IDM Validation Project RemoteProject Summary Provides high-quality cellular source material from the Registry for further manufacturing into cell and gene therapies. Through this process, BioTherapies coordinates the testing of donor samples for infectious disease markers (IDMs) to determine eligibility for use in patients. Pursuing a validation study to demonstrate suitability of donor samples that are processed outside of current procedures outlined in IDM kit instructions for use, including impact on detection across a range of titers. These tests include both PCR and serological-based tests. These deviations for testing include:
- Delay of centrifugation post-draw out to 7 days.
- Lack of maintenance of samples at 2-8C up to 7 days.
These studies will be utilized to support material that is used to manufacture therapies for treatment of patients in the EU. In support of these studies, seeking a consultant to assist in drafting an appropriate study plan and parameters that will be executed by a contracted third party laboratory. This work could include data analysis and interpretation of study results. The ideal candidate will have knowledge of clinical microbiology, IDM testing, IDM test validations, and the EU regulatory landscape regarding IDM testing for cell therapy products. #DICE ...@c4techservices.com