How has the COVID 19 pandemic affected the biopharmaceutical industry in respect to:
- Manufacturing capability/capacity: Since the beginning of the pandemic, vaccine developers turned to manufacturing partners to leverage additional capacity, but also in Catalent’s case, for our product development capabilities, clinical supply services, and overall expertise in the rapid scaling-up and launching of products globally. With a pressing need to quickly vaccinate the global population, the industry put significant investment into additional multi-dose vial filling capacity for the manufacture of the very large quantities of COVID-19 vaccines that were required. Greater transparency and collaboration have also sparked innovation between partners, allowing us to move much faster than previously thought possible when working together.
- Navigating the regulatory environment: The pandemic challenged the industry to find solutions quickly, however, scientific rigor and quality could never be compromised. The unique circumstances made us consider new ways of conducting normal business activities, such as how we could successfully and safely host audits at our sites during the global health crisis. Catalent was among the first manufacturing companies to host regulatory officials on site again, as well as customers being able to visit virtually, using digital solutions that we implemented across our network. Feedback from these interactions was very positive, and we have shared many of these best practices with others across the industry.
- New drug development programs: Although there was some pullback in clinical trials during the pandemic, both in general and with new product development, we have seen a significant bounce back from those early days. The pandemic also spurred innovation, and investment in novel technologies such as mRNA, which have since become synonymous with the efforts to vaccinate billions of people around the globe. The acceleration of development timelines to support the clinical testing and approval for these vaccines necessitated a complete re-thinking of the way the industry has approached drug development. As part of the process, we have learned new and better ways of working together, which I hope will continue to be incorporated from here on.
- Supply chain/cold chain weaknesses/limitations: The pandemic created numerous challenges in the supply chain for critical components, consumables, capacity, people, and more. While we have seen this improve over the last year, it continues to be a key area of focus for Catalent, as well as our suppliers and customers. As we look to the future, we are likely to see a shift from multi-dose vials to single-dose syringes and vials to improve administration and reduce waste. This shift could further stress the supply chain, and emphasizes the importance of communication between partners to forecast and plan a variety of scenarios to de-risk supply chains.
- Staffing and operations: Catalent is well equipped with the appropriate capacity and technology to support vaccine developers scaling up quickly for commercial production. But, even more importantly, we had the people and expertise required to successfully operate continuously, allowing us to manufacture the vaccines, and hundreds of other important products every single day. Over the past two years, Catalent has hired about 2,000 employees to support its biologics business alone, and the continued growth we anticipate going forward means that we will continue to hire hundreds more in the coming months, from entry-level manufacturing to senior scientists, management, regulatory professionals, and quality experts.
- Financial considerations and growth forecast: Catalent was already actively investing in additional capabilities, including fill/finish lines, before the pandemic stuck, so the company was able to put these resources to work on COVID-19 programs as well as for other important products as soon as they were qualified. With the acceleration and installation of seven new production lines during the pandemic, we were better positioned to take on the additional demand that COVID brought, and will continue to invest across our global network to meet future customer demand.
Looking forward, how will the biopharmaceutical industry take the knowledge and lessons learned during the COVID 19 pandemic and leverage this information to create a robust and nimble industry that is prepared for future pandemics?
Not only have we innovated to provide an unprecedented reduction in development and scale-up timelines for the vaccines, we have also been party to the industry’s efforts to work together in ways that had never been seen before. This new level of collaboration between multiple partners both up and down the supply chain has created more transparency and communication from all levels of each organization which, in turn, has generated faster and, sometimes, better solutions for vaccine development and manufacturing.
We look to continue working across the industry as true partners rather than just part of transactional relationships, where we can implement the best practices of transparency and collaboration in order to speed up the development of future non-COVID-19 products.
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