Biologics testing

Biopharmaceuticals are potent products requiring specific Biologics testing to ensure safety for patients and workers, while securing the expected medicinal effects. These tests are typically divided between biosafety testing, which aims at detecting biological contaminants during production and in finished products, and characterization, aiming at discriminating physico-chemical attributes and evaluating both identity and potency.

Biologics testing is performed under the authority of regulatory agencies, such as the European Medicine Agency (EMA) or the Food and Drug Administration (FDA), which issue guidelines specifying quality control expectations when working within Good Manufacturing Practices (GMP).

Clean Cells is a long-standing biologics testing expert with an extensive cGMP track-record. With 24 years of experience working as contract laboratory with companies around the world, our team has developed and validated hundreds of assays applicable to the whole range of biopharmaceuticals in non-clinical (R&D), clinical and commercial (GMP) settings. 

Our expertise allows for the rapid determination and execution of the appropriate testing rationale, most closely adapted to your bioloical product. Our panel offer flexible and cost-effective strategies to answer regulatory expectations while ensuring the highest level of safety for patients.

Biosafety testing

Biopharmaceuticals are medicinal products manufactured from living material: as such, they may carry adventitious or endogenous contaminants. An essential part of biologics quality control testing, biosafety detection of agents uses diverse methods to prevent any hazard during production or in further handling. Generic assays using permissive cell lines or in vivo testing are non-specific approaches to detect various contaminants (viruses, retroviruses and mycoplasma), while qPCR and dPCR tests provide high-performance detection tools targeting specific agents. Sterility, mycoplasma and mycobacteria testings by culture completes the biosafety panel of assays expected within biologics testing.

Clean Cells is a world-leader contract laboratory (CRO) for biosafety services and is a PCR specialist with hundreds of references for specific contaminant discrimination.

Characterization

Some analytical methods are fundamental to determine the expected attributes of the biopharmaceutical: these biologics analytics are known as product characterization. Characterization commonly refers to identity, purity and potency assays together with generic physico-chemical tests. 

International standards define the analytical framework used for product characterization as part of biologics testing development and validation. In particular, the International Council for Harmonisation (ICH) guidelines govern the expected parameters (accuracy, precision, specificity…) during validation to ensure tailor-made characterization. 

Our panel of biologics characterization tests include cytotoxicity assays available in cGMP format, most notably for the potency evaluation of monoclonal antibodies at R&D or clinical & commercial stages.

Please reach out to our team of experts to define the optimal biologics testing plan for your product.

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