Cell & Gene Collaborative Blog

  1. A “Portrait” of Risk In Cell & Gene Manufacturing 7/21/2023

    The eventual shape of our industry became increasingly top-of-mind as I listened to the final expert panel at the PDA ATMP conference, during which several experts shared the industry challenges currently keeping them up at night. Not surprisingly, many of these experts’ concerns revealed the tenuous relationship we as an industry have with our (often vastly different) assessments of risk in the CGT manufacturing paradigm. 

  2. ARW's CGT+RNA Manufacturing Must-Reads (Sports Cliché Edition!) 7/13/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  3. From The Lion King To Cell & Gene: “The Circle of Life” For Sustainable CGT Products & Businesses 7/10/2023

    We tend to think of sustainability predominantly in terms of environmental/social initiatives. However, the 2023 AGC CDMO Summit presentations also shed light on three additional types of sustainability — and the mindsets underpinning them — that are essential for establishing an efficient business without placing our manufacturing and quality initiatives at risk.

  4. “Our CMC, Ourselves:” 3 Iterative [Self] Improvements In Cell & Gene Manufacturing 6/30/2023

    Here, I’ll outline the three areas in which I felt the discussions at the PDA ATMP conference revealed how we can better “close the gap” between where we currently are and where we know our manufacturing processes can be in the future. 

  5. ARW'S CGT + RNA Manufacturing Must-Reads (SPAM EMAIL EDITION!) 6/19/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  6. The “Corps de Manufacturing:” Defining Flexibility In Cell & Gene Therapy Tech Platforms 6/15/2023

    Though the word “flexible” will inevitably appear in any conversation about a manufacturing facility, paradigm, or platform, we rarely stop to flesh out what such flexibility can mean and/or may look like. Here, in part two of this series, Abe Maingi of Inceptor Bio and Jason C. Foster of Ori Biotech help me chisel out how they are thinking about flexibility in tech provider partnerships in the heterogenous ATMP space. 

  7. Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships 6/7/2023

    In part 1 of this two-part article, Jason C. Foster, CEO and executive director of Ori Biotech, and Abe Maingi, VP of business development and co-founder of Inceptor Bio, share their perspectives on how partnerships must evolve to mitigate the unique scientific and financial risks facing autologous cell therapies. 

  8. ARW's CGT+RNA Manufacturing Must-Reads (Oscar The Grouch Edition!) 6/1/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  9. Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity 5/22/2023

    In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.

  10. ARW's CGT+RNA Manufacturing Must-Reads (Greeting Card Edition!) 5/18/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.