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Varicella Zoster Immune Globulin (VZIG)

Varicella Zoster Immune Globulin (VZIG). Donna M. Ambrosino, M.D. Director and Professor Massachusetts Biologic Laboratories University of Massachusetts Medical School Catherine A. Hay, Ph.D. Senior Director of Regulatory Affairs Massachusetts Biologic Laboratories

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Varicella Zoster Immune Globulin (VZIG)

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  1. Varicella Zoster Immune Globulin (VZIG) Donna M. Ambrosino, M.D. Director and Professor Massachusetts Biologic Laboratories University of Massachusetts Medical School Catherine A. Hay, Ph.D. Senior Director of Regulatory Affairs Massachusetts Biologic Laboratories University of Massachusetts Medical School

  2. Overview • Plasma Screening Assay • Manufacturing Process • Potency Assay • Supply Issues (Dr. Ambrosino)

  3. Plasma Screening • Units screened by Complement Fixation Assay (positive at 1:50 dilution) • Both pheresis and recovered plasma used

  4. Complement Fixation Assay • In-house assay • “A Guide to the Performance of the Standard Diagnostic Complement Fixation Method and Adaptation to Micro Test.” US DHHS, PHS, CDC, February 1981

  5. VZV Antibody Screening

  6. Manufacturing Process • Cold ethanol precipitation (Cohn-Oncley) • Solvent/detergent viral inactivation step • Final liquid formulation • 10-18% IgG • pH 6.4-7.2 • 0.3 M Glycine

  7. Plasma Pool Fraction I Supernatant Fraction II + III Paste Fraction III Supernatant UF – Concentration & Diafiltration Filter Aid Addition/Filtration Solvent/Detergent Viral inactivation (0.3% TNBP/1% Triton-X 100) UF - Concentration Formulation Sterile Filtration

  8. Potency Assay (since 1984) • Virgo Immunofluorescence Assay • Kit manufactured by Hemagen • slide test: antibody-antigen complex formed; fluorescein-labelled anti-human antibody added; apple-green fluoresence in presence of antibody-antigen complex • Positive and negative controls from kit • In-house standard (qualified for use by comparison to previous standard) • 2-fold dilutions (1:1024 – 1: 32768) • Endpoint is highest dilution showing positive reaction

  9. Potency Assay Acceptance criteria: • In-house standard titer: 8192 (allowed range: 4096 – 16384) • Final vial specification: potency ratio:  0.8 x in-house standard

  10. Potency Data

  11. Massachusetts Biologic LaboratoriesUniversity of Massachusetts Medical School • ONLY non-profit FDA-licensed vaccine and biologic manufacturer in the US. • Td vaccine for US • Develop new monoclonal antibodies • Blood Products

  12. Massachusetts Biologic Laboratories1894 - 2005 1894 2005 2007

  13. Td Shortage“The Pink Sheet” February 26, 2001 “CDC is looking to MBL to ease the tight tetanus supply this year. MBL makes a small amount of Td. We are hopeful that they will boost production.” Dean Mason (CDC Program Support Branch Chief)

  14. Entering the New Field of Monoclonal Antibody (MAB) Development • Orphan Products (a.k.a. too small for big pharmaceutical companies) • Urgent public health need

  15. MBL Blood Products • Albumin [Human] • RespiGam® (Respiratory Syncytial Virus Immune Globulin Intravenous [Human]) • VIG (Vaccinia Immune Globulin Intravenous [Human]) • CytoGam® (Cytomegalovirus Immune Globulin Intravenous [Human]) • BabyBIG (Botulism Immune Globulin Intravenous [Human]) • VZIG(Varicella Zoster Immune Globulin [Human]) • ISG (Immune Globulin [Human] for IM Use Only)

  16. Supply: Annual VZIG Vials* Sent to Distributor or Actual Sales (in blue)(1978-2005) vaccine licensed *Each 625 unit vial is counted as 5 vials. NOTES: 1978-1980 = IND Status 1996-1997: Non-S/D VZIG withdrawn in 4Q96; replaced in 1997 with SD VZIG. Distribution averaged for 1996 & 1997 Red Cross uses a national distributor

  17. Current Supply • We estimate that supply will last until January 2006 (although may be a few months longer) • No pediatric dose vials available

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