Course Description:
As more peptide and oligonucleotide-based drugs enter the marketplace (6 approved in the US in 2020 alone), standards that support their quality are critical. In 2020 when the new USP Expert Committees reformed, the BIO1 Expert Committee (EC) was commissioned to continue its commitment to peptide standards and to expand its workplan to also support oligonucleotide products. Since 2020 the new BIO1 EC has released 9 new peptide reference standards, revised 3 new monographs and developed a new general chapter <1504> which provides an overview of the minimum quality attributes for starting materials used in the manufacture of synthetic therapeutic peptides. The EC has also been active supporting the revision of peptide monographs that were previously recombinant to synthetic. This presentation will detail this work and describe needs from peptide manufacturers for future work.
Related to oligonucleotides, the EC is first focusing on the quality of phosphoramidite raw materials. Due to the repetitive nature of oligonucleotide synthesis, the risk of phosphoramidite impurities impacting final oligonucleotide quality is high and currently no standards exist. USP in collaboration with oligonucleotide
experts have identified common DNA and RNA raw material phosphoramidites for standard development. Potential bulk materials for future reference standards are initially being evaluated for identity and purity. Molecular weight will be determined by mass spectrometry, chemical signature by 31P NMR, and impurity levels by HPLC. This talk will share the progress on this project and future oligonucleotide plans.
Who should participate:
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
- Student
The live version of this recording took place on during the USP Workshop on Therapeutic Peptides and Oligonucleotides:
Regulations and Quality Standards on February 28, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Sarita Acharya
Principal Scientist, Science-Global Biologics, U.S. Pharmacopeia
Julie Zhang
Team Lead, Senior Scientist II, Science-Global Biologics, U.S. Pharmacopeia