Allergenic Products Advisory Committee, March 15, 2002

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Allergenic Products Advisory Committee, March 15,
2002

• Lab overview
• Research update
• Site visit summary
• Rabins projects
• Particulates update
• compliance update
• TSE update
• Recombinant allergens
• Glycerol

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Laboratory of Immunobiochemistry

• Operational issues

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• Principal Investigators
• Jay E. Slater, MD, Lab Chief Supervisory
  Medical Officer (3)
• Ronald Rabin, MD - Senior Staff Fellow (lt1)
• Lyudmila Soldatova, PhD - Visiting Scientist (4)
•  
• Post Doctoral Fellows
• Jonny Finlay, PhD - IRTA (1)
• Hui Huang, MD - Visiting Associate (lt1)
•  

4

• Research Technicians
• Melissa Patterson- Biologist (2)
• Albert Gam Biologist (1)
• Mona Febus Microbiologist (2)
• Marc Alston Biologist (1)
• Cherry Valerio Biologist (1)
• Katia Dobrovolskaia - IRTA (lt1)
•  
• Fellows/Guest Workers
• Bhavini Trivedi, MD - NIH Fellow (lt1)
• Gerry Poley, MD Guest Worker (3)
• Li-Shan Hsieh, PhD Guest Worker (3)

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LIB staffing 1998-2002
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Routine regulatory activities

• Lot release
• Reference development
• Reference distribution
• Reference maintenance
• semiannual checks
• replacement

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• Lot release activities
• 406 protocols submitted and reviewed
• 2 withdrawn
• Reference distribution
• 2001 2151 vials in 101 shipments sent to
  manufacturers

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Reference replacement
Reference extract Sent to manufacturers Manufacturers responding Date shipped
E4 cat hair 4/2/01 7 7/23/01
C10 cat 8/27/01 5 11/12/01
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Publications

• Patterson ML, Slater JE. Characterization and
  comparison of commercially available German and
  American cockroach allergen vaccines. Clin Exp
  Allergy (in press)
• Sutherland MF, Drew A, Rolland JM, Slater JE,
  Suphioglu C, O'Hehir RE. Specific monoclonal
  antibodies and human IgE show Hev b 5 is an
  abundant allergen in high protein powdered latex
  gloves. Clin Exp Allergy (in press)
•  

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Publications (reviews)

• Morrow KS, Slater JE. Regulatory aspects of
  allergen vaccines in the US. Clin Rev Allergy
  Immunol 2001 21141-152.
• Lockey RF, Slater JE, Esch R. Preparation and
  standardization of allergen vaccines. In
  Middletons Allergy Principles and Practice, 6th
  ed. St. Louis Mosby (in press).

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Abstracts

• Patterson ML, Cardinale EJ, OHehir RE,
  Sutherland MF, Slater JE. Hev b 5 double mutant
  proteins. J Allergy Clin Immunol 2002. 
• Valerio C, Solanki MD, Slater JE. The effects of
  intratracheal lipopolysaccharide (LPS) on the
  cytokine responses of Balb/C mice to ovalbumin. J
  Allergy Clin Immunol 2002. 
• Alston M, Valerio C, Morrow K, Dixon A, Slater
  JE. Lyophilization does not affect the activity
  or secondary structure of cat allergen vaccines.
  J Allergy Clin Immunol 2002.  
• Soldatova LN, Marcovic-Housley Z, Mueller UR,
  Slater JE. The role of glycosylation in the IgE
  binding of the major honeybee allergen,
  hyaluronidase. J Allergy Clin Immunol 2002. 
• Finlay WJJ, Slater JE. Analysis of IgE heavy
  chain sequences from a small volume of peripheral
  blood from a mildly atopic individual. J Allergy
  Clin Immunol 2002.  
• Hsieh LS, Moharram RM, Akasawa A, Slater J,
  Martin BM, Banana allergen detection and
  identification using SELDI technology. J Allergy
  Clin Immunol 2002.
• Rabin RL, Alston, M, Cooley, J, and Farber, JM.
  Dual roles for the chemokine receptor CXCR3 in
  adaptive immunity. J Allergy Clin Immunol 2002.