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Looking for laboratory to outsource ELISpot and ELISA assays for phase I clinical trial

  • Pre-clinical development and testing, pre-clinical CRO, Clinical development and testing, clinical CRO, Analytical laboratory and testing services
  • Human Medicines
  • Worldwide
  • 10/31/2012

Description

We are looking for laboratory to outsource ELISpot and ELISA assays for our phase I clinical trial. We will testing our autologous cancer vaccine in lymphoma patients. We would like to determine immunological parameters such as ELISpot (for gamma IFN) and ELISA (for 2 different antigens). We expect 60 PBMC samples and 60 plasma samples.

I would like to know the followings:

1. How much PBMCs would be required from each patient sample for ELISpot (gamma-IFN)
2. Since our immunogen will be inactivated patients’ (Autologous) tumor cells, how many cells will be required for testing?
3. Since each patient sample is different, how would ELISpot assay will be optimized or validated?
4. Have you done ELISpot with whole cell as immunogen?
5. We also like to know whether you could provide ELISA service (for two different immunogens) for 60 plasma samples?
6. We are thinking of outsourcing both ELISpot and ELISA services to third party in our Phase I clinical trial. Therefore, are you geared towards providing data to FDA standards? In other words, have you participated in FDA approved clinical trials?

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