About FDA
Characterization of Biologically Derived Drug Products
Description: This project will develop and evaluate analytical methods to assess physicochemical attributes of biologically derived drug products that affect function.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Identify methods that characterize molecular structure (primary, secondary, tertiary), post translational modification and stability (aggregation/degradation) |
6/30/2011 |
Completed | 6/30/2011 |
|
2. Select model systems representing drug classes to assess suitability of methods |
12/31/2011 |
Completed | 12/31/2011 |
|
3. Establish analytical method capabilities to measure potential critical product quality attributes |
9/30/2013 |
On Track | |
|
4. Determine physicochemical comparability (define sameness) |
9/30/2013 |
On Track | |
|
5. Document benefits and limitations of methods and develop publications |
12/31/2013 |
On Track |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
