CVC EPP annoucement

The Cancer Vaccine Consortium is organizing a groundbreaking project that could help member organizations achieve their product development goals. First presented at the CVC's 4th Semi-Annual Meeting in San Francisco, this project could both resolve basic assay problems and establish cooperation with other groups. The session for the Manufacturing Working Group in San Francisco included a presentation by Cort Wrotnowski (Amvir Associates) on a proposal for members to join together in carrying out an ELISPOT proficiency panel.

This project can save considerable time and cost for establishing validation standards for an ELISPOT assay for interferon-gamma. The proposal is to conduct a proficiency panel based on recently completed work by the ELISPOT Collaborative Study Group, a network of 11 labs involved in HIV vaccine trials.

This panel would enable assay comparability to become established on a much broader basis. Moreover, since this panel draws on prior work conducted in the HIV vaccine field, CVC member companies will be linking to a larger community of assay development. Participation in this panel could set the stage for achieving validation of more complex cellular phenomena in subsequent panels. This work connects with ongoing efforts in different parts of the NIH, as well as other groups that work with the FDA.

The benefits to participants in the ELISPOT proficiency panel project are considerable. They include:
1. Establishing leadership in shaping assay standards
2. Initiating the process of working with the FDA on common assay standards
3. Reducing time and cost of assay development
4. Preserving current SOPs while providing a basis for improving individual protocols. 5. Building connections to other research groups
6. Providing support for broader assay development efforts

For further information about the ELISPOT proficiency panel, including opportunities to participate, please email Susan Geiger, Executive Director of the CVC, susan.geiger@sabin.org or call (414) 918-3199.

Caution!