With experience since 1993 in handling HPAPIs in accordance with cGMP, Cerbios is highly qualified as a Contract Development and Manufacturing Organisation (CDMO) for your HPAPIs from early stages, through clinical trials to commercial supply. 

Cerbios is the ideal and reliable partner to support you at all stages of the development of your New Chemical Entity (NCE) or advanced intermediates. 

The application of Design of Experiment (DoE) and Quality by Design (QbD) approaches, combined with a professional Project Management approach and team are paramount to the success of Drug Substance development.

Cerbios provides a comprehensive CMC service to support all aspects of the development, registration and commercial manufacturing of your molecule. 

“Our client has continuous transparency on the development of their API throughout the entire programme and will have direct communication with each member of the project team”.

CDMO - HPAPIs - Cerbios-Pharma SA

SPECIFIC SKILLS

CDMO - HPAPIs - Cerbios-Pharma SA

Developing and manufacturing modern HPAPIs requires chemical skills but not only these.

  • Process development applying a DoE and/or QbD approach 
  • cGMP manufacturing from small to large scale (5 grams – 30 kgs / batch)
  • Containment: according to Category 3 and 4 according to SafeBridge® Standard (OEL < 10 ng/m3)
  • Continuous Flow Chemistry applied to HPAPIs
  • Particle size engineering
  • Industrial chromatography (PLC and Biotage)
  • Photoreactions

Handling of different classes of APIs including 

  1. Cytotoxic molecules
  2. COPDs
  3. payloads for ADCs
  4. Vitamin D Derivatives
  5. CNS compounds

and more.

SERVICES AVAILABLE

ADCs - Antibody Drug Conjugates - CDMO Services - Cerbios-Pharma SA

Cerbios provides full CMC support for your lead compound, from the development stages to commercial supply. On top of traditional chemical and analytical development activities, Cerbios can provide you with:

  • KSM identification and management
  • Supply chain management
  • Potency and toxicity assessment
  • Safety assessment
  • Strategic industrial and regulatory manufacturing consultancy
  • Genotoxic impurities identification
  • Manufacturing and analytical methods validation
  • Stability testing
  • Impurities characterisation
  • Full regulatory support

PRODUCTION CAPACITIES

Category 3-4 HPAPI production units, according to SafeBridge® categorization:
5 units fully isolated and contained according to SafeBridge® standards.

cGMP unit

10 – 100 gm / batch

cGMP modular unit

200 gm – 2 kgs / batch

cGMP unit **

5 – 30 kgs / batch
** New, operational in 2020

Non cGMP unit

up to 50 gm / batch
For Drug Product development

Non cGMP unit

up to 100 g / batch
For Drug Product development or Tox studies
HPAPIs - Capacity - Cerbios-Pharma SA