As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?
Recently, Bioanalysis Zone announced that nominations are now being accepted for the New Investigator’s award (formerly the Young Investigators award) which is sponsored by Waters Corporation for the 5th year in a row. This is… Read more >
Webinar Highlights | Simplifying Methods Transfer: Novel Tools for Replicating Your Established Methods on an ACQUITY Arc System I’m Dr. Paula Hong, Principal Scientist at Waters Corporation. I recently conducted a webinar that talked about the… Read more >
In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39… Read more >
Webinar: QbD Development of a Purity Method Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The… Read more >