BPI Theater

Challenges in the Development of Biologic Drug Products

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…

The Portrait of a Protein: Exposing Its Character with Advanced Analytics

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…

Benefits to Strategic Outsourcing of Biologics Analytical Studies

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…

Insourcing, Outsourcing, and Everything in Between: Tough Questions, Real Answers, and How to Make the Correct Decision for Your Situation

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”…

Making the Correct Outsourcing Decisions

A BPI Theater Roundtable at the 2016 BIO Convention On Wednesday, 8 June 2016, Gil Roth (president of the Pharma and Biopharma Outsourcing Association, PBOA) chaired a lunchtime roundtable titled, “Making the Correct Outsourcing Decisions.” He brought together a panel of four experts: Cory Lewis (vice president of business development and marketing at Cook Pharmica) Andrew Sanford (vice president of global business development for biologics at Catalent) David Powell (Pfizer CentreOne) Rajan Puri (senior director of business development at Therapure…

On-Demand Product Development Teams

A BPI Theater Roundtable at the 2016 BIO Convention On Wednesday, 8 June 2016, Joshua Speidel (managing director of the commercial practice team at the Latham Biopharm Group) chaired an afternoon roundtable titled, “On- Demand Product Development Teams.” He brought together a panel of four experts: Matt Rebold (director of business development at ICON Imaging and Technology — West Coast) Paul Jojorian (global head of technology transfer for Patheon Biologics) Eiry Wyn Roberts (vice president of research and development for…

Downstream Processing – Interview with Pete Gagnon

BioProcess International editor in chief Anne Montgomery spoke with Pete Gagnon, Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore, at the BioProcess International Conference and Exposition in Boston, MA, October 2015. Sponsored by Click here to view the other videos in this series.

Downstream Processing – Interview with Giorgio Carta

BioProcess International editor in chief, Anne Montgomery, interviewed Giorgio Carta, Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia at the BioProcess International Conference and Exposition in Boston, MA, in October 2015. Sponsored by Click here to view the other videos in this series.

Downstream Processing – Interview with Dr. Carsten Voß

BioProcess International editor in chief Anne Montgomery spoke with Dr. Carsten Voß, application specialist, Process Chromatography, Bio-Rad Laboratories GmbH at the BioProcess International Conference and Exposition in Boston, MA, October 2015. Sponsored by Click here to view the other videos in this series.