Analytical Services for Biologics

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:

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 with links to our individual services areas.


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, click here Stability Testing.


Reference Standard Characterization
Reference Standard Characterization studies are used to determine the physicochemical profile of a drug substance or drug product in order to establish a standard for subsequent stages of testing. We offer a range of low complexity and high complexity assays for characterizing your biologic.

For more detailed information, click here Reference Standard Characterization.


Comparability and Lot Release Testing
Lot Release and Comparability testing is necessary for evaluating the purity, potency, and identity of biologics. At BioReliance, analytical assays are available for quality control testing that is regulatory compliant.

For more detailed information see our Comparability and Lot Release Testing 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.

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)
  • 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.

Contact Us: 1.800.756.5658

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