Allergenic Products Advisory Committee, March 15, 2002 n Lab overview n Research update Site visit summarySite visit summary Rabins projectsRabins projects n Particulates update compliance updatecompliance update n TSE update n Recombinant allergens n Glycerol

Laboratory of Immunobiochemistry Operational issues

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

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

LIB staffing

Routine regulatory activities n Lot release n Reference development n Reference distribution n Reference maintenance semiannual checkssemiannual checks replacementreplacement

n Lot release activities 406 protocols submitted and reviewed406 protocols submitted and reviewed 2 withdrawn2 withdrawn n Reference distribution 2001: 2151 vials in 101 shipments sent to manufacturers2001: 2151 vials in 101 shipments sent to manufacturers

Reference replacement Reference extract Sent to manufacturers Manufacturers responding Date shipped E4 cat hair 4/2/0177/23/01 C10 cat 8/27/01511/12/01

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)

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

Abstracts Patterson ML, Cardinale EJ, OHehir RE, Sutherland MF, Slater JE. Hev b 5 double mutant proteins. J Allergy Clin Immunol Patterson ML, Cardinale EJ, OHehir RE, Sutherland MF, Slater JE. Hev b 5 double mutant proteins. J Allergy Clin Immunol 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 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 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 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 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 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 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 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 Hsieh LS, Moharram RM, Akasawa A, Slater J, Martin BM, Banana allergen detection and identification using SELDI technology. J Allergy Clin Immunol Rabin RL, Alston, M, Cooley, J, and Farber, JM. Dual roles for the chemokine receptor CXCR3 in adaptive immunity. J Allergy Clin Immunol 2002.