BioReliance
Contents
[hide]- 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[edit | edit source]
BioReliance provides testing services for regulatory compliance during product development. They have facilities in multiple locations, including USA, UK, Japan, India, Singapore.
Services[edit | edit source]
Biopharmaceutical Services (Biosafety Testing) [1][edit | edit source]
Cell Line Characterization[edit | edit source]
Tests to identify the cell line and assess the genomic stability and purity of the cell line
Virus Bank Characterization[edit | edit source]
Raw Material Testing[edit | edit source]
In order to avoid the risk of contamination, animal derived products are tested to validate the purity and quality.
Analytical Services for Biologics[edit | edit source]
Next Generation Sequencing[edit | edit source]
Bulk lot Release Testing[edit | edit source]
Final Product Release Testing[edit | edit source]
Viral Clearance Studies[edit | edit source]
Biorepository Services[edit | edit source]
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[edit | edit source]
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.[edit | edit source]
Product Characterization[edit | edit source]
Physiochemical and Structural Assays[edit | edit source]
Offers a variety of assays and platforms for evaluating drug quality and customization is available.
Binding Assays[edit | edit source]
Tests the activity of Fc receptors to evaluate therapeutic antibodies
Potency and Bioassays[edit | edit source]
To ensure product quality, products are tested for reliability, stability, and consistency
Stability and Degradation Programs[edit | edit source]
Stability studies are performed on biologics to determine effects of environmental conditions.
