FDA Fellowship - Immunogenicity of Protein Therapeutics

Research Project

Under the guidance of a mentor, you will receive training in cutting‑edge technologies directly relevant to promoting public health. The specific research project involves optimizing Intravenous Immunoglobulin (IVIG) for the treatment of neurological diseases. You will investigate whether enzymatic enrichment of the sialylated IVIG fraction from 10–20% to 80% can produce a more potent, lower‑dose product, potentially enabling a four‑fold dose reduction.

The project involves developing and validating analytical methods to achieve and quantify Fc sialylation across multiple licensed IVIG products, characterizing how sialylated IVIG engages the immune receptors Fc RIIB and DC‑SIGN in vitro, developing a standardized cell‑based assay for IVIG anti‑inflammatory potency assessment, and testing whether hypersialylated IVIG suppresses neuro‑inflammation at lower doses in Fc R‑humanized mouse models of neurological autoimmunity.

• Develop proficiency in orthogonal analytical methods—lectin‑based assays (SNA, ECL), lectin affinity chromatography, and LC‑MS/MS glycan profiling—to enzymatically sialylate and rigorously characterize the Fc glycan profiles of commercial IVIG products across multiple manufacturers.
• Gain expertise in the mechanistic basis of IVIG anti‑inflammatory activity, including hands‑on experience with Fc R binding and signaling assays using reporter cell lines, surface plasmon resonance (SPR), flow cytometry, and HEK 293‑T co‑expression systems to characterize Fc RIIB and DC‑SIGN co‑engagement.
• Learn to design, develop, and qualify a cell‑based potency assay, translating mechanistic biological insights into regulatory‑grade analytical tools applicable to biologic product evaluation.
• Acquire skills in conducting and interpreting animal studies in vivo.
• Develop an understanding of the application of NAMs in biologic development and regulatory science within FDA biologics evaluation.

Dr. Basil Golding (basil.golding.gov). Contact him for information about the nature of the research.

• Anticipated Appointment
  
  Start Date:
  
  August 1 2026 (flexible based on various factors)
• Appointment Length:
  Initially one year, may be renewed upon recommendation and contingent on funding availability
• Level of Participation:
  Full time
• Participant Stipend:
  Monthly stipend commensurate with educational level and experience

• Citizenship: U.S. citizen or Legal Permanent Resident
• Degree:
  Master’s or Doctoral degree received within the last 60 months or anticipated to be received by June 30 2026
• Discipline(s):
  • Life Health and Medical Sciences – including Agricultural Sciences, Agriculture, Agronomy and Crop Science, Anatomy, Animal Behavior, Animal Health and Food Safety, Animal Sciences, Basic Biomedical Sciences, Biochemistry, Bioinformatics, Biology (General), Biophysics, Botany, Cellular and Molecular Biology, Comparative Medicine and Laboratory Animal Medicine, Computational Biology, Developmental Biology, Ecology, Ecosystem Ecology, Emergency and Incident Management, Entomology, Environmental Health, Epidemiology, Evolutionary Biology, Food Sciences and Technology, Genetics including Genome Sciences, Health Physics, Horticulture, Immunology, Industrial Hygiene, Infectious Diseases and Zoonoses, Kinesiology and Exercise Physiology, Medicine, Microbiology, Neurosciences, Nursing, Nutritional Sciences, Occupational Health, Pharmacology, Pharmacy, Physiology, Plant Sciences, Population and Community Ecology, Population Medicine, Public Health, Structural Biology, Toxicology, Veterinary Sciences, Virology, Wildlife Sciences, Zoology (General)

The qualified candidate should have received or be currently pursuing a master’s or doctoral degree in one of the relevant fields (Biology, Pharmaceutical Science, Chemistry, Biochemistry, Immunology). The degree must have been received in the past five years or be completed by June 30 2026.

I am a U.S. citizen, or I have lived in the United States for at least 36 of the past 60 months (not required to be consecutive). I have read the FDA Ethics Requirements.