Manufacturing26 Mar 2025 09:28
Just a few thoughts on this front.
HEMO now has the lab/facilities to manufacture compliant and useable CAR T (as demonstrated by it meeting all FDA protocols for use by MDA in the trial already).
This is a cornerstone of any IND submission. HEMO are the manufacturer of the drug whilst in trials as agreed by FDA. Now, the sort of income HEMO can make from continuing to provide this service were big pharma to license/buy CAR T could/will be substantial. I asked grok. The numbers are serious. I hear FDA prefer the manufacturing to continue with the CMO on INDs where there are take overs of treatments/drugs during a trial to ensure continuity so its likely we're kept on if this were to happen.
"Hemogenyx has developed its own cGMP (current Good Manufacturing Practice) compliant facilities in New York, which allows it to produce HEMO-CAR-T cells in-house for its Phase I trials. This capability reduces reliance on external contract manufacturing organizations (CMOs) and gives Hemogenyx control over the process, potentially lowering costs compared to outsourcing. The company has completed process qualification runs, indicating readiness to produce clinical-grade CAR-T cells.
In the CAR-T industry, manufacturing costs per patient can vary widely depending on scale, automation, and process efficiency. For approved therapies like Kymriah (Novartis) or Yescarta (Gilead/Kite), production costs are estimated to range between $50,000 and $150,000 per treatment, though these figures reflect commercial-scale operations rather than small-scale trial production. For a company like Hemogenyx in a trial phase, costs might be higher due to smaller batch sizes and less optimized processes—potentially in the range of $100,000 to $200,000 per treatment. However, their in-house facility could keep costs toward the lower end of this spectrum, say $100,000 to $150,000 per treatment.
If a big pharma company were to acquire HEMO-CAR-T mid-trial and contract Hemogenyx to continue manufacturing, the income per treatment would likely include a markup over production costs to account for profit, expertise, and facility use. In such partnerships, service fees often follow a cost-plus model or a fixed-rate contract. For CAR-T therapies, commercial list prices range from $373,000 (Kymriah) to $475,000 (Yescarta) per treatment, but these reflect end-to-end costs including R&D, administration, and profit at scale—not just manufacturing. During trials, the focus is narrower: Hemogenyx would be providing a service (manufacturing) rather than the full therapy package."
Furthermore, if you consider our partnership with Kure.ai and an intention to reduce production times from 10-12 days down to 24hrs... the potential income from providing such a service/operation is eye-watering.
I can copy and paste the full AI commentary on potential income from manufacturing CAR T for big pharma somewhere if anyones interested. But I think you get my drift.
You can alway