Since 2007 BioSpring production and quality control of APIs has been certified by the Regierungspräsidium Darmstadt’s GMP.

GMP has one purpose and one purpose only: To protect patients from ineffective drugs or drugs with unacceptable side effects.

In Europe, only governmental agencies have the right to certify that companies’ production meets the GMP standards. For the protection of patients, all drug manufacturers and, since 2006, all producers of APIs (active pharmaceutical ingredients) are obligated to adhere strictly to the requirements set out in the GMP rules and standards. The GMP rules and standards are not merely meant to guarantee the production of safe and effective medications; they also require the production of drugs and APIs can be fully tracked from the staring materials to the final product without a gap (traceability). This is the only way to ensure that the cause of any defects can be identified and precautions can be taken to prevent the return of such defects. In practice, GMP thus means the complete documentation of all manufacturing and analysis steps.

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BioSpring GMP Manufacturing

 GMP certificate
Clean room (movie)
GMP manufacturing
Good Manufacturing Practice
Analysis and quality assurance

Sanofi and BioSpring cooperate on the field of therapeutic oligonucleotide manufacturing
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