USP’s third-annual Peptide Week begins November 14 with a two-day synthetic therapeutic peptides workshop on regulations, standards, and quality. Can’t attend the workshop in person? Registration to attend via WebEx is available at a reduced price.
In the absence of FDA guidance documents addressing synthetic peptides, the event provides a rare public opportunity to engage FDA regulators about their current thinking regarding characterization, testing, bioassays, and more, and a chance to discuss standards setting and quality with industry thought leaders.
“As synthetic peptide manufacturing has advanced, many larger peptides that were purified from natural sources or recombinantly produced can be reproducibly and more cost-effectively produced synthetically. These molecules are in a grey area between small molecules and larger proteins in terms of the publically-available guidances for manufacturers,” says USP Global Biologics Science & Standards Director, Dr. Maura Kibbey. “This workshop has been very successful the last two years drawing the right people together to advance the field, and we expect to continue that tradition this year.”
Following the workshop, USP’s BIO 1 – Peptides Expert Committee will meet November 16-17, and workshop attendees must complete this form to request approval to attend the committee meeting as an observer. Space to attend the committee meeting in person is limited, and USP plans to offer remote WebEx attendance to approved observers.
“USP and Synthetic Therapeutic Peptides”
Dr. Anita Szajek surveys synthetic therapeutic peptides and some of the regulatory and quality questions they raise.
“New USP Standards for Characterization of Therapeutic Proteins”
Learn more about USP monographs and reference standards—official and proposed—to help manufacturers develop and analyze proteins.