BioSpring is your experienced and reliable partner for commercial therapeutic oligonucleotide manufacturing.
Our facilities are FDA-inspected for commercial manufacture and analytics of oligonucleotide APIs, and GMP-certified by the German authorities. We are officially registered as an API manufacturer with the FDA, EMA, and PMDA.

Dedicated commercial manufacturing suites, multiple hundred kg annual manufacturing capacity allows for seamless and flexible onboarding of your commercial program.

Our experienced commercial readiness team supports you with the following services in preparation of your market authorization:

• Process characterization
• Range finding studies (e.g., DOE, OFAT)
• Critical parameter determination
• PPQ batch manufacture
• Cleaning validation
• Risk assessments
• Raw material & analytical method validation
• FEU qualification
• Continuous process verification
• Life cycle management