Marketplace Quality

Marketplace QualityThis project develops an approach for assessing (and improving if necessary) the quality of marketed complex drugs in three steps: 1.) Survey the available analytical techniques, 2.) Measure assay specific metrics across multiple lots and multiple manufacture, 4.) link physicochemical attributes to adverse event specific bioassays and 4.) Modernize USP monographs with improved assays and specifications.The proof of concept for developing improved tests and modernization of the USP monograph testing for complex biologic drugs was established. Many of the assays developed in this work for heparins (e.g. NMR of intact drug and MS of digested products) can be applied to other complex drug substances including protein therapeutics.

COMPLETED

ON TRACK

1. Develop protocol

10/1/2009

Completed

10/31/2009

2. Complete Phase 1: USP testing

2/28/2010

Completed

2/28/2010

3. Complete Phase 2: Determination of structural variability

9/30/2010

Completed

9/30/2010

4. Complete Phase 3: Impurity profiles and immunogenicity

12/31/2010

Completed

12/31/2010

5. Release study report and develop publications

9/30/2011

Completed

9/30/2011

6. Suggest and support any needed changes to USP monographs

9/30/2011

Completed

9/30/2011

http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardhttp://accessdata-test.fda.gov/FDATrack/track-proj?program=cder&id=CDER-OTR-Marketplace-Quality-ResourcesAdditional Articles Related to Marketplace Quality