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A dedicated senior project team

 

Trial batches:

 

- for compatibility study

- reduced size batches

- accelerated conditions stability study (40°C, 25% RH)

 

Production transfer project :

 

- Analytical method transfer

- Sterilization cycle scale-up

- Production process transfer

- Manufacturing of exhibit batches

- Stability studies (ICH conditions for semi-permeable containers)

- Validation package

- Documentation support

 

Commercial production