Profacgen is pleased to provide cGMP compliant protein production services for scientists worldwide to assure that protein drug products meet with the quality standards, thus accelerating preclinical drug development process.
Current Good Manufacturing Practice (cGMPs) is the main regulatory standard for ensuring human pharmaceutical quality, which is enforced by FDA. These practices provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
With expertise in cGMP compliant protein production, Profacgen is dedicated to achieving its shared objectives by engineering its validated equipment and suites of full flexibility and high quality. The services specifically include but are not limited to the following aspects:
Cell banking services from cell line production to cryogenic storage.
Fermentation batch/fed-batch and perfusion, up to 300 Liter
Downstream purification technologies including homogenization, continuous centrifugation, filtration systems and chromatography purification systems.
“Our state-of-the-art certificated facility is designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply.” Commented Crystal, the chief marketing staff in Profagen.
Connect https://www.profacgen.com/cgmp-compliant-protein-production.htm to know more detail about the cGMP Compliant Protein Production service provided by Profacgen.
Profacgen provides process development and cGMP manufacturing services for biological active ingredients. We have ready access to state-of-the-art biopharmaceutical product development and manufacturing facilities and our staff scientists have demonstrable expertise in all aspects of biopharmaceutical manufacturing, from facility design and operation to the ability to provide best advice relating to product development. We also save our clients a great deal of time with bioprocess scale-up services. Our fermentation laboratories are equipped with state-of-the-art fermentors and bioreactors that enable us to express protein in large scale. Our customers can choose to enter into the protein purification pipeline at any stage depending on their needs.
Company Name: Profacgen
Contact Person: Ellen Burns
Email: Send Email
Address:45-1 Ramsey Road
State: New York
Country: United States