Charles River provides the services required to conduct an expert assessment of the potential risk of biologically derived animal health products. The requirements are assessed on a case-by-case basis, but the key elements would include:
Demonstration that the source material is free from detectable adventitious agents
Demonstration that the manufacturing process is capable of removing and/or inactivating adventitious agents
Characterization of the product
Demonstration that the stability of the product and, where appropriate, the cell line
Cell Bank and Final Product Testing
Charles River offers a complete range of assays to detect adventitious agents and other contaminants. These include:
Over the past 15 years, Charles River has conducted numerous validation studies. These “spiking” studies enable quantification of the ability of a manufacturing process to remove or inactivate adventitious agents. A laboratory-scale version of our clients’ manufacturing process can be set up in our dedicated laboratories. Our experience covers many types of manufacturing processes, product types and potential contaminants including viruses, bacteria, TSEs, nucleic acids and proteins.
The identity and consistency of biologically derived animal health products are currently addressed in two ways:
For more information about our biosafety testing services, contact us at 1.877.CRIVER.1 or email@example.com.
- For products manufactured using recombinant DNA technology, the genetic stability of production cell banks is assessed by DNA sequence analysis and plasmid copy number determination
- Several batches of product must be characterized using bioanalytical techniques such as electrophoresis, isoelectric focusing, peptide mapping and mass spectrometry