282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 2
Your active ingredient is the nucleic acid. So why does a proteolipid vehicle filing include viral clearance studies, stability data and full characterisation of a membrane protein that is not the drug? Because that protein sits on the particle surface, and a component nobody has filed before is the agency's problem regardless of what you call it. Proteolipid vehicles (PLVs), the platform Jitendra Kumar works on as Lead Scientist for Chemistry and Process Development at Entos Pharmaceuticals,...
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