Guest Columns

1. Upgrading The Vial/Vein-To-Vein Process With Enterprise-Level Digital Infrastructure 1/21/2025

   The cell and gene therapy's value chain has come to be known as the vein-to-vein/vial-to-vein process. Enterprise-level digital infrastructure can address the sector's challenges in a variety of ways.

2. Using Simple Spreadsheet DoE To Optimize The Protein Pipeline 1/21/2025

   Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

3. mRNA Empowering Engineered In Vivo Cell Therapies 1/21/2025

   Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.

4. Suffering High Protein Sieving Losses? It Might Be The Buffer 1/17/2025

   New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

5. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

   Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

6. Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation 1/16/2025

   API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

7. Building Frameworks To Support Complex Therapy Manufacturing 1/16/2025

   To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.

8. Audit Readiness For Cell & Gene Therapy Companies 1/16/2025

   Cell & gene therapy companies are required by regulation to qualify sites performing all the steps and methods as part of their manufacturing processes. 

9. New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings 1/15/2025

   To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

10. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

    The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.