Scott A. Miller, senior scientific advisor, Carbogen Amcis AG Miller provided an overview of bioconjugation followed by a brief discussion of the project management aspects of this highly complex process. Developing and manufacturing antibody–drug conjufgtes (ADCs) is complicated, so it’s important to understand how to manage the processes involved. Some general considerations for developing ADCs include understanding the current phase of a project, the number and status of analytical methods required, the scale of conjugation, the sourcing of both antibody…

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…

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…

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…

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…

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…

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…

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…