We have what it takes to help you deliver advanced medicines. It's within us. 3P Biopharmaceuticals // Mammalian CDMO

Mammalian Technology Transfer & Scale-Up

Use 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 Mammalian Technology Transfer, scale-up and non-GMP manufacturing?

To take 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 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 3P 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.

Our dedicated team of specialists will be happy to discuss any of your Mammalian Technology Transfer & Scale-Up needs. Contact us on +34 948 346 480 or email withinus@3pbio.com

Mammalian Technology Transfer

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