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Biologics: Express Interest

U.S. Pharmacopeial Convention (USP) · usp.org
Rockville
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The job in short

Volunteer expert input on pharmacopeial standards for biologics, peptides, oligonucleotides, vaccines and cell and gene therapies.

Details

Found
40 d ago · posted 2026-04-13
Location
Rockville, MD

Full description

Therapeutic Peptides, Oligonucleotides and Complex Carbohydrates • Standards to support complex drug substances and products in the peptide, oligonucleotide, and complex carbohydrate modalities. This includes developing new and revising current general chapters, monographs, and references standards to support all three modalities. Standards to support the analysis of raw materials used in production of drug substances/products. Vaccines • Standards and guidelines to support vaccines, including mRNA, vial vectored, glycoconjugate, protein subunit, inactivated, attenuated, etc. This includes developing new and revising current general chapters and developing references standards to support vaccines. Standards for new analytical technologies. Developing standards to broadly support different vaccine modalities. Documentary and physical standards to support raw and starting material quality assessment. Therapeutic Proteins • Standards to support protein therapeutics, including Insulins, enzymes, and monoclonal antibodies. This includes developing new and revising current general chapters and developing references standards to support protein therapeutics. Standards for new analytical technologies. Developing standards to broadly support different protein therapeutic classes, for example monoclonal antibodies. Cell and Gene Therapies • Standards and guidelines to support cell and gene therapies. This includes developing new and revising current general chapters and developing references standards/materials to support cell and gene therapies. Standards for current and emerging analytical technologies in this field. Developing standards to broadly support different therapeutic classes, including in vivo end ex vivo therapies.

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