Virtual Workshop from 8:30 AM – 4:15 PM ET

Date: March 30, 2023

Clusters of hypersensitivity reactions to specific lots of Immune Globulin (IG) products occur episodically and unpredictably. This phenomenon has led to voluntary market withdrawals of IG product lots and adversely affected a proportion of patient recipients. Symptoms range from urticaria, pruritis, and orofacial swelling to anaphylactic-like reactions. Resulting withdrawals of product lots and quarantining of implicated manufacturing intermediates can adversely affect IG supply. The biochemical cause of these reactions is unknown. The goals of this workshop are to:

  1. Describe clinical presentations and epidemiology of patients with hypersensitivity reactions
  2. Review pathogenesis of hypersensitivity reactions
  3. Discuss results of manufacturer’s investigations – including plasma donor factors, and manufacturing and laboratory investigations of implicated plasma units and IG lots.
  4. Seek opinions on:
    • Likely biological mechanism(s) for lot-specific clusters of hypersensitivity reactions
    • In vitro methods that could be used, or should be tried, that would identify plasma units or product lots that could cause excessive numbers of hypersensitivity reactions
    • How to minimize the number of patients affected by hypersensitivity-inducing product lots

DRAFT AGENDA FOR COMMENT/DISCUSSION

8:30 a.m.

Welcome
FDA
Immune Deficiency Foundation
Plasma Protein Therapeutics Association
8:45 a.m.

Introduction and statement of problem
Dorothy Scott, MD, Plasma Derivatives Branch Chief, FDA/CBER   
8:55 a.m. Patient experience – IVIG-associated allergic reactions
9:05 a.m.

Clinical presentation and epidemiology of hypersensitivity reactions
Meghna Alimchandani, PhD, Deputy Director Division of Epidemiology, FDA/CBER Office of Biostatistics/Epidemiology
9:40 a.m.

Pathogenesis of Type 1 hypersensitivity reactions

Introduction to Type 1 hypersensitivity reactions
Fred Finkelman, MD, McDonald Professor of Internal Medicine (Emeritus), Adjunct Professor of Pediatrics, University of Cincinnati and Cincinnati Children’s Hospital Medical Center

Role of antibodies and Fc Receptors in Type 1 Hypersensitivity
Robert Anthony, PhD, Associate Professor, Harvard Medical School

Cellular mediators of Type 1 hypersensitivity reactions
Laurent Reber, PhD, Immunology Researcher, Institute Pasteur
11:25 a.m. LUNCH
12:15 p.m.

Manufacturer Investigations of IG-mediated hypersensitivity reactions

CSL Behring
Nathan Roth, PhD, VP of Global CMC, Global Pathogen Safety, and Plasma Product Development

Grifols Biotherapeutics
Clark Zervos, MS, VP Quality
Peter Vandeberg, PhD, Director, R&D Program

Octapharma
Juergen Roemisch, PhD, Senior VP, R&D Plasma
Balazs Toth, MD, PhD, Head of Corporate Drug Safety
Josef Weinberger, PhD, Corporate Quality and Compliance Officer
2:45 p.m. BREAK
3:15 p.m.

Speaker Panel and Additional Experts
Don MacGlashan, MD, PhD, Professor of Medicine, Johns Hopkins University School of Medicine
Charlotte Cunningham-Rundles, MD, PhD, Professor of Immunology, Icahn School of Medicine, Mount Sinai

Discussion includes audience participation

4:00 p.m.

Brief summary of workshop

4:15 p.m.

Workshop Concludes