Can continuous manufacturing fix pharma's shortfalls?
24 July 2020
COVID-19 has pushed the pharmaceutical sector to the forefront of public consciousness. With the high financial and time burden of developing medicinal products on show and disruptions threatening supply, the case for continuous manufacturing is stronger than ever.
Paying the price for ‘staying safe’
The pandemic has underlined fundamental flaws in the legacy batch manufacturing technology - currently the mainstay of the industry - with companies struggling to meet fluctuating demand. They are also coping with significant international disruption as the geographic concentration of manufacturing, from India as the world’s biggest exporter of generic drugs to China as a producer of pharmaceutical materials, has been revealed as a vulnerability. While attention has been pulled towards the development of a vaccine, other more traditional medicines, such as hydroxychloroquine, have also had a significant part to play in the global battle against COVID-19. The supply of these medicines has already seen challenges, and for products with lead times over 12 months it has highlighted an immediate and dangerous shortfall in the capability of manufacturing processes to meet the market demand.
A new light on the value of flexibility and adaptability
Continuous manufacturing has long been a niche manufacturing technology, used sparingly and blighted by the lack of regulatory clarity involved during the development of the process. However, the potential benefits are now gaining traction, as the traditional batch methods of the past 30 years are suddenly being questioned. COVID-19 has significantly increased the perceived value that some of these benefits bring to drug production, such as:
- process adaptability during product development;
- supply chain resilience to demand fluctuation; and
- supply chain flexibility via small scale portable production facilities.
The combination of these, as well as others, would no doubt have better prepared the industry for the challenges that the global pandemic has presented over the past 8 months.
Public sentiment around pharma has been mixed in the past but our research found almost four in five of us (78%) believe pharma companies are working hard to develop vaccines and solutions, while three quarters (74%) believe they’re working hard to ensure patients get access to required medicines (PwC Research Quantibus, April 2020). Redressing manufacturing processes is one of the ways pharma can secure supply to meet these high public expectations and earn trust.
Understanding the barriers to changing for the better
The switch from a batch process to continuous involves both financial investment and regulatory collaboration, for which there is now a clear case. A new joint paper from CMAC and PwC, highlights nine critical considerations for developing the business case for continuous manufacturing. Through these lenses, a holistic case for continuous manufacturing can be made to drive the uptake of this currently novel technology.
The report dives into the different factors you need to consider, connecting the dots to bring together the broad impact of a shift in manufacturing technology. These insights will explore the commercial potential of continuous manufacturing and evolving questions about how the industry currently operates.