Final Agenda - Immune Globulin Potency in the 21st Century
Draft Agenda - Immune Globulin Potency in the 21st Century
Center for Biologics Evaluation and Research, FDA
Immune Deficiency Foundation
Plasma Proteins Therapeutic Association
National Institute of Allergy and Infectious Diseases
5601 Fishers Lane, Rockville MD 20852
November 8-9, 2017
Workshop Goals:
- To understand and predict the impact on IG products of declining measles antibodies in the plasma donor population. These include risk to PI patients who may be exposed to measles, and risk of IG shortage if multiple product lots are rejected due to failure to meet the measles potency specification.
- To evaluate the impact of polio eradication on IGIV lot release testing for polio antibodies, and discuss feasibility of BSL-2 neutralization tests using pseudotype viruses or other methods
- Discuss potential solutions to challenges in use of measles and polio titers as release tests, including consideration of replacement assays that reflect antibody activity against pathogens of current concern (such as viral infections, S. pneumoniae, H. influenza) for PI patients.
November 8, Wednesday | |
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7:00 a.m. | Registration |
8:00 a.m. | Welcoming remarks Food and Drug Administration – P. Marks, M.D., Ph.D. Introduction to the workshop (D. Scott, M.D., FDA) |
Session I. | Measles Antibody Levels in U.S. Licensed Immune Globulin Products Session Co-Chairs: Mark Ballow, M.D., University of South Florida and Dominika Misztela, Ph.D., PPTA |
8:30 a.m. |
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10:25 | Break |
10:55 | Panel Discussion |
Q1 | What is the potential impact on patients of decreasing the lot release specification for anti-measles antibodies in IG products? |
Q2 | What is the possible impact on IG supply of maintaining the current measles specification? |
Q3 | What level of measles antibody is sufficient for post-exposure protection of immune deficient patients? |
Q4 | If the measles antibody lot release specification is lowered, what other options might be feasible to provide passive protection against measles infection in immunocompromised individuals? These might include use of Intravenous Immune Globulin post-exposure, labeling of IG product lots with high anti-measles antibodies, development of specific Measles Immune Globulin preparations from high-titer donors, labeling of IG product lots for PI patients, development of a monoclonal antibody. |
11:30 | LUNCH |
Session II. | Polio Lot Release Specification for potency of IG products |
12:35 p.m. | Polio lot release specification - origins and rationale (D. Scott, M.D., FDA) (15’) |
1:00 p.m. | Polio antibody tests in the context of polio eradication
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2:30 p.m. | BREAK |
3:30 p.m. | Panel discussion (speakers) |
Q1 | What are the advantages of continuing to use polio antibody levels as a potency specification? |
Q2 | What are the drawbacks of testing in the setting of anticipated WHO biocontainment requirements? |
Q3 | Can BSL-2 assays for polio antibodies provide analogous information to that of current neutralization tests, and are such assays amenable to validation? If not, identify gaps in assay methodology that would need to be addressed. |
4:15 p.m. | Summary of Day 1 (Chairs – Session I and Session II) |
5:00 p.m. | ADJOURN |
November 9, Thursday | |
8:30 a.m. | Welcome and announcements (5’) |
Session III. | Immune globulin potency testing – the future |
8:35 | Introduction (Dorothy Scott, M.D., FDA) (10’) |
8:45 a.m. | Infections in PI patients
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10:45 a.m. | BREAK |
11:05 a.m. | Panel discussion (speakers) |
Q1 | Which antibody specificities are relevant for PI patients? Among these, please comment on test method availability and robustness. |
Q2 | Which antibody specificities are likely to be highly consistent across products? |
Q3 | Which tests for relevant antibodies may warrant further study in IG products? |
11:40 a.m. | Summary of Day 2 (Session Chairs) |
12:00 | ADJOURN |