RE: Tech transfer8 Sep 2020 20:03
I’d say there are five essential factors for efficient tech transfer:-
A comprehensive tech transfer document:
Reflecting deep product understanding and includes all the important parameters of your bioprocess, analytical procedures and critical quality attributes (MoA, CQAs etc.)
CMO capabilities aligned with your requirements and goals:
Clear goals setting up front
Timelines, costs and deliverables meet your needs
Expertise and quality oversight in the specific applications required
Capacity
Communication – open and often
Transparency
Contract SOP embodying a robust plan:
Clearly defined roles and responsibilities
Process and facility map
Analytics transfer
Process development as necessary
Demonstrated equivalence at the starting scale/process:
Proof of concept engineering runs at scale prior to GMP
Clear, frequent and transparent communication:
CMO transparency—being able to go into the plant to see how the process is run, and being able to bring the process back in-house, i.e. (including reverse knowledge transfer).