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This week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships.
This week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships. The event, hosted by PharmTech and CBI, addressed many common challenges facing the outsourcing sector while also offering potential solutions. Below are a few soundbites from the second day’s discussions (see here for the first day summary).
• Tech transfer timelines need to be aggressive but realistic.
• Sponsors spend most of their time mitigating deviations. The worst deviations are those affecting post commercial lots.
• Data trending is lagging across the industry. More is needed to capture and analyze needed data, flexible data, in real time.
• Equipment and facilities can cause just as many quality problems as the science itself. And Human errors top the list.
• One big pharma rejected a batch because the data outlied historical trends even though it was in spec. Was this necessary? If this happens often, how does design space and moving within the space then offer benefit?
• Big pharma is opting to invest smaller dollars in virtual R&D operations to save costs in the long run.
• The FDA process validation guidance calls for a move from an event mentality to a life-cycle mentality.
• Process capability and process stability are very different although are sometimes confused and/or mixed up. It’s important to understand each fully and how they impact your product.
• There is huge variability among CMOS in terms of understanding QbD still. Some say it will take 25 years, or about a generation, for QbD to be common among all facets of the industry.
• Is QbD a competitive advantage for CMOs? Most say yes.