Product characterization is a set of methods aimed at testing critical attributes in a drug as part of biologics testing. In accordance with regulatory guidelines, biopharmaceuticals are characterized in terms of physico-chemical qualities and thus tested for impurity, potency, and identity & genetic stability. Drug characterization assays need to go through extensive qualification and validation to ensure that they meet the required quality and safety standards, as per the International Council for Harmonisation (ICH) recommendations.
As a quality control specialist, Clean Cells has built a portfolio of product characterization services complementing biosafety testing services. Our fully validated characterization assays – according to ICH Q2R2 recommendations- can be used in GMP settings.
Customized drug characterization testing can be implemented or fully developed by our analytical development team to fit specific product or process requirements.
Because impurities could affect the safety of patients and the efficacy of a treatment, impurity testing is the section of product characterization which ensures that no residual material from bioprocess – remains in a given sample.
To reach a suitable level of purity, biologics need to be tested for impurities (i.e. Host cell Proteins, Host cell DNA, DNAse, antibiotics…) at various stages of production.
Potency testing determines the functional activity of biopharmaceuticals and is an essential metric to prove efficacy compared to a reference standard and to ensure a suitable activity of the manufactured product before injection in patients. Such potency assays are very diverse depending on the molecule of interest and how it is possible to address directly or indirectly the question of its functionality. Classically, potency assays used for Drugs characterization includes bioassays which are specific to a considered substance.
For instance, ADCC (antibody dependant cell cytoxicity) is a gold standard in the characterization and the release of monoclonal antibodies batches.
Biologics are often based on recombination techniques which exploits DNA and cell substrates to manufacture the desired substance. As part of drug characterization, biologics identity testing and genetic stability testing ensure that substrates and drugs are matching expected identification attributes through genetic techniques (PCR, karyotyping, etc.).
Clean Cells have collaborated with worldwide customers involved in diverse biopharma projects. We combine technical expertise in bioassays, great flexibility and detailed knowledge of regulatory expectations to provide bespoke product characterization assays through analytical development.
Reach out to us for more information on assay development.
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