The rationale behind such early pre-CMC development is that biologics manufacturing process development including final formulation usually takes a long time not at least at CMO’s which are bound by strict procedures to secure sound and safe manufacturing processes.
However, Bioneer and the aforementioned partners has experienced that if an open pre-CMC process is initiated early alongside with contract negotiations a number protein formulation and stability experiments can point to the final recipes or at least narrow down the final formulations to be implemented at the CMO. In the last 3 years Bioneer has renewed and expanded its downstream process infrastructure and has also invested in equipment which enable accelerated stress testing.
Feel free to contact Head of Department Søren Madsen via mail or telephone +45 45 160 444, if you have any CMC related questions.
Read more in the paper published in the DANSK BIOTEK magazine No.3 2018 here. You will find the whole story on pages 8-11.