At BioSpring, quality is the cornerstone of everything we do. Whether we are manufacturing nucleic acids for research and development or manufacturing and analyzing active pharmaceutical ingredients (APIs) and drug products, our clients can always expect the highest quality, regardless of the scale. We strictly adhere to current Good Manufacturing Practices (cGMP) as mandated by leading regulatory bodies, including the FDA, EMA, PMDA, and German authorities. Our dedication to quality ensures that our clients receive the excellence they require at every stage of the drug development process.
Quality Systems for Nucleic Acids
Commercial & Clinical Therapeutic Nucleic Acids
Since 2007, BioSpring's manufacturing facilities and analytical laboratories have been current Good Manufacturing Practices (cGMP) certified by the German authorities. Our comprehensive cGMP quality system complies with the standards set by the FDA, EMA, and PMDA. We underwent our first FDA pre-approval inspection (PAI) for an analytical oligonucleotide program in 2016 and have been a commercial, FDA-inspected manufacturer of oligonucleotide APIs since 2020. In November 2024, BioSpring has been granted manufacturing authorization (ICH Q7) for cGMP-grade mRNA production from the German authorities.
As a registered API manufacturer with both the FDA and PMDA, we are committed to adhering to ICH Q7 guidelines, ensuring consistent quality in API production. We are frequently and successfully audited by leading pharmaceutical and biotech companies worldwide.
BioSpring is ISO13485- and ISO9001-certified, and FDA 21 CFR 820-compliant, underscoring our commitment to maintaining the rigorous quality controls necessary for the manufacture of commercial diagnostic oligonucleotides. Our robust quality system ensures consistent, high-quality production, aligned with international regulatory standards, to support our clients' diagnostic needs.
By partnering with BioSpring, you can be confident in our ability to deliver quality and precision, supporting the success of you diagnostic programs.
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