A combined long-term chemical and biological know-how supported by dedicated suites and investments, positions Cerbios as a CDMO of choice for ADCs.

Cerbios is one of the front-runners and a recognized partner for the development and manufacturing of Antibody Drug Conjugates (ADCs).

The unique possibility to develop and manufacture your ADC and its components (mAb, toxin /payload, conjugate) in a single site in Lugano brings a tremendous advantage to the speed and quality of the Drug Substance.

Process development and manufacturing of tox and first clinical batches with one sole partner is the real “one-stop-shop” solution to improve effectiveness, without compromise.

We can follow you with the toxin, mAb and conjugation manufacturing from early stage development up to and including commercial supplies.

Cerbios further expands its offer of services being part of PROVEO Alliance, with extended capacity for mAbs (at AGC Bio) and fill- finish services (at Oncotec).

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

SPECIFIC SKILLS

Developing and manufacturing Antibody Drug Conjugates needs chemical and biological skills but not only.

The array of expertise in ADCs bioconjugationincludes:

  • Traditional Site-specific (Thiomab-Like)
  • Glycan conjugation (Synaffix)
  • Enzymatic (Tgase)
  • Traditional stochastic on Lysines and Cysteines
  • Flow conjugation
  • Expertise with multiple payloads conjugation (e.g. Maytansinoids, Auristatins, PBDs, Calicheamicin)

Unique in the CDMO landscape Cerbios can offer cGMP facility for non-cytotoxic payload conjugation to ensure full segregation from cytotoxic activities.

SERVICES AVAILABLE

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

Antibody Drug Conjugates are very complex Drug Substances that require a broad range of skills which Cerbios includes in the services provided…

  • Early stage development to commercial manufacturing
  • DoE and/or QbD Process Development for cGMP manufacturing up to the commercial stage
  • Cytotoxic and non cytotoxic ADCs
  • Toxin and toxin-linker (see also HPAPIs services)
  • Conjugation 
  • mAb development from cloning the gene to cGMP production
  • Option to have the full process at a single site in Lugano (mAb, toxin, conjugation, analytics)
  • Customising analytical methods development and validation using a broad panel of in-house methods and technologies:
    • HPLC-SEC, RP, HIC, PLRP, CE, HILIC
    • nanoDSF / DSC, ELISA, CIEF, CE-SDS
    • Mass spectrometry (conjugation sites, payloads distribution, mAb modifications)
  • Small scale proof of concept ADCs for early stage development studies
  • Formulation studies with low volume nanoDSF

PRODUCTION CAPACITIES

Two fully independent cGMP manufacturing facilities for cytotoxic and non-Cytotoxic bioconjugates:

  • mAb development (from cloning the gene to commercial production)
  • Option to have the full service in one single site in Lugano (mAb, Toxin, Conjugation, Analyitcs)
  • Toxin, payload and Conjugation capacities from early stage to commercial in one site
  • Class D and C areas
  • 5L-200LSingle-Use reactors
  • Single Use Purification equipments:
    • TFF
    • Bio-Chromatography
  • Bioburden controlled processes
  • Dedicated Freezing equipment for pre-formulated Drug Substance