Development of Vaccines

Manmohan Singh

• 28 juli 2011
• 9780470256374

Samenvatting:

Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial.

Leading experts guide you step by step to a successful clinical vaccine trial

Development of Vaccines sets forth the issues and the challenges of vaccine development and the solutions needed to seamlessly advance a biologic drug formulation from discovery through all the essential steps that lead to a successful clinical vaccine trial. The authors skillfully guide you through everything you need to know, including current analytical tools and techniques, vaccine expression, purification, formulation, and preclinical testing. Not only does the book guide you through lab work, it also explains the regulatory submissions process, helping you gather and report the necessary data.

Divided into five sections, this book serves as a reference to all the critical steps that take place from discovery to clinical trials:

• Details all the tools needed for immunogen design and development

• Investigates vaccine platforms, including virus-like particles, nanocapsules, DNA vaccines, and protein expression and purification

• Explains the spectroscopy and biophysics techniques needed for accurate immunogen characterization

• Demonstrates how to optimize formulations and evaluate stability

• Details all the steps needed to file a new application for clinical vaccine testing

Each chapter of the book has been authored by one or more leading authorities with expertise spanning the critical areas of vaccine expression, purification, formulation, preclinical testing, and regulatory submission. Their contributions are not only based on a thorough review of the literature, but also their own hands-on lab bench experience, making this an unsurpassed guide to all stages of vaccine development.

Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.