CAR-T Manufacturing: Guidance Anticipates Platform Challenges And Opportunities
Draft from US FDA advises sponsors on how to draw from platform knowledge, while anticipating issues associated with emerging centralized and distributed manufacturing approaches for autologous and allogeneic products and their viral vectors.
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US FDA Expects Updates On Investigational Gene Therapy CMC Improvements
Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.