CMC – Gene Therapy’s “Achilles Heel”
Patient access to novel gene therapies is often obstructed by manufacturing challenges, in particular, issues with Chemical, Manufacturing and Controls [...]
On-Demand Webinar: Navigating the Path to the Clinic And Beyond For Gene Therapies
Bringing novel gene therapies from the drawing board to patients requires careful consideration of each step of the pipeline. A [...]
New FDA CMC Draft Guidance Released for Personalized Antisense Oligonucleotide Products
Many patients rely on personalized medicine like antisense oligonucleotide (ASO) products for complex or treatment-resistant conditions. Meeting the needs of [...]
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