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CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.
CPhI Worldwide released the second part of its 2015 annual report, “Quality, Metrics and Continuous Processing,” prior to CPhI Worldwide 2015 in Madrid (Oct. 13–15). In the report, Bikash Chatterjee, president and CSO of Pharmatech Associates; Emil Ciurczak, president at Doramaxx; and Brian Carlin, director of Open Innovation at FMC, commented on the implications of quality by design (QbD), continuous processing, excipient criticality, and process validation for the future of pharmaceutical manufacturing.
Continuous manufacturing has the potential to reduce manufacturing costs. If used only for production, implementing continuous processing could bring 25–35% savings, and “When you expand to formulation (and clinical trials) to obviate the pain of scale-up, the combined production savings and non-existent [out-of-specification] problems could easily top 50%,” suggested Ciurczak in the report. He believes that within 10 years, all global pharmaceutical manufacturing will be continuous, and he warns that those manufacturers that fail to implement change early enough might not see out the decade. The rate of adoption is now accelerating, and he predicts we will see the industry’s leaders introducing continuous processing for one or two products per year for the next several years, then submitting only new drug applications that include continuous manufacturing. After 10 years, he predicts that the largest generic-drug companies will begin using continuous processing and that the remainder of the market will quickly follow. “The idea of CM [continuous manufacturing] can be merged with 3-D printing and making variable dosage forms, so that is another plus. The ‘process signature’ of a single production stream will also help identify counterfeits and tighten the supply chain,” concluded Ciurczak.
Chatterjee outlined that the gradual integration of QbD principles is going to be transformational during the next few years, as companies strive to implement guidelines from the European Medicines Agency (EMA) and FDA. He suggested that approaches to the 2011 FDA process validation guidance and the EMA Annex 15 guidance will converge as the industry evolves its best practices. “The adoption of the Annex 15 guidance by countries subscribing to the PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme] compliance philosophy means that this new approach to process validation will become the standard for a majority of the world markets,” concluded Chatterjee in the report. In emerging markets, larger drug manufacturers will be first to move to QbD and will benefit from sales into the United States and Europe.
Excipient variability must be managed, and the increased focus on quality metrics will lead to greater scrutiny of excipients, noted Carlin in the report. “As we move toward a more metrics-driven regime perhaps some measure of the degree of user-supplier joint due-diligence should be included,” suggested Carlin in the report.
“Regulation, metrics, and quality controls across the pharma industry are evolving, and over the next few years, our experts show that we will be working towards harmonization, improved standards, and in continuous processing, some fairly revolutionary manufacturing techniques,” said Chris Kilbee, group director Pharma at CPhI, in the press release. “At CPhI Worldwide, we want to make sure we are central to the debate around how pharma is changing, and we encourage our experts to use this forum to drive the industry forward. The annual meeting is now a place to not only do business, but also debate how we can partner and improve. By implementing the recommendations from our panel, the pharma industry will advance more quickly, develop better and safer drugs and usher in a new age of lower cost and modernized manufacturing.” The full CPhI annual report (parts I–IV) will be released at CPhI Worldwide 2015 in Madrid, October 13–15.