Quality Systems for Oligonucleotides
Commercial & Clinical Therapeutic Oligonucleotides
Since 2007, our manufacturing facilities and analytical laboratories have been Good Manufacturing Practices (GMP) certified by German authorities. Our commercial GMP quality system strictly adheres to the GMP standards of regulatory agencies, including the FDA, EMA, and the PMDA.
GMP Certificate
In 2016, we successfully completed our first FDA pre-approval inspection (PAI) for an analytical oligonucleotide program. As of 2020, BioSpring is a commercial, FDA-inspected manufacturer for oligonucleotide APIs. In addition, we are a registered API manufacturer with the FDA and PMDA.
FDA Certificate of Registration
PMDA Certificate of Registration
Ensuring our clients receive the highest quality is our primary initiative. We strictly adhere to ICH Q7 guidelines to ensure consistent quality and production of APIs and undergo more than 20 successful client audits each year.
Commercial Diagnostic Oligonucleotides
We are ISO13485- and 9001-certified, and FDA 21 CFR 820-compliant. Our quality system ensures the consistent quality that is necessary for the manufacture of commercial diagnostic oligonucleotides.