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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

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

overview
Overview
  • Plasma Screening Assay
  • Manufacturing Process
  • Potency Assay
  • Supply Issues (Dr. Ambrosino)
plasma screening
Plasma Screening
  • Units screened by Complement Fixation Assay (positive at 1:50 dilution)
  • Both pheresis and recovered plasma used
complement fixation assay
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
manufacturing process
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
slide7

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

potency assay since 1984
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
potency assay
Potency Assay

Acceptance criteria:

  • In-house standard titer: 8192

(allowed range: 4096 – 16384)

  • Final vial specification:

potency ratio:  0.8 x in-house standard

massachusetts biologic laboratories university of massachusetts medical school
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
td shortage the pink sheet february 26 2001
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)

entering the new field of monoclonal antibody mab development
Entering the New Field of Monoclonal Antibody (MAB) Development
  • Orphan Products (a.k.a. too small for big pharmaceutical companies)
  • Urgent public health need
mbl blood products
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)
supply annual vzig vials sent to distributor or actual sales in blue 1978 2005
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

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