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 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.
Our dedicated team of specialists will be happy to discuss any of your Technology Transfer & Scale-Up needs. Contact us on +34 948 346 480 or email withinus@3pbio.com
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It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.
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It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.
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It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.
