GMP Manufacturing
GMP-certified since 2007 and FDA-inspected for the commercial manufacture of oligonucleotides, BioSpring’s APIs have by now been used in over 250 clinical studies worldwide. We support our clients from early small-/mid-scale manufacture of their therapeutic oligonucleotides to late-stage clinical and commercial manufacture, including all related analytical activities. Our single-source services are designed to accelerate your therapies past market approval and onto commercial realization.
Our state-of-the-art facilities with cutting-edge technologies for nucleic acid synthesis and downstream processing are formulated with reproducible product quality and patient safety in mind. Multiple clean rooms provide maximum flexibility for continuous and parallel manufacturing of cGMP-grade nucleic acids.
Overview of Services
- GMP manufacturing for clinical Phase I – III
- Process validation and commercial manufacture
- Manufacturing of nucleic acids for R&D, as well as lead candidate screening and development
- Process development – more than 140 successful programs each year
- Scale-up, scale-down and process transfer
- Preclinical non-GMP batch manufacture
- Regulatory tox batch manufacture
- Generation of reference standards
Facilities and Capacities
- Annual manufacturing capacity: multiple-hundred kg
- nmol/µg to multiple-kg pre-clinical, GMP, and commercial manufacture
- 9 separate high-class GMP manufacturing trains, plus dedicated areas for synthesis and lyophilization; additional clinical and commercial manufacturing trains in planning
- Next-generation OligoProcess and OP400 synthesizer platforms
- Dedicated commercial manufacturing trains
- Dedicated preclinical manufacturing areas
- GMP compliant QC-laboratories for in-process and release testing
