Author Archives: Alison Center

Panel Discussion: Emerging Biotherapies and Their Manufacturing Challenges

At noon on Tuesday, 20 June 2017, BioProcess International presented a panel discussion as part of the “Emerging Therapies” session of its BPI Theater at the Biotechnology Innovation Organization’s annual convention in San Diego. Moderated by Patricia Seymour (senior consultant at BioProcess Technology Consultants), this panel comprised Holger Wesche (vice president of research at Harpoon Therapeutics), Richard Snyder (chief scientific officer of Brammer Bio), Marc Better (vice president of product sciences at Kite Pharma), and Paulo Carvalho (associate director of…

Panel Discussion: How CMO Business Models Have Adapted to Meet the Challenges and Opportunities of Protein-Based and Emerging Therapy Markets

On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 1:20 to 2:00 pm as part of the “Emerging Therapies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Gil Roth (president of the Pharma and Biopharma Outsourcing Association), the panel comprised John Foy (vice president of business management for biologics at Patheon), Michael A. Riley (vice president and general manager of Catalent Biologics), Victor Vinci (vice president and chief scientific officer…

Panel Discussion: Cell, Gene, and Tissue Therapies — Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 2:20 to 3:30 pm as part of the “Emerging Therapies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by David Brindley (University of Oxford and Harvard University), the panel comprised Morrie Ruffin (managing partner of the Alliance for Regenerative Medicine), David Backer (head of commercial development for gene editing and novel modalities at MilliporeSigma), Robert Preti (president and chief executive officer of…

Panel Discussion: Process and Business Considerations for Innovation — Supplier and End-User Perspectives

On Wednesday, 21 June 2017, BioProcess International presented a panel discussion from 11:00 am to 12:00 pm as part of the “Emerging Techniques and Technologies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Tom Ransohoff (vice president of BioProcess Technology Consultants), the panel comprised Stewart McNaull (senior vice president of business development at KBI Biopharma), Bernard Huyghe (senior director at Pfizer), John Bonham-Carter (director at Repligen, not pictured), and Todd J. Menkhaus (cofounder of…

Panel Discussion: Single-Use and Process Development Technologies — Making the Right Choices for Your Process

At noon on Wednesday, 21 June 2017, BioProcess International presented a panel discussion as part of the “Emerging Techniques and Technologies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Susan Dexter (managing director of Latham Biopharm Group), this panel comprised Deborah Harris (vice president of operations at Abzena), Magnus Schroeder (director of downstream process development at CMC Biologics), and Stephen Lam (vice president of operations at Patheon). There is no debate: Single-use technologies…

Panel Discussion: How to Differentiate Your Vaccine Platform in a Competitive Market

On Wednesday, 21 June 2017, BioProcess International presented a panel discussion from 1:20 to 2:30 pm as part of the “Emerging Techniques and Technologies” session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Joshua Speidel (managing director of the commercial practice team at Latham Biopharm Group), this panel comprised Diane Retallack (senior director of upstream processing and intellectual property at Pfenex), Rachel Felberbaum (senior director of business development at Protein Sciences Corporation), and William Taylor…

Current Thinking in Viral Safety: Risk Management Protects Patients

BPI’s editor in chief S. Anne Montgomery recently caught up with long-time editorial advisor Hazel Aranha (purification technologies technology expert for Sartorius Stedim Biotech, North America). They discussed a number of topics related to viral safety. Montgomery: What is the current thinking regarding virus-safety assurance in biopharmaceutical manufacturing? How is the industry preventing viral contamination? Aranha: The “holy grail” of viral safety — absolute freedom from extraneous agents or residual pathogenicity — is a myth. That said, biopharmaceutical products have…

Going After a Moving Target: New Production Methods Aid in the Flu Fight

The traditional method of manufacturing vaccines for influenza involves infecting hens’ eggs with the virus, then harvesting and purifying the large amounts of virus that they produce as a result. It’s time-consuming and expensive, requiring large specialized facilities for production. With the advent of genetic engineering and decades of improvement in protein production through cell-line engineering and industrial culture, it was only a matter of time before the vaccine industry saw the real value in modern biomanufacturing instead (1, 2).…

Rapid Development of High-Quality, Robust Mammalian Cell Culture Manufacturing Processes

With increasing industry emphasis on providing both rapid and robust processes, companies are reaping the benefits of new tools for risk management and process analytical controls. As a current example of these approaches, Fujifilm Diosynth scientists have accelerated the development process from gene to finish by shortening the timeline, incorporating quality by design (QbD) principles, and designing the process to be as robust as possible. When the Apollo mammalian expression cell line was introduced three years ago, the time from…

Deciding Between Single-Use and Stainless Steel Strategies

A BPI Theater Roundtable at Interphex 2016 On Tuesday, 26 April 2016, Eric S. Langer (managing partner of BioPlan Associates) chaired a morning roundtable titled “Deciding on Single-Use vs. Stainless Steel Strategy: What the CMOs Know That Biopharma Needs” as a follow-up to a similar discussion held last year. Langer brought together a panel of four contract manufacturing organization (CMO) industry experts: Daniel Vellom (senior director of global technology innovation at Sanofi Pasteur) Sue Behrens (senior director of process technology…