We are interested in conducting in process testing for residual enzymes to check our process efficiency at a couple stages. Can you explain what kind of information we will gain by running your kits particularly with respect to in process tests? Also do you have any recommendations for using you kits in this manner?
This question is part of the following Ask The Expert session:
Verifying Removal of Residual Production Enzymes from Your Final Product
Company: Roche Custom Biotech
Job Title: Industrial Consultant
These ELISA kits are intended for quantitative detection of the respective enzyme proteins in manufacturing processes of biopharmaceutical and cell therapy products. They can be used with sample material from aqueous buffer solutions from biotechnological processes, as well as cell culture supernatant. The wide measuring ranges for each assay make them suitable for different matrices and a broad range of sample types from both in-process samples to bulk drug substances. Thus, they can be used at different stages of your product development process.
The kits include the necessary standards and controls. Instructions for Use for these kits provide an example of typical results for a calibration curve. The appropriate calibration values need to be generated for each run, with the standards placed on the same plate as the samples within a run. With the calibration curve you generate you will be able to derive a quantitative result for your samples. Individual results may vary depending on the sample matrix and the test run.
In conclusion, the kits can help to determine the efficiency of your purification techniques at multiple stages of the development process. This information can help you make adjustments to existing procedures and optimize your overall time to release.