In the second part of the CPhI Worldwide Annual Report it has been revealed that the trend towards the increased use of modern manufacturing processes and quality systems is occurring very slowly and the current drugs pipeline is discouraging.
Report
This second part, which focuses on the immediate and long-term trends in pharma manufacturing and ingredients, includes the expert opinions of Emil Ciurczak, president at Doramaxx Consulting; Brian Carlin, the excipients iconoclast, and Girish Malhotra, president at EPCOT International.
Additionally, the experts have predicted that a lack of excipient innovation and multivariate analysis are a potential growing risk, with a need for collaborations to develop new excipients. However, biologics are the most likely to support the development of new excipients, given the high product value and susceptibility to excipient impact on quality.
“The current approach of developing new drugs for rare and orphan diseases, and for only the most affluent patient cohorts, is actively discouraging manufacturing innovation” warned Malhotra. “These newer drugs are produced in smaller qualities and often feature high margins and profits — meaning the incentive to improve manufacturing processes is not there.”
“Making drugs affordable is the best long-term way to improve the total sales in the developing countries. Because of the income differences between developed and developing countries, the differences in drug processes will remain for the foreseeable future. Economies of scale and better manufacturing technologies can make drugs more affordable and increase sales,” he added. “However, to achieve all of this will require a business model review and substantial change. This is not an easy task for an industry that has not aggressively embraced change and innovation. Their focus has always been on new drug development and marketing — drug affordability is an unknown area.”
Ciurczak forecasted that it may take the industry a decade to see the full impact of implementation of modern manufacturing processes and quality systems but ‘resistance is futile’ and only adopters of these technologies will survive.
“Large companies will naturally be the first movers, followed in parallel by their strategic outsourcing partners, and this will become an established practice over the next three-years,” commented Ciurczak. “For generic companies, and particularly smaller ones, there is an existential debate pending. Do they A, close; B, merge with or acquire other small companies to have the critical mass to invest; or C, as is happening now, partner with the larger Pharma companies to produce their off-patent, older (but still in-demand) brands. In ten years, the market will be made of fewer, but larger companies, and the profit generators will be the ones that understand and properly implement QbD.”
Carlin echoed these thoughts and warned that the industry needs to move to smarter control of its processes. “Investment in PAT and data mining will involve additional costs, but this must be balanced against the increasing cost of poor quality (COPQ) associated with regulatory initiatives on quality metrics and quality culture,” he added.
In his opinion, biologics may be the exception to the rule and is the area that should more than likely support the development of new excipients. Overall, Carlin stated that regulators should provide approval mechanisms for excipients to assist in innovation.
“As the industry’s annual meeting point, the discussions next week at our eponymous global event will be vital in furthering development throughout the industry. From the experts’ point of view, long-term success is dependent on companies adopting modern manufacturing processes, including QbD and PAT, to reduce inefficiencies and excipient risks,” said Orhan Caglayan, brand director Europe, UBM EMEA. “We produce this report each year to help our exhibitors and the wider industry to stay ahead of trends and prepare for change, opportunities, and threats. It also helps our attendees to be better informed during discussions with partners at CPhl Worldwide.”