Cell & Gene Collaborative Blog

  1. Cell & Gene Therapy COGS: Words Of Wisdom To 'Keep The End In Mind' 3/7/2023

    As a delightfully diverse space, it goes without saying that understanding a product’s process and COGS drivers will be a highly individualized and complex undertaking. However, there were a few valuable points that came up in my conversation with Dark Horse Consulting's Katy Spink that were worthy of sharing as we step back and consider what "keeping the end in mind" will look like for our development paradigm and its COGS.

  2. Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability 2/28/2023

    We regularly talk about “getting to know” our products. This can mean a lot of different things depending on the functional area in which we work. But as conversations about affordability and commercial sustainability increase pressure on manufacturing teams, I wanted to get Spink’s thoughts on how we can understand our products from a COGS standpoint and how this will continue to challenge us in the years ahead.

  3. Cell & Gene Manufacturing Risk Vs. Benefit: How It's Reflected In Our FDA Interactions 2/7/2023

    Though many important topics of conversation were broached during the 2022 FDA CMC townhalls, there were two within which the industry is working to define how much is too much or not yet enough. In the following two parts of this article, I’ll briefly unpack some of the high-level best practices offered by the FDA to help you work your way towards “just right.”

  4. GMP Principles: The True Star Of Cell & Gene FDA Interactions 2/2/2023

    The questions posed to the FDA during both the cell and gene town halls indicate that we are trying to better define “phase appropriate” development and understand where our material/vendor selection and qualification need to be more diligent. Despite the murkiness of this topic in general, there were a few best practices I took away from the FDA’s recommendations.

  5. 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023 1/24/2023

    There is truly no article more difficult to write than a takeaway article from a conference. But as I recently spent the past week attending various panels and hearing different perspectives at Phacilitate’s Advanced Therapies Week, I wanted to attempt to do “the impossible” (for me): Share four of the burning manufacturing takeaways that jumped out at me most during the week.

  6. Cell & Gene Comparability: FDA's Recommendations For Coping With Change 1/5/2023

    I wouldn’t say the FDA’s recent C&G CMC town halls provided us a clearer blueprint from which we can proceed in answering our biggest comparability questions. However, we did receive some helpful high-level reminders and/or clarifications during these town halls, several of which I’ve summarized below. 

  7. Overcoming CGT Potency Assay Woes: 4 Best Practices 12/21/2022

    Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.

  8. CGT Potency Assays: When Will We Wake Up From The Nightmare? 12/12/2022

    Here, I offer my biggest takeaways from a recent ARM/ASGCT workshop on one of the most popular topics to gossip about both in and outside the analytical labs: Potency assays. In part one of this two-part article, I start by unpacking what I see as the most prominent knowledge gaps and questions underpinning the industry’s potency assay challenge.

  9. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

    To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.

  10. "Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships 11/1/2022

    While I cannot define precisely what (or which) shape(s) risk-sharing will take for the multitude of unique CGT products in the works, I’ve been privy to several conversations that go a long way toward defining the current state of these evolving ATMP outsourcing partnerships and business models.