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Our foundation Committed to highest quality standards

Quality matters.

Strict adherence to the highest quality standards defines who we are, whether manufacturing nucleic acids for R&D or commercially manufacturing and analyzing nucleic acid active pharmaceutical ingredients (APIs) and drug products. We operate according to the current Good Manufacturing Practices (cGMP) as regulated by the German authorities, Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceutical and Medical Devices Agency (PMDA). No matter where you are at in the drug development process, we work alongside our clients to achieve our shared vision of a safer and healthier world and deliver the quality you require.

Covering the Entire Drug
Development Lifecycle

Infographic: Development Lifecycle

Quality System for Commercial & Clinical Therapeutic Oligonucleotides

Since 2007, our manufacturing facilities and analytical laboratories have been Good Manufacturing Practices (GMP) certified by German authorities. Our commercial GMP quality system strictly adheres to the GMP standards of regulatory agencies, including the FDA, EMA, and the PMDA.

GMP Certificate

In 2016, we successfully completed our first FDA pre-approval inspection (PAI) for an analytical oligonucleotide program. As of 2020, BioSpring is a commercial, FDA-inspected manufacturer for oligonucleotide APIs. In addition, we are a registered API manufacturer with the FDA and PMDA.

FDA Certificate of Registration
PMDA Certificate of Registration

We are ISO13485- and 9001-certified, and FDA 21 CFR 820-compliant. Our quality system ensures the consistent quality that is necessary for the manufacture of commercial diagnostic oligonucleotides.

Regulatory Support for CMC Sections

IND/IMPD and NDA/MAA Filing Support

Regulatory filings are a crucial step towards market approval, supplying important information about the drug’s safety, efficacy, quality control, and manufacturing process. As one of the most experienced CDMOs in the therapeutic nucleic acid industry, you can rely on our regulatory expertise, quality assurance teams, technical support, and post-approval support to help you navigate the complex regulatory landscape.
Driven by our technical and regulatory experience we provide CMC support for sections 1 through 7. BLA-filing assistance/support can also be offered. See below for a full list of our support services:

Regulatory Support for Filing

  • Technical writing (and maintenance) of dossier sections
  • Review of dossier supmissions (IND, NDA, BLA, DMF...)

Documentation Support for:

  •  E&L risk analyses for late stage of marketed products
  • Nitrosamine assessments
  • Comprehensive assessments or general statements for processes/products

Additional Support

  • Developing strategies for implementing requirements of ICH M7 Guideline (Assessment and Control of DNA reactive impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk)
    • Implementation and further development and improvement of purge factor approach
    • Applied approach to other carcinogenic impurities 
  • Support for Tox assessments for APIs
Unleash the full potential of your next oligonucleotide program! Contact us
Want to know more on our quality systems and how we can support your filings?

Get in touch