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BioReliance provides testing services for regulatory compliance during product development. They have facilities in multiple locations, including USA, UK, Japan, India, Singapore.


Biopharmaceutical Services (Biosafety Testing) [1]

Cell Line Characterization

Tests to identify the cell line and assess the genomic stability and purity of the cell line

Virus Bank Characterization

Raw Material Testing

In order to avoid the risk of contamination, animal derived products are tested to validate the purity and quality.

Analytical Services for Biologics

Next Generation Sequencing

Bulk lot Release Testing

Final Product Release Testing

Viral Clearance Studies

Biorepository Services

Short and long term storage facilities for biological samples are available. The types of samples that can be stored include: serum, plasma, viral stocks and eukaryotic and prokaryotic cells. Stringent protocols ensure the safe storage of samples.

Immunoassay & Cell Based Assays

Biopotency testing, ELISA and ECL assays, and method transfer and validation are available for testing pharmaceutical agents.

A number of technologies are performed including plate readers (absorbance, fluorescence intensity, luminescence), FACS, Meso Scale Discovery, and microscopy.


Product Characterization

Physiochemical and Structural Assays

Offers a variety of assays and platforms for evaluating drug quality and customization is available.

Binding Assays

Tests the activity of Fc receptors to evaluate therapeutic antibodies

Potency and Bioassays

To ensure product quality, products are tested for reliability, stability, and consistency

Stability and Degradation Programs

Stability studies are performed on biologics to determine effects of environmental conditions.

Lot Release Testing

Verification history