Step-By-Step Guide To Tech Transfer Preparation And Execution

Strong collaboration is vital to the Sponsor/CDMO relationship, and it can be facilitated through a four-step tech transfer strategy. This approach comprises a pre-transfer evaluation, creating a tech transfer plan, producing engineering and development batches, and lastly, manufacturing clinical trial product and registration batches.

Additionally, the life sciences industry is bound by near-countless procedures, practices, policies, and standards. Effective CDMO partners can adhere to that regulatory rigidity without negatively impacting opportunities to collaborate, innovate, or create mutual benefit for the client and the CDMO. This holistic approach must born out of an artfully created and diligently nourished relationship with each client, based on trust as well as proven operational flexibility and agility.

JHS ensures every product meets both our and sponsor expectations through its lifecycle, leveraging internal project managers, reliability engineers, and Lean Six Sigma black belts to evaluate performance data and improve processes through their lifecycle. JHS also may aid in the production and submission of registration/submission packages for various regulatory agencies, as well as respond to time-sensitive, process-relevant queries from regulators during the approval process. On-time tech transfer itself is the bare minimum deliverable.