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U.S. Department of Health and Human Services

About FDA

Marketplace Quality

Description: This 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.

Accomplishment: 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.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

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

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.