The production of GMP products are manufactured under a comprehensive quality system designed, implemented, controlled, and documented to ensure the quality of the product is as required in a risk assessed manner.
All quality systems are in compliance with relevant pharmacopoeia, FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.
We produce parenteral biologics
Highly scalable manufacturing from gram to kg quantities of plasmid for use as DNA vaccines, non-viral gene therapy or starting material for viral vector production.
More than 30 years of experience in the production and purification of recombinant proteins for human use, we are ready for your project goals.
Experience coupling peptides, proteins, polysaccharides and PEG to proteins for use human use with numerous coupling strategies.