Before investing in new instrumentation, be sure that you already have what you need to gain the process knowledge that PAT requires. Richard Poska, director of global pharmaceutical regulatory affairs for Abbott Labs’ CMC, GPRD Support, Small Molecules, shares his insights.
The unexamined process cannot be improved, and process capability analysis offers new insights. Quality systems specialist Scott Tarpley, a consultant with Light Pharma, outlines the steps involved and prerequisites.
GMPs and financial disclosure are two sides of the same coin, claims Mark Livingston, plaintiff in a much-publicized whistleblower lawsuit against Wyeth Pharmaceuticals, in this exclusive reprint of a recent speech.
Bayer is using simulation and a Six Sigma DMAIC approach to adapt petrochemical process optimization techniques for biopharmaceuticals. Thomas Daszkowski, Sanjay Joshi, and Peter Ryan of Bayer Technology Services discuss what they’re doing and the progress they’ve made.
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.