Consultants at Xyzagen were involved in supporting the biopharmaceutics component of an extended release formulation technology transfer for a client who owned the NDA for the reference listed product. This was no ordinary technology transfer from one manufacturing site to another. It involved a site change, formulation change and API supplier change.
This client wanted to transfer an older extended release product as the RLD from their third party supplier to a company owned manufacturing facility. The old extended release product was a dual beadlet biphasic release product that utilized a pan coating technique, whereas the new product was a single beadlet product produced in a fluid bed.
Xyzagen’s consultants were responsible for the clinical strategy and operations of this program and the clinical lead during FDA interactions. In collaboration with the client’s pharmaceutics and manufacturing group, Xyzagen helped evaluate the in vitro comparative dissolution release profiles of the different formulations compared to the RLD release profile to identify which potential formulations may be advanced into a clinical bioequivalence study.
The team submitted a meeting request to the FDA in order to discuss the technology transfer strategy. After the interaction with the agency were completed, the plan was placed in motion. Xyzagen’s consultants designed the trials, determined power and sample size and oversaw the clinical conduct and bioanalytical analysis at the vendors.
Intrasubject variability was assessed in one trial, bioequivalence was established in a second trial and the food effect was evaluated in a third trial. Xyzagen’s consultants provided the technical writing for the clinical portion of the Prior Approval Supplement (PAS) and the product transfer was approved.
Learn more how Xyzagen’s consultants can support your Phase 1 healthy volunteer bioequivalence and technology transfer programs. Whether it is a simple transfer of the manufacturing process or a complete change in formulation for the Reference Listed Product.