Hanns-Christian Mahler (head of drug product services, Lonza), BPI Theater @ BIO, June 8, 2016 11:20–11:40 am A drug product transfers a biomolecule (drug substance) into a form that will be usable by patients. It contains the active ingredient with excipients and can include packaging or a device for administration. In many cases, patients must be able to administer drugs to themselves. “Think about how the drug will be administered before designing your formulation,” Mahler suggested. Keeping a biomolecule intact…

Greg Adams (director of analytical and formulation development, FUJIFILM Diosynth Biotechnologies), BPI Theater @ BIO, June 8, 2016 11:40 am –12:00 pm Fujifilm Diosynth Biotechnologies is a global contract development and manufacturing organization (CDMO) that has worked on multiple molecules. Adams said that proteins are complicated molecules with three dimensional (3-D) structures (primary, secondary, and tertiary) that are apt to self-aggregate. Monoclonal antibodies (MAbs), which we think of as relatively simple proteins, actually have very complex 3-D structures, with multiple…

Michael Merges (director of Catalent Biologics), BPI Theater @ BIO, June 8, 2016, 1:40–2:00 pm Many small companies do not have the expertise or specialized technologies to do the necessary testing that underlies biologics manufacturing. Expertise is needed in microbiology, raw materials testing, characterization, and method development. At the same time, testing is taking place earlier in product development. Bioassays are the most outsourced service, and that is expected to continue. Catalent has over 25 years of experience in characterizing…

Greg Beattie (corporate vice president for global insourcing solutions and research support services, Charles River Laboratories), BPI Theater @ BIO June 8, 2016, 2:00–2:20 pm When you think of Charles River Laboratories,” Beattie began by asking, “do you associate it with anything other than rodents?” The company is very well known for selling rats and mice. However, it is also one of the world’s largest outsourcers in the biological testing field. The company is also one of the largest “insourcing”…