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Assays and Services

BioReliance offers the following services and assays for Analytical Services:

Analytical Chemistry Services
A range of selective and sensitive analytical methods is used to test pharmaceuticals to show their levels of purity, identity, potency, stability and/or comparability. These tests are used to demonstrate that the product's molecular structure meets predefined criteria and that the products are manufactured consistently and remain stable and efficacious in the final product formulation. Analytical methods are essential for the analysis and characterization of biotechnology or biological products (biologics) as well as the characterization of classical pharmaceutical products (chemical entities).

Our Analytical Chemistry Services include Stability Testing and Protein Characterization assays, incorporating a full range of appropriate analytical methods.

Stability Testing
Stability testing is used to demonstrate short and long term stability of a drug substance/product after exposure to a variety of environmental factors including temperature, humidity and light.  BioReliance staff has the experience and expertise necessary to apply methods that will detect changes in the identity, purity and potency of the product.

At BioReliance we offer stability storage capabilities operated under ICH recommended conditions with continuous maintenance, monitoring and security. BioReliance stability protocols are designed to meet the requirements outlined in the ICH guidelines.

Protein Characterization Assays
There are a variety of different analytical methods which can be used to analyze chemical entities and biologics, with the exact methods required depending on the type of product being developed, the clinical application and the stage of clinical trials for which the product is intended.   For a typical biologic (protein), tests used can include the following:

For identity:

  • Amino Acid Analysis
  • Protein Sequencing
  • Peptide Mapping
  • Monosaccharide Analysis
  • Oligosaccharide Mapping
  • Molecular Weight Analysis
  • N-terminal sequencing with LC/MS/MS
  • Extinction Coefficient Determination

For purity:

  • SDS-PAGE Analysis
  • RP-HPLC
  • SEC-HPLC (Aggregation)
  • IEX-HPLC
  • Western Blot Analysis
  • Host Cell DNA
  • Absence of Microbial/Viral Contaminants
  • LAL Test
  • Immunodiffusion
  • Colorimetric Assays

For Potency:

  • Biological Activity Assay
  • In vivo assay
  • In vitro assay

Immunoassays and Cell Based Assays

BioReliance’s bioanalytical group offers comprehensive services in analysis of test samples for stability and potency using a variety of biological and immunoassay methods.

 

Immunoassays
BioReliance offers a wide range of Immunoassay services in both the US and UK.  Our assay services focus on custom assays developed to meet client-specific needs and timelines. BioReliance offers chromogenic, fluorescent and luminescent assay platforms, as well as multiplex analysis using the Meso Scale Discovery® electrochemiluminesence detection platform.

 

We offer the following Immunoassay services:

Quantitation of host cell protein and bioprocess contaminants
These assays are used to identify and quantitate the presence of contaminants including Protein A, bovine serum albumin, human serum albumin and proteins from host cells such as E. coli, Chinese hamster ovary and SP2/O in final products and in-process samples.

Transfer and optimization of existing assays to our laboratory
BioReliance can transfer your assays into our laboratories and perform them under GLP guidelines or develop assays de novo.  In addition, our scientists can optimize these assays to increase sensitivity, robustness and widen limits of detection.

Validation of assays to regulatory guidelines
All immunoassays performed at BioReliance can be validated to required global regulatory guidelines.

Clinical Trials Laboratory Support
Our immunoassay laboratories can perform sample analysis for clinical trial samples, including PK, cytokine and immunogenicity analysis.

Within the Immunoassay group BioReliance also provides additional services, including cell-based bioassays.  These assays are used to measure the biological response of test material.  These assays are customized to client-specific requirements and include:

  • Plaque assays:  these assays are used to demonstrate the presence or absence of viral contaminants in final products and process samples.
  • Neutralization assays:  in these assays antibodies are used to inhibit the biological activity of viruses or toxins using a cell viability or plaque reduction as the endpoint.
  • Potency and stability assays: 
    The biological activity of a test article is measured in the appropriate cell based system and compared to reference standards.  This method is often used to verify that a product retains biological activity and that the biological activity can be correlated to the product’s analytical profile.