Analytical method development
and process controls
Analytical methods design and analytical controls are critical aspects of biopharmaceuticals development, GMP manufacturing and product release.
We offer full method transfer, development, qualification and validation of biochemical and microbiological quality controls of process intermediates, bulk API, drug substance as well as Master and Working Cell Banks.
The QC department is also responsible for testing and monitoring of the environment of the production suites, incoming raw materials and performing ICH based stability studies.
All QC testing is performed 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.