Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals

Více o knize

This publication provides an up-to-the-minute account of current practices and policies concerning the use of animal-derived products in the manufacture of biopharmaceuticals.For the first time, different views and concerns of pharmaceutical industries, academic experts, suppliers of serum and other animal products, and the relevant regulatory agencies are described in one single volume. It mainly focuses on current perceptions of the risks posed by contamination of biopharmaceuticals with viruses or other infectious agents from animals and how these risks can be managed.This book, succeeds in clarifying many of the technical and regulatory questions, surrounding the use of animal products. Professionals concerned with sourcing raw materials, process development, quality assurance and control and regulatory affairs will find it a valuable reference and a great help in dealing with the special challenges posed by these materials.