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Biosimilar testing services from SGS – a complete range of solutions to help you with every aspect of biosimilar development.

Life Science lab

Biosimilar development is unlike that of a novel biotherapeutic or generic drug, which is why you need accurate analysis at every stage. From determining the exact sequence, structure and quality attributes of the originator to comparative head-to-head biosimilarity testing of the biosimilar with the originator, our biosimilar testing services provide vital analytics. 

Our integrated biosimilar development platform is based on a step-by-step approach to help you move seamlessly through the critical stages of development – from product characterization and biosafety testing, to full comparability studies and clinical trials, including bioanalytical and bioassay.

Why choose biosimilar testing services from SGS?

We can help you:

  • Meet regulatory requirements with physicochemical characterization. Using high-end mass spectrometry and ancillary techniques, we identify the primary and higher-order structure of glycoproteins and proteins, including monoclonal antibody products, at critical stages of development, helping you fulfill ICH Q6B requirements
  • Ensure that your cell cultures, virus stocks and final products are certified free from contaminating agents, such as endotoxins and viruses through biosafety testing. We offer complete cell bank and bulk harvest characterization for biosimilars, including cell banks, raw materials of animal origin, unprocessed/processed bulk harvests, and batches of clinical product
  • Gain quick results for strategic decision-making with our bioanalysis and clinical trials. Our services are specifically tailored, enabling non-clinical in-vitro comparability testing, pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modeling studies and critically important immunogenicity screening during clinical studies

World-leading biosimilar testing expertise

As a world leader in biosimilar testing, we offer the experience and expertise to handle all of your testing requirements – from one source. Our biosimilar services provide a dedicated point of contact and include regulatory advice and consultancy to aid you through the process. 

We have invested in a global laboratory network, providing centers of excellence in biopharmaceutical services and worldwide clinical research facilities, including a clinical pharmacology unit and seven offices across US and Europe. As a result, we can perform the complete range of laboratory analysis and clinical trial studies, including comparative studies and clinical efficacy trials, to demonstrate the biosimilarity of your molecule.

To discuss how our biosimilar testing services can help you, contact us today.