Microbial GMP Manufacturing
Be assured that products intended for human or animal use are manufactured consistently, in a controlled manner, and are replicable, ensuring the products' efficacy, safety, and quality.
With you on your biologics journey...
Why microbial GMP manufacturing?
Good Manufacturing Practice (GMP) methods assure that products intended for human or animal use are manufactured consistently, in a controlled manner, and are replicable, ensuring the products’ efficacy, safety, and quality.
3P´s GMP manufacturing service
All cGMP material produced by 3P is manufactured according to applicable EMA, ICH or FDA cGMP guidelines.
Our Quality Control department tests all Drug Substance using the analytical methods jointly defined with you in earlier stages. It is then released according to the product specification by our Quality Assurance team. Each batch is accompanied by a Certificate of Analysis (CoA) and a Certificate of GMP compliance.
What we will deliver
We deliver efficient and reliable cGMP batch manufacturing, including all relevant documentation supporting clinical studies or commercial product supply.
Our dedicated team of specialists will be happy to discuss any of your GMP Manufacturing 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.
