BPI Theater

Where Are Today’s Biomanufacturing Bottlenecks and How Is Industry Looking to Overcome Them?

Moderator Dan Stanton, with Ramon LeDoux (YMC Process Technologies), Courtney Morgret (AbbVie), and Kiran Chin (MKA Insights) Moderator Dan Stanton began the discussion by talking about bottlenecks within manufacturing. “The term bottleneck brings up imagery that describes the sort of problems we have when it comes to the manufacturing flow,” he stated. He posed the first question to Kiran Chin: “Your presentation highlighted companies that ask the right questions, and you spoke of the importance of doing so when it…

At What Point in Drug Development Must a Firm Look to Process Optimization, and How Critical is this Timing to a Product’s Overall Success? A Roundtable Discussion

Moderator Dan Stanton, with Kelsey Achenbach (Roquette), Andy Davies (Prometic Bioseparations), and Eric Langer (BioPlan Associates) Dan Stanton initiated the final roundtable of the 2019 BPI Theater at CPhI by asking panelists about process optimization. “Why has it entered the mainstream of parlance within the biopharmaceutical industry?”   Achenbach defined process optimization as anything that improves a process, typically from a cost perspective. The term interests many people in the industry now because it is at a stage where such…

Biopharma as a Maturing Industry: Raw Material Selection as a Means of Process Optimization

Kelsey Achenbach, head of pharmaceuticals marketing, Roquette Roquette is a family-owned French company with more than 20 manufacturing facilities and a presence in more than 100 countries. For small-molecule pharmaceuticals, it offers a broad range of excipients; for large molecules, it offers ingredients both for cell culture and protein stabilization. The company has more than 300 people in its R&D workforce who focus on understanding the science behind their materials. Achenbach’s goal was to initiate a conversation between raw material…

Reducing Risk and Improving Timelines in the Design, Development, and Manufacture of Antibody Drug Conjugates

Juan Cordova, principal scientist in bioconjugation, Abzena Cordova began his presentation by introducing Abzena as a global network that provides an integrated solution for the development and manufacture of biotherapies, including antibody–drug conjugates (ADCs). The company operates three different facilities, in which it develops and manufactures complex small molecules as well as bioconjugate therapies. ADCs are one of the most complex examples of biotherapies approved by the US Food and Drug Administration (FDA) on the market today because they comprise…

China’s Focus on Innovation: Investment in Product and Process Development — Innovative Technologies from China Are Coming

Eric Langer, managing partner, BioPlan Associates China is a probable center of concentration for the next generation of biotechnology. However, Langer believes that the country will fail in its goal of achieving that if it cannot innovate. He said that forecasters need to understand the complex elements associated with development of biotechnology centers other than those for biogenerics and biosimilars. How is China going to develop the necessary innovation capability? Driving the industry are the 7,500 cancer deaths every day…

Flow-Through Polishing and the Use of Multimode Ligand Libraries to Improve Process Efficiencies

Andy Davies, sales and marketing director, Prometic Bioseparations Davies began his presentation with a few words about his company, which for the past 30 years has provided a range of bioseparations products, including off-the-shelf and bespoke solutions. Prometic Bioseparations recently launched a number of semidisposable and disposable, prepacked, GMP-ready columns. The latest launch is a multimode mimetic (MMM) ligand library, which was the focus of his talk. Among a range of technologies, the least resolving technique is gel filtration, which…

Scaling Multi-Column Chromatography to the Production Suite

Ramon LeDoux, senior business development manager, YMC Process Technologies LeDoux focused his presentation on downstream bioprocess techniques, specifically scaling up multicolumn processes. Relatively new advances in twin-column technology have brought significant increases in productivity over the past several years. That led YMC Process Technologies to adopt a twin-column approach. A challenge with traditional chromatography has been to balance purity, throughput, and recovery. “If purity is your standard,” LeDoux stated, then “typically if you want high recoveries, your throughput suffers. Overloading…

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…