Realising the Practical Advantages of PAT and QbD: from R&D to Manufacturing

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Pharma IQ
11/04/2011

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The principles of quality and efficiency in pharmaceutical manufacturing have arguably never been more important. For companies facing increasing competition from generics, everyday counts when it comes to getting a new drug to market, as does maintaining high standards and compliance.

With this in mind, more companies are searching for ways to optimise their pipeline, from research and development to manufacturing.

Janet Woodcock, director of the Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA), speaking at a recent summit of the American Association of Pharmaceutical Sciences (AAPS), predicted one of the trends which will be seen in a shift away from batch manufacturing to continuous manufacturing.

"Right now, manufacturing experts from the 1950s would easily recognise processes today. In 25 these same processes will be obsolete," she said.

Compliance officer Francis Godwin also extolled the benefits of continuous manufacturing at another recent conference, highlighting that advantages include less materials being needed for experimental runs, reducing the amount of time products are left on the floor and subsequently cutting costs, in-Pharmatechnologist.com reported.

The FDA has also been exploring the virtues of Quality by Designer (QbD) of late, both in its own operations and for pharmaceutical companies.

Woodcook told the AAPS audience that within the next 25 years she can see QbD being used in clinical trials to boost efficiency and maintain the highest levels of quality with less intrusive oversight.

Stephen Byrn,head of the Department of Industrial and Physical Pharmacyat Purdue University, who has been working with the FDA on the benefit of QbD, previously suggested the principle could double the number of clinical trials taking place.

"The number of drugs reaching the market has dropped from about 50 to about 15 per year," he told Pharma QbD. "We're putting out about a third of the drugs we should be, based on our earlier performance. At the same time, the cost is rising about as fast as the number of drugs on the market has dropped."
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His suggestion for solving the issue was putting more drugs into human clinical trials, then reduce the length of time it takes for Investigational New Drug Application filings.

The FDA and the European Medicine's Agency (EMA) joined together for a new pilot scheme launched earlier this year based on the QbD principle, which will ultimately "increase information sharing and reduce redundancy," Woodcock said when the programme was announced in March.

Under the programme, both the FDA and the EMA will assess the evaluation of relevant development and manufacturing data components of applications submitted to both agencies in parallel.

The programme was launched out of the fact that agencies were becoming concerned that the International Conference on Harmonisation (ICH) guidelines were being interpreted differently on opposite sides of the Atlantic, and will involve regular consultation between agents in the FDA and EMA.

Goals of the programmes, which accepted its first application from Pfizer, are to ensure constant implementation of ICH guidance, increase awareness of regulatory concepts among staff, define the reviewer and inspector interaction for QbD applications and create new opportunities for knowledge sharing

Pfizer has also seen benefits from the implementation of process analytical technology (PAT), described by Consultant Dennis Brandl as "using the knowledge of the process itself to control the quality of the process".

He told Automation World: "[It] cut Pfizer's time to integrate devices by a significant chunk. Instead of integration being ten times the cost of the devices, it night only be one or two times the cost."

For their benefits, the pharmaceutical industry does still have challenges in implementing QbD and PAT. A survey from Pharma IQ found 65.2 percent of professionals think further guidelines are needed around submissions, with just over 13 percent of those polled having successfully made a submission.

With almost 70 percent of respondents also saying their company had a specific strategy in place for better QbD adoption, those which don't are likely to find themselves left behind.