratbptcdotcom)  .