Login to MyKarger

New to MyKarger? Click here to sign up.



Login with Facebook

Forgot your password?

Authors, Editors, Reviewers

For Manuscript Submission, Check or Review Login please go to Submission Websites List.

Submission Websites List

Institutional Login
(Shibboleth or OpenAthens)

For the academic login, please select your country in the dropdown list. You will be redirected to verify your credentials.

Cover

State of the Art Analytical Methods for the Characterization of Biological Products and Assessment of Comparability

Congress, Bethesda, Md., June 2003

Editor(s): Mire-Sluis A.R. (Thousand Oaks, CA) 

Status: available   
Publication year: 2005
Buy this book
Print Version: CHF 200.00, EUR 187.00, USD 235.00
The final prices may differ from the prices shown due to specifics of VAT rules, postage and handling.
Order this title

You already have online access to this title. If you would like to buy a personal digital or print copy, please click here.


This book belongs to
Developments in Biologicals , Vol. 122
VIII + 216 p., 52 fig., 32 tab., soft cover, 2005
Status: available   
ISSN: 1424-6074
e-ISSN: 1662-2960

The latest advances in analytical technologies
With the latest advances in analytical technologies, most biological products can now be extensively characterized in terms of their identity, heterogeneity and impurity profile. The currently available analytical methods (both physicochemical and biological) can characterize the primary, secondary and to some extent, the higher order structure of proteins. The sensitivity and selectivity of these methods allow for the identification and characterization not only of the desired protein component, but also many product-related substances and impurities as well as process-related impurities present in the drug preparations. Using an appropriate selection of analytical tools, it may be possible to demonstrate physicochemical and functional comparability between protein products manufactured before and after a manufacturing change or during product development. However, the extent of demonstrable comparability depends on the tests used, on the nature of the product and on the basic understanding of structure-function relationships. Assessment of immunogenicity is also a critical component of product characterization and is highly dependent on the types of assays used.