With over 40 years of experience, Cerbios is a leading company in the development and manufacture of biopharmaceutical active ingredients, such as living bacteria, to strict GMP quality standards.
It all started with SF68®, our proprietary probiotic active ingredient, which we have been producing to a cGMP pharmaceutical grade since 1978.
Over the years, Cerbios accumulated further experience in manufacturing probiotic and live biotherapeutics for its customers worldwide.
Since 2008 Cerbios has been manufacturing the Drug Product version of the proprietary probiotic in the form of hard gelatin capsules in glass bottles, sold in several countries.
Providing not only manufacturing, but also assistance for CMC and regulatory challenges, Cerbios is the gateway to transforming your microorganism into a drug.
Thanks to a longstanding presence in the pharmaceuticals ingredients market of biological origin, Cerbios is the right partner to navigate the regulatory challenges behind the development of Live Biotherapeutics.
Live Biotherapeutics development and manufacture as Drug Substances requires a broad range of skills that Cerbios can offer such as:
Strain selection and genetic study
cGMP media
Fermentation & stabilization studies
Downstream process
Analytical methods development and validation
Use of DoE and QbD in the various project stages
CMC and regulatory assistance is provided all the way, with the common aim of achieving an efficient, reproducible and cost-effective manufacturing process.
The Cerbios facility is cGMP certified by Swissmedic for clinical and commercial supply. Moreover, our quality system has been approved by the US FDA since 1998. Installed capacity includes:
2 x 4,000 liter microbial fermentation capacity, and counting
Centrifuge
Deep-freez chamber
Freeze-dryer (through qualified partnership)
Pasteurizer
Spray-dryer
Hard gelatin capsule filling
Bottle filling, labeling and packaging
Should there be specific needs, Cerbios is open for extensions, in collaboration with partners interested in keeping the entire supply chain, Drug Substance and Drug Product on the same site.
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