Skip to main content

Process Chromatography

A Guide to Validation

  • 1st Edition - September 2, 2015
  • Authors: Gail K. Sofer, L. E.E. Nystrom
  • Language: English
  • eBook ISBN:
    9 7 8 - 1 - 4 8 3 2 - 8 9 1 7 - 5

Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed… Read more

Process Chromatography

Purchase options

LIMITED OFFER

Save 50% on book bundles

Immediately download your ebook while waiting for your print delivery. No promo code needed.

Image of books

Institutional subscription on ScienceDirect

Request a sales quote
Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.