FDA Grand Rounds: Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins
October 13, 2022
The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.
The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. Within the Center for Drug Evaluation and Research (CDER), the Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources have been developed to improve the FDA's understanding of the approach.
- Multi-Attribute Method for Quality Control of Therapeutic Proteins. Sarah Rogstad, Haoheng Yan, Xiaoshi Wang, David Powers, Kurt Brorson, Bazarragchaa Damdinsuren, and Sau Lee. Analytical Chemistry 2019 91 (22), 14170-14177. DOI: 10.1021/acs.analchem.9b03808
- Discuss the research conducted at the FDA
- Explain how FDA science impacts public health
- Discuss how the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins.
- Discuss how the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run.
- Discuss the key considerations for implementation of the multi-attribute method, including risk assessment, method validation, new peak detection, and conventional method comparisons.
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency external scientific communities.
Lecture 1 October 13, 2022
|12:00 - 1:00 PM EDT||Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins||
Sarah Rogstad, PhD
Frances Namuswe, PhD
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
- Namuswe, Frances, PhD, Lead Chemist, Office of Biotechnology Products, OPQ, CDER - nothing to disclose
- Rogstad, Sarah, PhD, Senior Scientific Advisor, US FDA - nothing to disclose
- Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
- Pfundt, Tiffany, PharmD, Senior Advisor, HHS/ASPR - nothing to disclose
- Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose
CE Consultation and Accreditation Team
- Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary, therefore refunds are not applicable.
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