Despite the buzz about "process understanding" and PAT, vaccine manufacturing remains defiantly un-PAT-able and an extremely risky business. Chiron's recent Fluvirin case offers important lessons in due diligence, quality management, and GMPs. However, it also points out an urgent need for incentives and regulatory flexibility.
A Pfizer public education campaign and its cute mascot are praiseworthy, but neglect to mention the key stage in a drug's life. What will it take to make manufacturing a hot button issue and to better educate the public?
PAT demands cultural change, not only within pharmaceutical manufacturing companies but also within FDA. Currently, the skills, training and background of FDA inspectors vary widely. Can they make the leap from the traditional chemistry-based quality approach to a future grounded in analytics and instrumentation?
At a recent Pharmaceutical Process Analytics Roundtable meeting, the latest results of a PAT survey of pharma and biopharma companies were released. In this exclusive article, PAT Insider examines findings and their implications for the future.
Although PAT is certain to change pharmaceutical manufacturing, it is difficult to tell how PAT will influence excipient manufacturing. Brian Carlin and Christophe Massip of FMC Corp. discuss how the company is using PAT to make its Avicel product, within the broader context of PAT in the pharmaceutical industry.
For December 2004's PAT Insider, we posed the following question: Is biotech ahead of, or behind, the curve where PAT implementation is concerned? What are the biggest challenges that bioprocessing operations pose, and how can some of them be addressed? The response, from Ian Clegg and David Hughes of the ABB Centre of Excellence for PAT, follows.
As Albert Einstein once said, “If you are out to describe the truth, leave elegance to the tailor.” A PAT dossier, describing your process from a scientific and technological standpoint, will be the log for your technical journey. This article summarizes what should go into this important record.
This article by Tina Larson and Dr. Harry Lam of Genentech examines the applicability of process analytical technology (PAT) to biopharmaceutical manufacturing and discusses the benefits and challenges involved.