Biosimilars

We are well-versed in the unique considerations for supporting biosimilar studies and have successfully validated and implemented assays for these therapeutics, from immunogenicity and pharmacokinetic testing of clinical samples to characterization and stability testing for drug manufacturing.

Our scientists have experience supporting biosimilar studies across a range of assay types including but not limited to:

• Ligand Binding Assays / Immunoassays
• Cell-based Assays
• Molecular Assays
• Mass Spectrometry

In addition to preclinical and clinical testing, BioAgilytix has successfully supported biosimilar manufacturing through the development and phase-appropriate implementation of characterization, potency, and stability testing within our experienced CMC Bioanalytical teams. 

Biosimilars are a diverse category of therapeutics covering many different mechanisms of action and disease indications. As such, partnering with a lab that can provide a range of methods and instrumentation is critical for addressing the bioanalytical needs of a biosimilar program. BioAgilytix has an extensive suite of technology platforms and experience leveraging these resources for PK, biomarker, cell-based, and immunogenicity (ADA, NAb) assays to support biosimilar development. Some of our commonly used instruments include:

• ELISA 
• MSD
• Gyrolab
• Protein Simple Ella
• Luminex
• LC/MS

Working with BioAgilytix allows you to customize your CMC analytical needs for your potency assay development, drug characterization and release testing.

Biosimilars represent a rapidly expanding global market and BioAgilytix is committed to supporting this growing therapeutic market by bringing together the best scientists, technologies, and processes to rapidly develop and deliver reliable, high-quality data for a range of biosimilar modalities such as monoclonal antibodies and protein therapeutics. We have direct experience analyzing samples from rodents, humans, and non-human primates under non-GLP, GLP, and GMP regulations.

Our scientific teams continue to stay involved in the latest industry and regulatory aspects of supporting biosimilars and other investigative therapeutic modalities. Our teams have contributed to a number of publications specific to biosimilars, including:

Recommendations for the development and validation of neutralizing antibody assays in support of biosimilar assessment. Learn more

Meeting the rigorous demands of biosimilar pharmacokinetics. Learn more 

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development. Learn more 

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development. Learn more 

For additional publications and presentations on a variety of assays, modalities, and regulatory topics, browse our collection here.