Replies to post #31060 on Humanigen Inc (fka HGENQ)

[Newtg]

Jay - does Chime have the same stringent “come up to speed” requirements as the US companies, or might their ramp up be quicker than domestic timelines?

[PhrmaBro]

Jay, some comments on the Lenz supply chain.

Catalent did not need nearly as much time as others for production readiness. Catalent worked with HGEN to develop the process. I'd expect much if not all of the EUA Drug Substance/Drug Product supply at launch to come from Catalent. We also know Emergent made Lenz Drug Product.

With exception of Catalent and Chime who also supply the Drug Product, you are listing only Drug Substance supply. I expect early supply of the Drug Product - Vials, are Likely coming from Catalent and Emergent.

Finally there was some question about what requires 6 months. Rule of thumb/standard tech transfer time is about 6 months, so I agree with your timelines (outside of Catalent). This timing can be accelerated a bit.
Another rule of thumb is the production process - start to finish, RMs to packaged and quality released vials takes about 6 months. Again these are timelines that can be accelerated, but it's a challenge to do the first time running commercial product.

[cowtown jay]

I was going to look at how much production capacity was reserved for us by all of our manufacturers.

But that should prove to be pointless in trying to answer the central question of how much of our drug could be available at the earliest time.

The real question in need of answer is not relative to the number of vials produced, or that have a projected completion date.

We need to know if these early manufacturers only produced enough drug substance to meet their lenz requirements, or did the company ask them to continue producing drug substance, and build an inventory well beyond their requirements with the intention of freezing the drug substance until the company needed additional finished product. We've seen absolutely no mention of us asking our CDMO's to produce specific quantities of drug substance. But that would have been the smart thing to do. And I think we have smart people running our company, people who would have figured out a way to meet the demand projected in their modeling...if they have the revenue coming in that they projected to execute their plan.