Tech Transfer & Scale-up

Select our Tech transfer/ Scale-up and non-GMP manufacturing services to deliver transfer and scale-up reports, master batch records and sampling plans.

Our unparalleled transfer services ensure a comprehensive transfer of knowledge, product, and process-related information from our development team to the GMP manufacturing group. This transfer is crucial to the project’s success as it forms the baseline for all further process scale-up and non-GMP batch activities.

To take a promising drug candidate from the early stages of clinical manufacturing through to commercial manufacture requires a reliable and scalable process, and we excel at transferring processes from clients and other CDMOs to our facilities..

We prepare documentation to establish upstream and downstream unit operations during the project’s development stage, which is refined further during the scale-up activities and non-GMP batches. We perform engineering runs to evaluate and confirm that the process is robust and under control. Material generated during the engineering batch can be used as a reference standard and/or for stability studies.

We recommend that the product obtained is used for formulation screening and placed on stability testing to understand the product’s shelf-life and its behaviour under different storage conditions (accelerated and stress conditions).

Rely on us to develop a reliable process to carry your drug from the early stages of clinical manufacturing through to commercial manufacture with success.