iSpeak Blog

Future of Continuous Manufacturing: Large and Small Molecule

Kelvin H. Lee, PhD

When we first launched the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017, we benefited from an incredible enthusiasm and engagement from across the ecosystem. At the time, academic institutions were working to establish proof of concept for new technologies and assays for biopharmaceutical manufacturing, and they were also developing and enhancing training of the next generation process development scientist. Major companies were working aggressively to develop and bring to market an ever-expanding set of candidates, and of modalities, to the benefit of patients. Large suppliers innovating manufacturing technologies and analytical approaches needed to help accelerate development timelines and allow for increased flexibility in manufacturing paradigms. Small companies were bringing innovative manufacturing technologies, and products, to market. And government scientists, from a wide range of agencies, engaged with biopharmaceutical manufacturing technologies were focused on ensuring our society has access to a safe, reliable, and efficacious supply of medicines based on the best available science and measurement technologies.

One of the key visions for each of these parts of the ecosystem independently, and working together, has been to move the community towards a future of continuous manufacturing for large molecule products. On the one hand, the technologies are largely available for key aspects of drug substance manufacturing and movement in this direction is arguably a question of reducing business risk enough for companies to move forward on this front. On the other hand, I would argue that there are many technologies, control strategies, and cultural shifts needed before the industry is ready to adopt a fully continuous, end-to-end, vial-to-vial manufacturing process for proteins and antibodies that includes drug substance and drug product manufacturing. I'm incredibly excited that the community is driving in the direction of continuous manufacturing.

2020 ISPE Continuous Manufacturing Virtual Workshop

For our community to realize the continuous manufacturing vision for drug substance and drug product, we need to share when it is appropriate to share and to collaborate when it makes sense to collaborate. Given the constraints placed on travel and face-to-face meetings caused by COVID-19, the crucial and necessary exchange of perspectives and ideas across organizations that so often occur for us over breakfast, at a poster session, or lingering after a meeting, has not been possible in the same way. That said, while we wait for a vaccine that will help get all of us back closer to our original professional lives, let’s take advantage of this well-designed and potentially impactful opportunity to share and engage through the upcoming 2020 ISPE Continuous Manufacturing Virtual Workshop on 3 – 4 June.

In addition to a number of plenary and parallel sessions focused on continuous manufacturing, individuals from the FDA, industry companies, and academia will be presenting about state-of-the-art ways to accelerate adoption of continuous manufacturing approaches. The plenary sessions will cover topics applicable to both small molecules and large molecules followed by parallel workshop sessions focused separately on small molecules and large molecules. Each of these breakout sessions will address specific technologies, case studies, or highlight current thinking.

Personally, I'm looking forward to some of the large molecule presentations both on how specific companies and academic efforts are being deployed to help us achieve our continuous manufacturing future. But, I'm also excited to hear some of the perspectives from industry leaders in this space. In a session I am helping lead, talks from GSK, Janssen, and Sanofi - the industry leaders in this space - will give us their perspectives on upstream, downstream, and facility-wide experiences related to continuous manufacturing.

ISPE designed sessions to provide ample opportunity for question and answer between audience members and speakers as well as providing an opportunity to hear from the FDA and USP in the closing plenary session. And, while we all long for and wish this could be face-to-face, the virtual format will allow this vital exchange of experience and knowledge we seek to take back and help our own organization’s capabilities and knowledge. I encourage you to take advantage of this virtual workshop, which is a chance to share and to learn about how our ecosystem is moving towards continuous manufacturing. While I won’t be able to stand next to you at a poster or share a beer, I hope you will join me online.

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