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.
Normally, cGMP manufacturing follows after process development procedure. Scientific staffs will transmit the process that is validated from the first Feasibility Study step to cGMP manufacturing staff and QC in a collaborative manner. The manufacturing process will not be changed when clinical trials initiate.
Profacgen is capable of providing cGMP compliant Protein Production service for our customers, which assures that protein drug products meet with the quality standards, and thus accelerate preclinical drug development process.
Our team has been dedicating to achieve our shared objectives by engineering our validated equipment and suites of full flexibility and high quality, and that ensures us a consistent and in-controlled operation.
Specifically, our cGMP compliant Protein Production service including - but 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.|
Qualified class 10,000 and 100,000 cleanrooms with class 100 biohoods.
Production and purification of proteins expressed in mammalian and microbial systems.
Dedicated upstream and downstream cleanroom suites.
Independent QC and analytical testing laboratories.
Reliable cell banking services.
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. From the very beginning to our shared target, you can always trust us on our first-class facility and professional manufacturing capacity.
Please contact us for more details of our preclinical cGMP compliant protein production. Our experts will provide and help design an optimal solution for your project and trouble-shoot for you throughout the whole process.