Activity areamAbs & RP
Monoclonal antibodies and recombinant proteins: from screening to pharmaceutical release
Substances produced using genetic recombination are a heterogenous body of pharmaceuticals based on genetic editing on cells. They are further used as substrates for the manufacture of these advanced therapeutics.
The Clean Biologics group has taken part in their development through Biodextris and Clean Cells, companies specializing in the quality control testing of these biopharmaceuticals according to GMPs with an extended panel of assays used from the screening stage to the commercial phase.
Monoclonal antibody screening support
Clean Cells has developed numerous methods used for the early screening step, helping customers select the most suited validated methods used to assess antibody-dependent cytotoxicity (“Antibody Dependent Cellular Cytotoxicity” or ADCC assays), or complement-dependent cytotoxicity (Complement Dependent Cytotoxicity or CDC assays)
Since 2021, Biodextris brings its expertise using diverse bioprocesses to the Clean Biologics group. It is built on extensive technical and regulatory experience from numerous partnerships with clients all over the world.
The team at Biodextris supports sponsors in developing the best-suited upstream and downstream processes for recombination-based products. It is performed through close monitoring and control of key parameters to reach increased yields while ensuring the highest quality and safety for your candidates.
Biodextris also shows great knowledge and experience in scale-up and process transfer stages to reach the most direct path to clinical and commercial.
For additional information please visit our Manufacturing and Development webpage.
Manufacturing lots and banks according to Good Manufacturing Practises
Clean Cells has set up dedicated GMP manufacturing laboratories for the generation of mammalian and microbial cell banks and has gathered a large experience with suspension and adherent cell lines, including the production of numerous CHO cell banks (Chinese Hamster Ovary) typically used for the generation of monoclonal antibodies.
Biodextris complements Clean Cells’ manufacturing capabilities with multiple GMP and non-GMP production suites to accommodate needs ranging from milligrams to tens of grams of purified protein per lot. This capacity is coupled with highly qualified infrastructures and extensive knowledge and application of cGMPs, thus ensuring quality and safety of products.
For additional information please visit our dedicated webpage.
GMP-compliant quality control testing
Clean Cells is a worldwide leader in the regulatory quality control testing of clinical and commercial lots.
We take part in the full characterization of monoclonal antibody and recombinant proteins manufacturing chains at key-steps, from starting material to final lots.
Please visit our dedicated webpage for more information.