A–Mab: A Case Study in Bioprocess Development

Downloads

30 October 2009

CMC Biotech Working Group

Version 2.1

This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.

Bioprocess

Guidance Document License Agreement

The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

If you are a retailer and are interested in purchasing our products for resale, please contact us at ask@ispe.org for more details.

View Agreement

A–Mab: A Case Study in Bioprocess Development

Downloads

Guidance Document Resources A to Z