More than 20 years of experience in successfully developing and manufacturing biotechnology products based on proprietary license free CHO cell line and over 10 year in Bio-conjugation.

Cerbios’ state-of-the-art cGMP production facilities comply with international regulatory requirements and guarantee a Swiss quality assurance system with extensive technical and regulatory expertise. A multidisciplinary team of experts from the R&D, Manufacturing and Quality Assurance departments involved from early process development to cGMP manufacturing enables a flawless transition from preclinical to advanced clinical phases and commercial.

Moreover, process development activities are performed using a QbD approach with the adoption of DOE coupled to PAT instrumentation to allow full process characterization minimizing project risks. Advanced analytical competencies using state-of-the-art instrumentation necessary for in-depth biopharmaceutical product characterization are available including formulation development. Cerbios’ fully equipped Quality Control laboratories support all projects from method development through method validation to cGMP batch release. 

Biological Competencies - Cerbios-Pharma SA

CHO PLATFORM

Competencies - Biotechnological - Cerbios-Pharma SA

Cerbios established its own CHO expression platform based on a proprietary CHO-K1 cell line and expression vectors which, combined with upstream, downstream and analytical expertise, ensures high product quality right from early project phases. Using state-of-the-art imaging devices, Cerbios is able to offer single clone isolation with full documentation support in order to meet regulatory guidelines. Cerbios CHO platform provides high process productivity, is first line choice for cGMP manufacturing and is proven with monoclonal antibodies and recombinant proteins. The expression platform is offered royalties-free for CDMO projects and products to be manufactured at Cerbios with no additional burdens for our clients.

BIOCONJUGATION

Taking advantage of its state-of-the-art infrastructure, Cerbios can offer a single entry point for the manufacturing of ADC Drug Substance and any of its components (mAbs, payloads and toxins); all in one site, at Cerbios main plant in Lugano.

As a natural evolution of established competencies in process development and cGMP manufacturing of Monoclonal Antibodies, recombinant Proteins and Highly Potent Active Ingredient’s (HPAPIs), Cerbios expanded its activities in the Bioconjugation area for the manufacturing of Antibody Drug Conjugates (ADCs) and Protein Drug Conjugates (PDCs).

Cerbios has the flexibility to handle an end-to-end manufacturing solution or integrate into the existing sponsor’s supply chain. In addition, it has the unique set-up to manufacture ADCs with both cytotoxic  and non-cytotoxic payloads in different and dedicated conjugation suites.

The collaboration within the PROVEO Alliance, further speeds up the commercial development phase for our partners and maximizes the supply-chain efficiency.