RE:RE:RE:RE:Sesen (Vicineum) was disqualified on that After reading this over again, we have one major heck of an advantage when it will come to file for FDA approval. TLD-1433 being a small molecule drug will go through the NDA pathway, vs BLA. This says it all.
Manufacturing of Biological Products is Inherently Riskier than Production of Drugs.
The manufacturing processes for biological products are different than processes for pharmaceuticals. Traditional drug products are typically manufactured using pure chemical substances that are sterile, and the end products can be relatively easily analyzed. On the other hand, biological products are made from living organisms and are much more complex in nature — making product analysis very difficult. Indeed, most biological products are defined by the manufacturing processes used for production. The manufacturing process and manufacturing facilities are so crucial to biologics that “purity” is part of the agency’s requirements for licensing.
The FDA strictly controls changes to the manufacturing processes that evolve during the development of the biologic, as well as after licensing. Biologics are much more sensitive to process changes than are drugs – even a small change in the manufacturing process can result in an adverse change in the biological product. This is why biological products are regulated under the PHS Act. Initial manufacturing procedures are detailed in the IND application and then modified as needed throughout the IND phase of clinical evaluation and through the final BLA submission.
enriquesuave wrote:
All of the competition that TLD-1433 faces are Biological drugs, hence much harder to get approval and riskier. IMO N-803, Vicinium, CG0070, Keytruda etc.
That is one heck of a key advantage. They already proved safety, efficacy is in the process and Manufacturing is a joke vs the competition. IMHO
"While, biologics and drugs are both used for the same purposes — to treat, prevent, and cure diseases — biological products are much more complex in nature. By comparison, common drug compounds are relatively simple."
"A key consideration is that an NDA needs to show that the drug is “safe and effective,” while the BLA is required to ensure the licensed biological product’s “safety, purity, and potency.”
https://criterionedge.com/what-are-the-major-regulatory-differences-for-getting-a-biologic-product-versus-a-drug-compound-into-the-marketplace-bla-vs-nda/
"Manufacturing of Biological Products is Inherently Riskier than Production of Drugs.
The manufacturing processes for biological products are different than processes for pharmaceuticals. Traditional drug products are typically manufactured using pure chemical substances that are sterile, and the end products can be relatively easily analyzed. On the other hand, biological products are made from living organisms and are much more complex in nature — making product analysis very difficult. Indeed, most biological products are defined by the manufacturing processes used for production. The manufacturing process and manufacturing facilities are so crucial to biologics that “purity” is part of the agency’s"
https://criterionedge.com/manufacturing-and-immunogenicity-are-key-considerations-for-approval-of-biological-products-bla-vs-nda/
enriquesuave wrote:
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.