Rebecca Sheets Libri

Focusing on the international regulatory landscape for biologicals, this book offers a comprehensive introduction to vaccine and biotechnology medicine regulations. It presents key scientific concepts and regulatory challenges while providing practical insights into the regulatory processes across different regions. Enhanced with case studies and real-world examples, it serves as a valuable resource for graduate students, educators, regulatory officials, and industry scientists involved in the development of biotechnological products.

This publication comprises the proceedings of the Vaccine Cell Substrates 2004 conference. The purpose of this conference was to review current data and progress in the field of cell substrates, discuss the continued use of existing tests and the appropriateness of new ones at this time, and develop consensus recommendations on how to address these issues, by either recommending implementation or identifying research gaps that preclude decision-making. Scientific topics covered oncogenicity of cellular components, both latent viruses and cellular DNA, viral adventitious agent test methods, level of assurance provided by the current tests, bovine (and porcine) viruses in (primarily) bovine-derived raw materials, and bovine spongiform encephalopathy agents as potential contaminants of cell substrates. Also presented were tests that ensure the safety and quality of novel vaccine cell substrates for investigational vaccine production. Academia, regulators, the vaccine industry and the testing industry developing, regulating or testing viral vaccines will greatly benefit from the wealth of new findings.