RE:RE:RE:RE:RE:ONCY Corporate Investor PresentationThe FDA is involved and notified whenever major changes have been implemented including the manufacturing changes outlined in my previous post and that have been highlighted in bold font.
In ONCY's Q4 2023 Earnings Conference call Allison Hagerman outlined that: In the fourth quarter of 2023, ONCY initiated a new GMP production campaign with the drug substance process transitioned to single use equipment and scaled up to a 200 liter bioreactor. Now larger bioreactors can be employed when FDA approval is granted.
The first GMP batch was completed this last quarter and routine manufacture was being established, followed by the validation batches. These are the steps necessary to show the FDA that the manufacturing process is scaleable for product approvability and can be delivered to the clinic in sufficient quantities that satisfies a security of supply of product to the FDA that is a requirement for the granting of a FDA approvalble letter.
In conjunction with the scale up, ONCY also optimized some upstream elements of the process, including a change in detergent to align with European long-term guidelines. This expands on pelareorep's global commercialization.
In addition ONCY also completed a second automated drug product fill in a full isolator system, which allows for larger quantities per lot and reducing the cost of goods. Pelareorep is now produced in single dose vials,