Microbial Technology Transfer & Scale-Up
Benefit from our capabilities to produce transfer and scale-up reports, master batch records and sampling plans, as well as non-GMP material for use in other research studies.
With you on your biologics journey...
Why do microbial technology transfer, Scale-up and non-GMP-manufacturing?
Taking a promising drug candidate from the early stages of clinical manufacturing through to commercial manufacture requires a reliable and scalable process.
A thorough transfer of knowledge, product, and process-related information from our development team to the GMP manufacturing group is crucial to the project’s success in forming the baseline for all further process scale-up and non-GMP batch activities.
3P´s Tech transfer/ Scale-up and non-GMP manufacturing services
We prepare draft 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. Typically, we perform one engineering run 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).
What we will deliver
We will produce transfer and scale-up reports, master batch records and sampling plans. In addition, we provide non-GMP material if available, for use in other research studies.