ARTICLES BY LOUIS

• Technical Talent Tailing Off At CDMOs?

  1/11/2024

  “Having been outsourcing to CDMOs for 20 years in the small-molecule space, I see a distinct difference in technical performance compared to my mid-2000s CDMOs," says an executive. What's going on here?

• Development And Commercial: 2 Supply Chains For An Ideal Future

  1/5/2024

  How do you transition a supply chain utilized for your development stages to a robust commercial supply chain? Thierry Bilbault knows how. He does done it before, and is at it again. He shares his strategies and secrets.

• 2024: An Outsourcing Future of Information Sharing

  1/3/2024

  I'm a big believer in open-source information as much as possible,” says Nana Collett. “Companies need proprietary information, but I'm a bit radical this way. I believe that as an ecosystem, we're going to get stronger if we can find our way to more data-sharing.” 

• Oligonucleotides Outsourcing In 2024

  12/26/2023

  2023, among other potential designations, was the year of oligonucleotides. Accordingly, here’s a question I raised with professionals throughout the year: How do you successfully outsource development and manufacture of an oligo program?

• Will 2024 Unlock Options Enabling Our Technologies

  12/20/2023

  Our Advisory Board members describe their outsourcing experiences during 2023, and offer us ideas and questions on how to make 2004 a better environment, specifically for all our advancing platforms.

• How To ID The Best CDMOs

  12/13/2023

  It takes a certain, trained perspicuity to identify the CDMO right for you. If you are a small biotech, says CEO Matthias Schroff, you most likely will not have the weight to ensure an external partner’s “real focus on producing for you.” Here's what he recommends.

• Switching From Car T To Car M Changed An Outsourcing Strategy

  12/7/2023

  A strategic switch in focus from a CAR T program closing in on the clinic, to a CAR M program further back in development but generating more excitement, drove the divesting of a manufacturing facility, and a whole lot of change. Part 2 of an investigative series.

• Stealth CDMO Reveals Secrets Of The Cell-Therapy Industry

  12/4/2023

  For months, kept under stealth mode was an emerging cell-therapy company’s plans to spin out its development and manufacturing facility as a CDMO. No, not a stealth biotech. A stealth CDMO. Part 1 of an intriguing investigation.

• Quality And Regulatory Professionals Joined At The Hip

  11/27/2023

  The context and scope of what quality, regulatory, and technical teams – CMC development professionals – need to accomplish has changed dramatically.  It’s a different paradigm, and when you add a CDMO to the mix, it's a very interesting conversation. 

• A Cell Therapy Company's “Unpopular” Internal Manufacturing

  11/20/2023

  “As unpopular as this may be with your readership ... I think it's important to own, control, have complete oversight and a seamless process at an internal manufacturing facility with your own team.” No worries about being controversial, CEO Brian Culley. Please go on.