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From Validation to Value Commercial Manufacturing & Process Validation Services
Seeking a long-term commercial partner?

We are your trusted and experienced global partner for large-scale, commercial manufacturing of nucleic acids.

Our innovative technology and quality processes ensure that we deliver exceptional reproducibility and on-time material. Our dedicated team of expert chemists, technical operation leaders, and project management will guide you through a seamless process wherever you are at in your commercial program. Our steadfast commitment to sustainable manufacturing and continuous improvement makes the transition to BioSpring a clear choice.


Nucleic Acid Manufacturing

Commercial Manufacturing & Process Validation Services

Our manufacturing facilities are FDA-inspected for both the commercial manufacture and analysis of oligonucleotide APIs. We are also GMP-certified by the German authorities.

We are officially registered as an API manufacturer with the FDA, EMA, and PMDA. Our multiple dedicated commercial manufacturing suites and hundreds of kilograms of annual manufacturing capacity allow for seamless and flexible onboarding of your commercial program. 

BioSpring has been validating nucleic acid drug substance manufacturing processes since 2016. We have successfully completed multiple process validation campaigns (multi-kg batch sizes) for industry-leading clients and are actively manufacturing commercial batches for market supply.

Supporting your therapy's market authorization:

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


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FDA-inspected and > 17 years cGMP-certified Find out more about our quality system
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Analytical Services Complementing your program Find out more about our analytical services
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Dedicated Project Manager Ensuring success through collaboration Find out more about our project management services