ARTICLES BY LOUIS

• 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.                                                     

• Lineage Cell Therapeutics Manufactures Internally – Should You?

  11/16/2023

  Is this an example of a therapy developer with “platform technology” ostensibly pursuing its own pipeline, but also offering services as a contract manufacturer? Lineage CEO Brian Culley says no. He has a different model in mind.

• Which States Are Best To Locate Your Biotech?

  11/13/2023

  How would you go about looking for a modest-sized facility in the U.S. to establish your own development and clinical-stage manufacturing platform? How might a CDMO go about it today? We started this path of inquiry in our previous editorial. Today, the actual tour. 

• Indian CDMO Brings Continuous Manufacturing To New Jersey

  11/6/2023

  An India-based CDMO sets up shop in New Jersey to establish continuous manufacturing (CM) operations to target biologics customers in the U.S.  How did this deal materialize? What's it say about our industry?  An intriguing backstory.