Biologics identity testing

Biologics identity testing is the set of methods used to characterize and allow the release of substrates and biopharmaceutical drug products. Depending on the nature of the products ( i.e. cells, vectors, proteins), different guidelines and expectations are relevant with regards to acquiring an enhanced knowledge of biological manufacturing processes and drug products, and consequently set the appropriate specifications.

To achieve this goal, assays must be developed and validated in accordance with ICHQ2R2 recommendations and suitable guidances issued by regulatory authorities (EMA, FDA, etc.). 

Biologics identity tests ensure that starting material (biological substrates) and manufactured products are the expected ones through methods using flow cytometry, qPCR, karyotyping, fingerprinting, sequencing… They all belong to Product Characterization assays.

Evaluating if storage may impact in any way the efficacy of the product is crucial. Thus, as a key part of biologics identity testing, stability must be assessed and setting the right tools  as soon as possible is necessary to evaluate the suitable storage conditions and determine an expiry date.  

The manufacturing process itself may impact the genetic stability of the drugs, testing must be therefore included for an appropriate evaluation of how biological products may  evolve genetically, allowing for increased safety and efficacy.