Thursday, July 11, 2019 Daily Archives

Biopharmaceutical Indications and Targets: Past, Present, and Future

Dawn M. Ecker, consultant and bioTRAK database manager, BioProcess Technology Group Over the past 15 years, the BioProcess Technology Group (BPTG, formerly BioProcess Technology Consultants) has built and maintained the proprietary internal bioTRAK database to track recombinant biopharmaceutical products from preclinical development through US and EU commercialization. In addition, the firm is watching other biopharmaceutical markets, including for gene therapies and modified cell therapies. BPTG also is considering regional products for regional markets and tracking manufacturing capacity required to manufacture…

CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines

Courtney Morgret, senior scientist, AbbVie Morgret’s presentation focused on antibody–drug conjugate (ADC) manufacturing and ways to accelerate it. She pointed out that ADCs have the potential to be filed for market approval based on phase 2 data. A few such products have been approved and are on the market today, with many more in the pipeline. ADCs provide an opportunity to address unmet medical needs. The task of a CMC (chemistry manufacturing and controls) group is to move a product…

Single-Use Technology for Containment During ADC Handling

Scott Patterson, vice president of commercial sales, ILC Dover Antibody–drug conjugates (ADCs) are increasing in popularity, with a robust pipeline that could lead to a US$10-billion market over the next several years. These novel treatments combine the high potency of small molecules with the targeting ability of monoclonal antibodies (MAbs). However, the challenge of such treatments is that they combine a highly potent, toxic material with a large protein that will target a treatment area. As a result, manufacturing the…