FDA Determination of Qualification Limits Peptide-related Impurities of - Products to Inform Guidance

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

10/23/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at White Oak, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines.

This project will concentrate on establishing Immunogenicity-Based Qualification Thresholds for Peptide and Protein Impurities as well as assessing HLA-Restricted T-Cell and Anti-Drug Antibody Risk. Per regulation, follow-on peptide and protein therapeutics approved under the 505(j) and 505(b)(2) pathways may not require new clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process/product-related impurities) may alter immunogenicity risk and affect safety, pharmacokinetics, pharmacodynamics, and efficacy.

Current FDA guidance (e.g., the 2021 guidance for certain highly purified synthetic drug products referencing rDNA origin drugs) provides analytical qualification limits for impurities but does not establish thresholds based on immunogenicity risk. This creates regulatory uncertainty for industry applicants and reviewers. The proposed project addresses this gap by experimentally defining impurity qualification thresholds that incorporate immunogenicity risk and mechanistic understanding of HLA-restricted T-cell activation.

• Establish advanced analytical methods to detect and quantify peptide and protein impurities that may contribute to immunogenicity risk of a product;
• Conduct stressed and accelerated stability studies to generate peptide and protein drug-related impurities for in vivo, in vitro analytical/immunogenicity assays;
• Establish and optimize MHC-associated peptide proteomics (MAPPs) methods to elucidate HLA-restricted mechanisms of Drug-specific T-cell responses;
• Gain experience in immunogenicity and advanced analytics and collaborate in a multi-disciplinary research team.

The mentor for this opportunity is Uriel Ortega-Rodriguez (Uriel.Ortega-Rodriguez.gov). If you have questions about the nature of the research, please contact the mentor.

Start date is flexible and will depend on a variety of factors.

The appointment will initially be for two years, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

The appointment is full time.

The participant will receive a monthly stipend commensurate with educational level and experience.

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

This program, administered by ORAU through its contract with the U.S.…