Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development: Rockville, Md., September 1999(106 Developments in Biologicals)

In September 1999, the cell substrate workshop entitled "Evolution of Cell Substrates Used in the Manufacture of Biologicals" was held as a means to consider in depth the issues raised by the need to use neoplastic, ie continuous, cells as substrates for viral vaccine manufacture. Workshop goals included identifying the risks andconcerns associated with the use of neoplastic cell substrates and determining the manner in which these could be assessed. Volume 106 of "Developments in Biologicals" presents the edited proceedings of this workshop. It is the latest in a series of monographs that go back to 1967 and record the proceedings of meetings devoted to issues concerning the use of cells cultured in vitro as substrates for the manufacture of viral vaccines. The current workshop covered the following: a review of the history of cell substrate use in the production of biologicals; scientific issues related to the development of the neoplastic state and tumorigenicity; viral-viral and viral-cell interactions; the oncogenic potential of residual cell-substrate DNA; adventitious agent testing; and ways to generate immortalized cells in vitro. The purpose of these discussions was to build on the concepts and precedents for the scientifically based, regulatory management of viral vaccines documented in the earlier monographs. It is the hope of the meeting organizers and sponsors that this volume will assist in generating confidence among vaccine developers, manufacturers, regulatory agencies and the general public that the use of neoplastic cell substrates, within an effective, reasoned, regulatory approach, is feasible.

Table of Contents:
Session I - Evolution of Cell Substrates Used in the Manufacture of Biologicals; Session II - Mechanisms of Neoplastic Development and Neoplastic Cell Tumorigenicity - Implications for Cell Substrate Development; Panel-Audience Discussion I - Mechanisms of Neoplastic Development and Neoplastic Cell Tumorigenicity - Implications for Cell Substrate Development; Session III (Part 1) - Viral-Viral and Viral-Cellular Interactions; Session III (Part 2) - Viral-Viral and Viral-Cellular Interactions; Panel-Audience Discussion II - Viral-Viral and Viral-Cellular Interactions; Session IV - Cellular DNA as a Potential Source of Oncogenic Activity or Infectious Agents; Panel-Audience Discussion III - Cellular DNA as a Potential Source of Oncogenic Activity or Infectious Agents; Session V - Miscellaneous Topics; Session VI - Adventitious Viral Agents in Cell Substrates; Panel-Audience Discussion IV - Adventitious Viral Agents in Cell Substrates; Session VII - Designer Cell Substrates; Panel-Audience Discussion V - Designer Cell Substrates and Meeting Summary. Appendix: A Defined-Risks Approach to the Regulatory Assessment of the Use of Neoplastic Cells as Substrates for Viral Vaccine Manufacture.