RE:RE:ONCY Corporate Investor PresentationIn 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, which is straightforward to prepare for patient infusion and easy to ship and store over the long-term. Once in the doctors clinic the product can be stored in a normal in-clinic freezer for short-term storage, which is usually a few days until the product is administered to the patient, thus preparing the product for the current and future clinical trials, and for a Big Pharma hand-off.