Product characterization

Biologics product characterization is one of the fastest growing areas within the biotech sector pharmaceutical market.  New biologics and biosimilar products require a combination of physicochemical and biological characterization.  The data generated will be used to demonstrate to the regulatory agencies that the products are well understood. Most importantly, if you make changes to your products between clinical trials you will be expected to perform product comparability to demonstrate the impact (or lack of) of the changes that you have made to your product.  This can be generated by clinical trial bridging data, pre-clinical comparability or, and ideally because of speed and cost, analytical product characterization.

Given the size and complexity of biological molecules such as monoclonal antibodies, cellular therapies and vaccines, sophisticated methodologies must be applied in combination or orthogonally.  These often include mass spectroscopy, fluorescence spectroscopy, immunoassays, SDS-PAGE, particle and aggregate methods such as Field Flow Fractionation (FFF), dynamic light scattering (DLS) or Nanoparticle tracking analysis (NTA).  Application of these methods allow a broad picture or profile of the product to be developed.  In some cases, the characterization methods apply such insight that they are transferred to quality control laboratories with the methods entered onto product specifications.

GRA has many years of experience in the characterisation of biologicals including vaccines, monoclonal antibodies, proteins and cellular products.  We work closely with characterization partners globally to carefully select and guide characterization efforts.  Furthermore, GRA has generated sections of dossiers and comparability documents for clients that have undergone successful review by US and European regulatory bodies.