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  1. Workshops, Meetings & Conferences (Biologics)

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:

  1. 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.
  2. 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
  3. 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

7:00 a.m.Registration
8:00 a.m.

Welcoming remarks

Food and Drug Administration – P. Marks, M.D., Ph.D.
Immune Deficiency Foundation – J. G. Boyle, MA
Plasma Protein Therapeutics Association – M. Gustafson, MS
National Institute of Allergy and Infectious Diseases – S. Ferguson, 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.
  1. Summary of measles lot release testing history, rationale, and the current release specification (D. Scott, M.D., FDA) (15’)
  2. Measles epidemiology – to include overall risk of measles in the US and globally, reported infections in PI patients, and impact of herd immunity on risk to PI patients (Manisha Patel, M.D., CDC) (20’)
  3. Measles pre-exposure and post-exposure prophylaxis with Immune Globulin Products (Mark Papania, M.D., MPH, CDC (20’)
  4. Measles antibodies in donor plasma: longitudinal data and forecast
    (Toby Simon, M.D., CSL Behring) (20’)
  5. Measles antibody trough levels after IG treatment; theoretical values assuming lower measles antibody specifications (Peter Vandeberg, Ph.D., Grifols) (20’)
  6. Use of MMR vaccine to increase
10:55Panel Discussion
Q1What is the potential impact on patients of decreasing the lot release specification for anti-measles antibodies in IG products?
Q2What is the possible impact on IG supply of maintaining the current measles specification?
Q3What level of measles antibody is sufficient for post-exposure protection of immune deficient patients?
Q4If 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.
Session II.

Polio Lot Release Specification for potency of IG products
Session Co-Chairs: Robin Levis, Ph.D., FDA and Thomas R. Kreil, Ph.D., PPTA)

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

  1. Progress of polio eradication efforts and containment requirements post-eradication (Steve Oberste, Ph.D., CDC) (25’)
  2. Polio disease, passive immune therapy for prevention or treatment of polio, and incidence of polio infection in primary immune deficient patients (Manisha Patel, M.D., CDC) (25’)
  3. Poliovirus excretion and incidence of polio in Primary Immune Deficient patients (Mark McKinlay, Ph.D., Task Force for Global Health) (25’)
  4. Development of hyperattenuated poliovirus strains and validation of their use in antibody assays under reduced containment (Andrew Macadam, Ph.D., NIBSC) (25’)
2:30 p.m.BREAK
3:30 p.m.Panel discussion (speakers)
Q1What are the advantages of continuing to use polio antibody levels as a potency specification?
Q2What are the drawbacks of testing in the setting of anticipated WHO biocontainment requirements?
Q3Can 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
Session Co-Chairs: John G. Boyle, MA, IDF, and Dorothy Scott, M.D., FDA

8:35Introduction (Dorothy Scott, M.D., FDA) (10’)
8:45 a.m.

Infections in PI patients

  1. Epidemiology of infections in Primary Immune Deficiency patients (Paul Maglione, M.D., Mount Sinai NY) (25’)
    Potential Candidate Potency Specificities and Tests
  2. Antiviral antibody levels across IG products (Thomas R. Kreil, Ph.D., Shire) (20’)
  3. Vaccine-induced antibodies in IG products (Mel Berger, M.D., Ph.D., CSL Behring) (20’)
  4. Pneumococcal infections, pneumococcal immunity assessment, and recommendations for IG product evaluation (Ricardo Sorensen, M.D., LA State University) (20’)
  5. Questioning the accuracy of currently available pneumococcal antibody testing (William Shearer, M.D., Ph.D., Texas Children’s Hospital, and Joud Hajjar, M.D., MS, Baylor College of Medicine) (15’)
  6. Opsonophagocytosis and other methods to detect functional antibodies against encapsulated bacteria (Moon Nahm, M.D., University of Alabama) (20’)
10:45 a.m.BREAK
11:05 a.m.Panel discussion (speakers)
Q1Which antibody specificities are relevant for PI patients? Among these, please comment on test method availability and robustness.
Q2Which antibody specificities are likely to be highly consistent across products?
Q3Which tests for relevant antibodies may warrant further study in IG products?
11:40 a.m.Summary of Day 2 (Session Chairs)


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