Industry Insights

1. Computer Systems Validation Pitfalls, Part 4: Inattention To Details 1/24/2025

   The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

2. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

   The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

3. Easing Autologous Cell Collection, Automating Manufacturing 1/22/2025

   To circumvent the challenges of leukapheresis, CellProthera developed a novel method for collecting therapeutic stem cells from whole blood. CSO Ibon Garitaonandia, Ph.D., discusses the company's mission to streamline manufacturing.

4. 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.

5. 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.

6. 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.

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. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

    The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.