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U.S. Department of Health and Human Services

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. The complexity of biopharmaceutical drug substances and products requires the Agency to carefully consider the reliability of methods used to manufacture and characterize these drugs. Much of the data on these products and their methods of manufacture is proprietary or not easily accessible. The laboratory research highlighted in this Key Project provides essential background about the key manufacturing and product attributes that impact clinical efficacy and safety. The recently published Guidance for Industry "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product" underscores the importance of this research for the Agency to fulfill its mission to evaluate and approve biosimilar drug products under the Biologics Price Competition and innovation Act.

Accomplishment: Analytical methods such as mass spectrometry, nuclear magnetic resonance, deep-UV Raman Resonance, circular dichroism, and asymmetric field-flow fractionation with multi-angle laser light scattering were developed and evaluated for their ability to assess physicochemical attributes of biologically derived drug products (protein therapeutics, monoclonal antibodies, and complex drug substances). The results were described in seven publications that led to three invited book chapters. They have been presented to external stakeholders (industry, academia and international partners) at both national and international conferences such as the 245th American Chemical Society Annual Meeting, the 61s ASMS Conference on Mass Spectrometry and Allied Topics, and 27th International Forum on Process Analytical Chemistry and used as a basis for internal seminars and training workshops with reviewers in multiple offices at the FDA.

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

Completed 9/30/2013

4. Determine physicochemical comparability (define sameness)

9/30/2013

Completed 9/30/2013

5. Document benefits and limitations of methods and develop publications

12/31/2013

Completed 12/31/2013

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.