BioReliance
Contents
- 1 BioReliance
- 1.1 Services
- 1.2 Biopharmaceutical Services (Biosafety Testing) [1]
- 1.2.1 Cell Line Characterization
- 1.2.2 Virus Bank Characterization
- 1.2.3 Raw Material Testing
- 1.2.4 Analytical Services for Biologics
- 1.2.5 Next Generation Sequencing
- 1.2.6 Bulk lot Release Testing
- 1.2.7 Final Product Release Testing
- 1.2.8 Viral Clearance Studies
- 1.2.9 Biorepository Services
- 1.2.10 Immunoassay & Cell Based Assays
- 1.2.11 A number of technologies are performed including plate readers (absorbance, fluorescence intensity, luminescence), FACS, Meso Scale Discovery, and microscopy.
- 1.3 Product Characterization
BioReliance
BioReliance provides testing services for regulatory compliance during product development. They have facilities in multiple locations, including USA, UK, Japan, India, Singapore.
Services
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.