BioSpring is a well-established oligonucleotide manufacturer for commercial diagnostic applications such as forensics, HLA-typing, microbial & viral testing and early-stage research & development projects in the field of diagnostics. BioSpring offers manufacturing compliant with ISO 13485 and FDA 21 CFR part 820.
Our scope of services includes:
- ISO13485 certified Quality System (QS) regulation
- FDA compliant manufacturing (cGMP diagnostics)
- High and consistent quality
- Full traceability of raw materials and process steps
- Qualified supply chain
- Broad range of analytical methods
- Broad spectrum of oligonucleotide modifications
- Manufacturing in controlled environment
- Qualified cleaning procedures
- Proven processes to avoid human DNA- and cross contamination
- Established solutions for complex forensic applications
