This podcast features: Frances DeGrazio

This podcast features: Ed Maggio

This podcast features: Raymond Colton

In an audiocast with managing editor Maribel Rios, Rick Johnston (principal at Bioproduction Group), discusses his views on some changes in the biomanufacturing industry since his January 2008 article, “Establishing a Research Agenda in Bioproduction.” In that article, Johnston reviewed some of the industry’s operational challenges, including the need for supply chain reliability, uncertainty in demand and production processes, and variability in quality assurance and quality control. In the audiocast, he talks about steps the industry has taken toward addressing…

In an audiocast with managing editor Maribel Rios, an author looks back on his report of a unique cleaning method from BPI’s first year over a decade ago. Amnon Eylath (senior director of quality assurance at Genzyme, formerly of Amgen) discusses the two-part 2003 article, “Successful Sterilization Using Chlorine Dioxide Gas.” (Read Part 1 or Part 2 ) That article described Amgen’s development of a process for disinfecting the surfaces of an isolator and process vessels using chlorine dioxide (CD)…

Miriam Monge (from Biopharm Services) revisits her March 2010 article (coauthored with Andrew Sinclair) in an audiocast with managing editor Maribel Rios. She reviewed the industry’s economic challenges at that time, which included costs associated with treatment, increasing market competition, and the rising demand for approved biosimilar products to offset healthcare costs. They wrote, “Many issues the biopharm sector faces appear to be the consequence of a maturing industry with structural impediments to its development brought about by regulation, political…

In an audiocast with managing editor Maribel Rios, Hazel Aranha (manager of viral clearance and safety at Catalent Pharma Solutions) discusses risk assessment and management strategies since her November 2005 article, “Virological Safety of Biopharmaceuticals.” Several factors have made risk an increasingly important issue, including the globalization of the industry and concerns over emerging viruses. Some strategies for addressing risk — such as the “as low as is reasonably practicable” (ALARP) approach and conducting a cost–benefit and decision analysis —…

Process understanding is the key to mitigating risks associated with technology transfer. In 2007, Justin Neway provided strategies for combining on-demand data access, trending, reporting, and analytics to achieve that understanding throughout process development (pdf). With increasing adaptation of process analytical technology (PAT) and quality-by-design (QbD), process understanding strategies have shifted.