By Lei Zheng, Global Technology & Engineering, Pfizer CentreOne
Pharmaceutical developers are increasingly relying on external manufacturing partners for expertise to develop and commercialize their products. In fact, contract development and manufacturing organizations (CDMOs) now process and manufacture approximately 28 percent of the world’s prescription and non-prescription drugs.
Innovation is coming from all corners of pharma including independent labs, scientific consortia, academia and government programs. These emerging sources of drug innovation often have excellent science but few resources and a lack of experience in commercializing formulations and drug product concepts.
A priority for many sponsors, therefore, is finding partners with the specific scientific and technical capabilities to transfer their formulation chemistries from a source unit (SU) to the commercial-scale receiving unit (RU) in compliance with regulatory guidance.
At the beginning of any commercial relationship with a CDMO, there is a technology transfer. Over the product lifecycle this may occur with other external partners and a product’s continued success can depend upon it. Whether you are a drug developer recruiting a CDMO for the first time, or in a new role, you may have questions or knowledge gaps on technology transfers. To help your understanding we’ve compiled a beginner’s guide to technology transfer fundamentals.