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Analytical Services

Welcome to the homepage for Analytical Services. Manufacturers of biologics, such as blood products, monoclonal antibodies, recombinant proteins, tissue derived products, and some medical devices are required to assess the quality and purity to ensure products are safe for use in humans.

 

BioReliance offers the following Analytical Services:

  • Stability Testing
  • Contaminant Analysis (Protein Characterization)
  • Method Transfer Validation
  • Neutralization Assays
  • Immunoassays (various)

 

BioReliance has conducted numerous Analytical Studies for clients around the globe.  Our experience allows us to advise our clients on the most appropriate process steps to study in order to satisfy regulators.

 

Below you will find some detailed information about our Analytical Services to help you learn more as well as links to individual services.

 

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.  The BioReliance staff has the experience and expertise necessary to apply methods that will detect changes in the identity, purity and potency of biologics.

 

For more detailed information see our stability testing page.

 

Contaminant Analysis

Contaminant Analysis is useful to identify potentially harmful agents present in biologics including microbial contaminants, host proteins, cell culture pyrogens, and raw materials from downstream processing.  We offer a number of analytical techniques for detecting contaminants such as ELISAs, HPLC, and potency assays.

 

For more detailed information see our contaminant analysis page.

 

Method Transfer Validation

Method Transfer Validation is used to confirm that the analytical procedure employed for a specific test is suitable for its intended use and is required for complete compliance with cGMP and GLP regulations, US FDA and international regulatory guidelines.  This is especially critical when assays and methods are transferred to new facilities for scale up or raw materials manufacturing.

For more detailed information see our method transfer validation page.

 

Neutralization Assays

Neutralization Assays assess the ability of antibodies within a tested sample to protect cells in culture from toxins or viruses for example. This analytical method can distinguish between reversible and stable neutralization.

 

For more detailed information see our neutralization assay page. 

 

In addition, BioReliance also can develop customized analytical methods for analysis of a wide range of active compounds. Services can be provided to meet GLP or cGMP guidelines.

 

Methods for analytical services include:

  • High performance liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Gas chromatography/mass spectrometry (GC/MS)
  • Liquid chromatography/mass spectrometry (LC/MS/MS)
  • Capillary electrophoresis (CE)
  • Additional assays available

 

BioReliance adheres to all regulatory guidelines and each step of testing (receipt, storage, distribution, and testing) is controlled by our experienced research team.