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Allergenic Products Advisory Committee, March 15, 2002

Allergenic Products Advisory Committee, March 15, 2002. Lab overview Research update Site visit summary Rabin’s projects Particulates update compliance update TSE update Recombinant allergens Glycerol. Laboratory of Immunobiochemistry. Operational issues. Principal Investigators

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Allergenic Products Advisory Committee, March 15, 2002

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  1. Allergenic Products Advisory Committee, March 15, 2002 • Lab overview • Research update • Site visit summary • Rabin’s projects • Particulates update • compliance update • TSE update • Recombinant allergens • Glycerol

  2. Laboratory of Immunobiochemistry Operational issues

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

  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 (<1) • Fellows/Guest Workers • Bhavini Trivedi, MD - NIH Fellow (<1) • Gerry Poley, MD – Guest Worker (3) • Li-Shan Hsieh, PhD – Guest Worker (3)

  5. LIB staffing 1998-2002

  6. “Routine” regulatory activities • Lot release • Reference development • Reference distribution • Reference maintenance • semiannual checks • replacement

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 Lot release activities • 406 protocols submitted and reviewed • 2 withdrawn • Reference distribution • 2001: 2151 vials in 101 shipments sent to manufacturers

  8. Reference replacement

  9. 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)

  10. Publications (reviews) Morrow KS, Slater JE. Regulatory aspects of allergen vaccines in the US. Clin Rev Allergy Immunol 2001; 21:141-152. Lockey RF, Slater JE, Esch R. Preparation and standardization of allergen vaccines. In Middleton’s Allergy: Principles and Practice, 6th ed. St. Louis: Mosby (in press).

  11. Abstracts Patterson ML, Cardinale EJ, O’Hehir 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.

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