Subscribe to
our newsletters

Subscribe to our newsletters!

Subscribe to our newsletter and get the latest news from the Nordics straight to your inbox.

Search in Nordic Life Science Insight

-
October 29, 2019
Bioneer

Accelerating the Protein Manufacturing Process by Including a Pre-CMC Step

Peter Hartman spoke to Rapidus about investment promotion and the new joint microbiome project with Copenhagen Capacity and Invbest in Skåne.

Accelerating the Protein Manufacturing Process by Including a Pre-CMC Step

-
Bioneer
-
October 29, 2019

Accelerating the protein manufacturing process by including a pre-CMC step

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.

Last updated:
October 29, 2019

Bioneer

Bioneer A/S is an innovative research-based company providing services within biomedicine and biotechnology.

Click here to read more about us!
Get in touch with us!
Visit us

Bioneer A/S
Kogle Allé 2
DK-2970 Hørsholm
Denmark

Send us mail

Accelerating the protein manufacturing process by including a pre-CMC step

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.

Last updated:
October 29, 2019

Bioneer

Bioneer A/S is an innovative research-based company providing services within biomedicine and biotechnology.

Click here to read more about us!
Get in touch with us!
Visit us

Bioneer A/S
Kogle Allé 2
DK-2970 Hørsholm
Denmark

Send us mail