Cerbios offers high quality custom-made programs for recombinant therapeutic proteins.

From cloning to cGMP production, Cerbios meets your product development and manufacturing requirements for recombinant proteins and monoclonal antibodies (mAbs).

Our aim is to enable our clients to reduce the time required to develop robust and scalable manufacturing processes in order to produce cGMP biomolecules for clinical trials and commercial supply.

Cerbios’ state-of-the-art cGMP production facilities comply with current GMP and guarantee an internationally certified quality assurance system with extensive technical and regulatory expertise.

A competent and flexible team is available to help our partners achieve their project timelines and quality objectives. 

Protein & Antibodies - CDMO - Cerbios-Pharma SA

SPECIFIC SKILLS

Protein & Antibodies - CDMO - Cerbios-Pharma SA

We are your partner for the successful development and manufacturing biotherapeutic products with an array of specific skills:

  • High expressing proprietary CHO-K1 cell line and vector;
  • Handling mostly used mammalian cells (CHO-K1, CHO-DG44, PER-C6, NS0) for protein expression;
  • Platform form antibody expression and purification;
  • Three step Process Development (Screening > Optimization > Robustness) using QbD and DOE approaches;
  • State-of-the-art analytical tools for monitoring the Product Quality Profile;
  • Seamless phase transition adopting a FMEA risk analysis;
  • Multipurpose cGMP facility.

SERVICES AVAILABLE

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

Cerbios multidisciplinary skilled team provides a complete panel of services for biotherapeutic product development and manufacturing:

  • Mammalian single clone generation: including vector generation, cloning, transfection, single clone isolation and RCB generation.
  • R&D Process development:
    • Upstream /Downstream process development
    • Process scale up
    • Full Analytical method development
    • Formulation development
  • Master and Working Cell Banks (MCB and WCB) manufacturing and storage 
  • cGMP Drug Substance batch manufacturing of recombinant proteins including mAbs
  • Generation and qualification of reference standards
  • ICH stability studies 
  • CMC Regulatory affairs support for product registration.

PRODUCTION CAPACITIES

Cerbios Development laboratories and cGMP facility are quipped with the appropriate equipment to fulfil your needs.

  • High resolution whole well imaging system
  • Small scale parallel Bioreactors for process development
  • Bioreactors up to 40L for scale up in Batch, Fed-batch or perfusion modes.
  • Single-Use TFF equipment
  • Purification and filtration equipment;
  • DSF/SLS/DLS instrumentation for formulation development
  • LC-MS for in depth protein characterization
  • Analytical equipment for full product characterization
  • Cell culture bioreactors up to 100L upgradable to 500L or any size with a preffered partners;
  • Downstream equipment: Depth filtration harvest, Chromatography, Tangential Flow Filtration, Viral filtration and bulk filling;
  • Quality control equipped with HPLC/UPLC-DAD/FLD, CE-SDS, cIEF, cell-based potency testing equipment, osmometer, ELISA and qPCR
Protein & Antibodies - CDMO - Cerbios-Pharma SA