RE:RE:Sesen (Vicineum) was disqualified on that I believe that we will have to apply with an NDA rather than a BLA. Much easier IMO as TLD-1433 is an Organometallic substance ( pretty much like a salt) which is dissolved in saline when ready to be administered. Already have shown 3 years of shelf life stability. BLA is for a biological substance and much harder to produce and show consistency. Manufacturing is very often an issue. Biologics are also not as stable and have a much shorter shelf life. All IMHO
DJDawg wrote:
Quick question. I know biologic agents have different production challenges and concerns with safety and contamination in the manufacturing process.
Can we confirm that TLD-1433 has a more straightforward, non BLA production process? If so that probably reduces some of the Vicineum issues above around production. I think it does but thought I would confirm. More chance to satisfy FDA requirements in the long run.