CPhI Annual Expert Industry Report: Part IIB

CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, have announced the release of the remaining findings of their annual report, with contributions from expert industry panel members Prabir Basu, Independent Consultant and former Director of NIPTE, Girish Malhotra, President at EPCOT International, Emil Ciurczak, Principal at Doramaxx Consulting, and Hedley Rees, Principal at PharmaFlow.

The remaining four articles of the annual report highlight the effects that increased regulation and new practices, including QbD, are likely to have on the global marketplace, alongside continuous processing and risks in the supply chain.

Girish Malhotra’s analysis suggests that alongside these quality and process issues, pharma is likely to change its business model towards developing lower-cost drugs that have a larger customer base, with big pharma revenues increasingly coming from orphan drugs.

However, he also sees risks of an increasingly stringent regulatory environment, with drug shortages envisaged as consolidation occurs amongst weaker players in developing countries.

Prabir Basu, in contrast, sees the greatest threat to the industry coming from uninspected ingredients and argues that it is essential that cGMP be extended to excipient manufacture.

Hedley Rees echoes these thoughts and believes that the current prescriptive approach is not adequately targeting ‘mal-intent in the supply chain’.

One solution, Basu believes, to the regulatory minefield would be for the FDA to implement a ‘trust and verify’-style OHSA Voluntary Protection Program, which would provide flexibility for cGMP sites to make modifications whilst accelerating the implementation of Operational Excellence (OpEx) without fear of shutdown. The FDA should also focus its resources on regions with the greatest likelihood of failure.

“Track and trace under FDASIA will also help to drive supply chain improvements but a change in behaviour is also needed to ensure safety. Industry is far too reliant on regulation as an excuse for not taking the initiative,” Hedley Rees noted.

Another major problem, Prabir Basu identifies, is that the current regulatory environment does not incentivise achieving excellence and is rather more focused on non-compliance. Girish identified a solution to this and believes that the implementation of PAT and QbD will not only lead to higher standards but will help remove process inefficiencies and lead to global revenue savings of 20–25%.

Emil Ciurczak also sees the benefits of these new methodologies and states that in 10–15 years’ time, it will be impossible to tell if a site is generic or a branded pharmaceutical facility.

These improvements in standards will inevitably come at the cost of market consolidation, with a generics race underway, ultimately leading to a smaller number of larger generics companies. An essential element to improve standards across generics manufacturing will be the adoption of QbR and ever-closer collaboration between the FDA and EMA.

Another benefit of QbD/PAT is the ability to vary experimental conditions, which should allow development work to progress from laboratory scale to small-scale manufacturing more quickly. Hedley Rees supported this, adding that supply chain quality should be brought into the equation at the early development stage, with poorly characterised molecules becoming redundant before development work. He also suggests regulators should raise the bar for CMC filing at the IND/CTA stage to help ensure that only the promising molecules enter the clinic.

The final area highlighted by several of the panel members, including Girish Malhotra and Emil Ciurczak, is the potential for continuous processing to revolutionise manufacturing with reduced costs, increased sustainability and constantly higher product quality, with the advent of QbD and PAT producing an enabling environment so that batch processing may be a thing of the past.

Chris Kilbee, Group Director, Pharma, commented: “The remaining findings from our CPhI Pharma Evolution annual report show that over the next few years stringent regulations and practices such as QbD are prominently shaping the global marketplace. A large number of our experts emphasise QbD in playing an increasingly large role to ensure products are manufactured to consistently high standards of quality that align with all regulatory bodies. But with increased standards does come short-term risks of product shortages, however, in the longer term we can expect huge revenue savings from these techniques, and in as little as 10 years’ time standards at generics and branded sites will be indistinguishable."  

For full copies of the submission and overall reports please visit: www.cphi.com.