cancer gene analysis
Medicines and Healthcare products Regulatory Agency · United Kingdom
Key facts
- Engagement closes
- 25 May 2018
- Buyer type
- Central government
Description
The UKSCB requires an external contractor (third party) to perform cancer gene analysis on UKSCB derived EU Tissue and Cellular Directive (EUTCD) compliant human embryonic stem cell (hESC) lines. UKSCB is licenced under the HTA Human Tissue (Quality and Safety for Human Application) Regulations 2018 for the production of starting materials for clinical application. According to HTA regulations any testing activities that are subcontracted to external contractors must be appropriately validated to demonstrate that the testing method is fit for purpose. In addition, the contract testing laboratory has to be accredited by the regulatory body for the licensable activities. It is estimated that the contact will run for at least of three years and will cover testing of approximately 38 hESC lines. The contact should be priced based on the number of cancer genes in the panel and DNA isolation from cell lines. Further communications or meetings can be arranged for additional details on the testing or validation. As part of ongoing UKSCB service provider qualification program the third party might require to fill UKSCB Quality Questionnaire or accommodate on-site audit by UKSCB.
For further information and if you believe, you have the capability to do this work, please feel free to contact via email ([email protected]) before close of play 25 May 2018.
Categories (CPV)
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