By Lei Zheng, Biomedical Engineering, Pfizer CentreOne
A top priority for drug developers is to find outsourcing partners with experience in transferring and scaling their product formulation and processes from sending unit (SU) to commercial-scale receiving unit (RU) in compliance with regulatory agencies.
A successful manufacturing technology transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and range of regulatory filings required.
Whether you are a drug developer searching for a CDMO partner for the first time, rising to a new role, or a veteran scrambling to fill a gap in your supply chain, there are four key considerations for gauging strong technology transfer performance: geographic footprint, technology, regulatory compliance, and talent.