By Anna Rose Welch, Director, Cell & Gene Collaborative
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As I began plotting this article series following my conversation with Katy Spink, COO and managing partner of Dark Horse Consulting, I couldn’t help but think of lyrics from the Broadway hit song, “Seasons of Love” [Rent]: “525,600 minutes; How do you measure a year? In daylight, in sunsets, in midnights, in cups of coffee?”
I daresay many of you will agree that coffee consumption is an apt metric for measuring the passage of time. But a vastly different set of “metrics” appears if we take the song’s original question — how do we measure a year? — and apply it to the world of CGT manufacturing. Not surprisingly, the answers are infinitely more difficult to put to music.
The defining characteristics of the past year in the CGT manufacturing space can be broken down into the following broad categories:
- Supply chain and capacity challenges;
- Analytical and clinical disappointments;
- Clarifying quality control and compliance expectations;
- Hefty investments, licensing agreements, acquisitions, and mergers; and,
- Internal process development and documentation growing pains.
These are the areas into which Spink and I ventured freely during a small Cell & Gene Collaborative forum prior to the end of 2021. What ultimately emerged from our conversation about these year-defining trends and 2022 predictions was a list of “New Year’s Resolutions” for CGT companies striving to meaningfully progress their manufacturing programs over the next year. Of course, “meaningful progression” will mean something different to every company and manufacturing team. But, broadly speaking, to achieve the mature CGT manufacturing future patients need and deserve, each and every aforementioned bullet point will need to advance, both individually and collectively.
Spink was clear that manufacturing maturity in the CGT space is still far from being realized in any corner of the CGT manufacturing landscape. However, the resolutions linked below (in no particular order) provide some best practices we can implement and/or knowledge with which we can equip ourselves in the upcoming year. This way, in a year’s time when we look back on 2022, we will have a firm baseline from which we can measure just how much more sophisticated the CGT manufacturing sector has become.
2022 CGT Manufacturing New Year’s Resolutions
- Brace For Continued — But Nuanced — Investments In Manufacturing & Infrastructure
- Explore Novel Partnership & Outsourcing Structures
- Embrace — Don’t Fear— Deep Characterization Of Your Products
- “Work Backwards” When Capacity & Supply Chain Planning
- Find Balance Between “The sky is falling!” & “Surprise!” In Communicating Risks