BIO From The Editor and Guest Columns
-
Inside J&J's Many-Indication mAb
10/30/2024
Leona Ling, Ph.D.’s relationship with the investigational monoclonal antibody nipocalimab is defined by curiosity, perseverance, and commitment. She discovered the molecule while working for Momenta Pharmaceuticals, and she continues to shepherd it long after J&J's $6.5 billion bid for it in 2020.
-
How Cidara Got Its Molecule Back
10/30/2024
In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.
-
A Comprehensive Guide For Supplier Quality Agreements
10/29/2024
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
-
Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
-
Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
10/28/2024
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
-
Safety Cabinets' Essential Role In EU GMP Annex 1
10/25/2024
A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.
-
Life Sciences Cybersecurity Incident Management: The End-to-End Approach
10/24/2024
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
-
Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning
10/24/2024
BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.
-
Exploring Sanofi R&D's Batch Monitoring Initiative
10/23/2024
The project established predictability during testing and release for the production of medicine to support clinical trials.
-
What's Next After FDA's DSCSA Extension?
10/18/2024
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.