Development and manufacturing of Pharmaceutical APIs since 1979 and HPAPIs (High Potency Active Pharmaceutical Ingredients) according to cGMP since 1994.

Cerbios is a highly qualified supplier of pharmaceuticals APIs and HPAPIs, which has consolidated over the years strong competences in Process Development and commercial cGMP Manufacturing for world-wide distribution

“Fostering Values though Innovation©” means to us continuous investment in resources, people and technologies, to offer our clients excellence in our services and products.

Over the years, Cerbios has made substantial investments in infrastructure to strengthen and further extend its activities and services in the field of HPAPIs.

All containment facilities are designed and based on a modern zone concept with pressure cascades, airlocks and access controls.

Our comprehensive know-how and expertise acquired in the past decades is available to our partners looking for a reliable CDMO organization providing full CMC assistance.

A professional regulatory support and project management from our team is paramount to all activities. Specific competences are summarized below

CONTINUOUS FLOW CHEMISTRY

Cerbios has already experienced first HPAPI product commercial scale manufacturing by applying this innovative technology as well as achieving its approval from Regulatory Authorities.

Continuous flow chemistry, and its application in micro-reactor systems, is available at our Cerbios site to enable and unlock the advantages of this technology for R&D purposes as well as for cGMP production of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).

Process intensification techniques, combined with micro-reactors, have boosted several cutting-edge advantages that overcame specific batch system blind spots, such as:

  • Improved product quality
  • Negligible scale-up effects
  • Ultra-short residence times have drastically reduced production time.
  • Lower waste levels are conducive to “Green” manufacturing.
  • Use of hazardous material in small volumes lowered HSE risks
  • Better control of process parameters with reduction of energy use.
Continuous Flow Chemistry - Cerbios-Pharma SA

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Liquid Chromatography - Cerbios-Pharma SA

Preparative HPLC for GMP manufacturing operations in high containment allow purification of up to Safebridge category 4 HPAPIs

This well-known technology, normally used during the early-stage development of New Chemical Entities and payloads for ADC, is available at the Cerbios site for lab-scale method development operations and for industrial-scale purification of Highly Potent Active Ingredients (HPAPIs) in a cGMP environment, qualified for high containment up to category 4, (OEL < 30 ng/m3), according to the Safebridge categorization system.

The setup  of the Cerbios’ GMP manufacturing units allows for the purification of batches of up to 5 kg, which in most cases is suitable for the commercial-scale production of potent compounds. The technology is offered by Cerbios in combination with the production of HPAPIs and not as a stand-alone service.

ADVANTAGES

The key advantages of using this purification method are: 

  • Higher yields compared to crystallization.
  • Quicker turnaround with positive impact on development phases.
  • Potent control strategy to meet target quality requirements of desired compound
  • Possibility to purify oily or low fusion products.
  • Possibility to purify products that do not crystallize because of specific impurity content.
  • Possibility to isolate impurities during the same run of product purification.
  • Trade secret barriers