FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
|Articles|December 1, 2017
- BioPharm International-12-01-2017
- Volume 30
- Issue 12
BioPharm International, December 2017 Issue (PDF)
Click the title above to open the BioPharm International December 2017 issue in an interactive PDF format.
Advertisement
Articles in this issue
almost 9 years ago
Transformative Medicines Challenge FDA and Manufacturersalmost 9 years ago
Biopharma Outsourcing: A Year in Reviewalmost 9 years ago
What’s in Your SOP?almost 9 years ago
Survey Measures Biopharma Career Highs and Lowsalmost 9 years ago
Reducing Cross-Contamination Risks in Process Chromatographyalmost 9 years ago
Wanted: A Highly Skilled Biopharma Workforcealmost 9 years ago
Modernizing Lyophilizationalmost 9 years ago
QbD Improves Cell-Culture Process Controlalmost 9 years ago
Single-Use Bioreactors Pose E&L Challengesalmost 9 years ago
Roadmap Leads to Innovative Biomanufacturing StrategiesAdvertisement
Related to this article
Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.
FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.
Inebilizumab (Uplizna) cut MG-ADL scores by 1.9 points versus placebo, supporting its approval in Japan for myasthenia gravis.
Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.
Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.
As data volumes explode, clinical data harmonization, hybrid cloud, and AI are reshaping biopharma IT into the industry's core growth engine.
Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.
Advertisement
Advertisement