LIB site visitLIB site visitJanuary 24, 2002January 24, 2002

Jay E. Slater, MDJay E. Slater, MD

Laboratory of ImmunobiochemistryLaboratory of Immunobiochemistry

FDA/CBER/OVRR/DBPAPFDA/CBER/OVRR/DBPAP

History of LIBHistory of LIB

Laboratory of Allergenic Products, Division of Laboratory of Allergenic Products, Division of Bacterial ProductsBacterial Products

Laboratory of Immunobiochemistry, Division Laboratory of Immunobiochemistry, Division of Allergenic Products and Parasitologyof Allergenic Products and Parasitology• Allergenic Products Testing LabAllergenic Products Testing Lab• Allergenic Products Research LabAllergenic Products Research Lab

Laboratory of Immunobiochemistry, Division Laboratory of Immunobiochemistry, Division of Bacterial Parasitic and Allergenic Productsof Bacterial Parasitic and Allergenic Products

LIB missionLIB mission

LIB supports the regulatory mission of CBER and LIB supports the regulatory mission of CBER and FDA in assuring the safety and efficacy of FDA in assuring the safety and efficacy of allergenic products in the US by allergenic products in the US by 1. performing original research in the fields of allergen structure 1. performing original research in the fields of allergen structure

and function, and immunomodulationand function, and immunomodulation 2. responding to specific regulatory needs with directed research 2. responding to specific regulatory needs with directed research

projectsprojects    3. providing expert advice and support for CBER and FDA staff 3. providing expert advice and support for CBER and FDA staff

regarding allergy and allergenic productsregarding allergy and allergenic products 4. reviewing, confirming and approving lot release data from 4. reviewing, confirming and approving lot release data from

allergenic product manufacturers allergenic product manufacturers 5. assisting in the review of BLAs and INDs that relate to 5. assisting in the review of BLAs and INDs that relate to

allergenic productsallergenic products

LIB is in NIH, Building 29, in the LIB is in NIH, Building 29, in the basement and on the 2basement and on the 2ndnd floor floor

211

B3 B1

214-218212203

EquipmentEquipment

tissue culture hoodstissue culture hoods chemical hoodschemical hoods centrifugescentrifuges COCO22 incubators incubators light microscopeslight microscopes thermocyclersthermocyclers vertical and horizontal electrophoresis apparatuses and vertical and horizontal electrophoresis apparatuses and

power sourcespower sources UV and light spectrophotometersUV and light spectrophotometers balancesbalances pH meterspH meters

More equipmentMore equipment

mouse plethysmographmouse plethysmograph fluorescent imagerfluorescent imager magnetic cell sortermagnetic cell sorter flow cytometer (room 513)flow cytometer (room 513)

Core facilities (Buildings 29, 29A Core facilities (Buildings 29, 29A and Nicholson Lane)and Nicholson Lane)

DNA sequencingDNA sequencing oligonucleotide primer synthesisoligonucleotide primer synthesis peptide synthesispeptide synthesis N-terminal sequencingN-terminal sequencing mass spectrometry analysismass spectrometry analysis amino acid compositionamino acid composition lyophilizationlyophilization

Shared equipmentShared equipment

gene expression microarraygene expression microarray circular dichroism spectrometer circular dichroism spectrometer (Building 5)(Building 5)

NMR spectrometers (300 MHz and 500 NMR spectrometers (300 MHz and 500 MHz; 700 MHz on order)MHz; 700 MHz on order)

Scientific goalsScientific goals

Allergen structure and functionAllergen structure and function Immunomodulation of allergic Immunomodulation of allergic

responsesresponses Preparation and preservation of Preparation and preservation of

reference standardsreference standards

Scientific goalsScientific goalsAllergen structure and function

Modifying allergic responses

Extract preservation and potency determinations

Latex, cockroach, hymenoptera

LPS

RSV, MDR

Lyophilization

Precipitates in allergen extracts

MALDI-TOF of allergen extracts

Cross-reactivity between foods and latex

SELDI technology in identification of allergens

PAR-2 activation in mast cells

Scientific goalsScientific goalsAllergen structure and function

Modifying allergic responses

Extract preservation and potency determinations

Latex, cockroach, Latex, cockroach, hymenopterahymenoptera

LPSLPS

RSV, MDRRSV, MDR

Lyophilization

Precipitates in allergen extracts

MALDI-TOF of allergen extracts

Cross-reactivity between foods and latex

SELDI technology in identification of allergens

PAR-2 activation in mast cells

Scientific goalsScientific goalsAllergen structure and function

Modifying allergic responses

Extract preservation and potency determinations

Latex, cockroach, hymenoptera

LPS

RSV, MDRRSV, MDR

Lyophilization

Precipitates in allergen extracts

MALDI-TOF of allergen extracts

Cross-reactivity between foods and latex

SELDI technology in identification of allergens

PAR-2 activation in mast cells

LIB research programLIB research programResearchResearch RegulatoryRegulatory

Latex, cockroach, Latex, cockroach, hymenopterahymenoptera

Regulation of recombinant Regulation of recombinant allergens; immunotherapy optionsallergens; immunotherapy options

LPSLPS Adjuvant safety and efficacy Adjuvant safety and efficacy

Extract potency determination Extract potency determination methodsmethods

Lot release for current and future Lot release for current and future productsproducts

Extract preservationExtract preservation US standard reference US standard reference maintenancemaintenance

RSVRSV Parameters of effective Parameters of effective immunomodulationimmunomodulation

MDRMDR Novel approaches to Novel approaches to immunotherapyimmunotherapy

Technical capabilitiesTechnical capabilities

ProjectProject Primary tools and Primary tools and capabilitiescapabilities

latexlatex

hymenopterahymenoptera

protein analysis protein analysis

DNA amplification/analysisDNA amplification/analysis

cloning and mutagenesiscloning and mutagenesis

cockroachcockroach combinatorial IgE librarycombinatorial IgE library

LPSLPS plethysmographyplethysmography

RSVRSV

MDRMDR

flow cytometryflow cytometry

cell sortingcell sorting

LIB technicians are involved in LIB technicians are involved in research and regulationresearch and regulation

PositionPosition Research activityResearch activity

Marc AlstonMarc Alston BiologistBiologist RSV, RSV, lyophilizationlyophilization

Mona FebusMona Febus MicrobiologistMicrobiologist hymenopterahymenoptera

Albert GamAlbert Gam BiologistBiologist hymenopterahymenoptera

Melissa PattersonMelissa Patterson BiologistBiologist latex, cockroach, latex, cockroach, precipitatesprecipitates

Cherry ValerioCherry Valerio BiologistBiologist LPS, lyophilizationLPS, lyophilization

Rabin presentationsRabin presentations

Characterization of responses to RSV Characterization of responses to RSV by T-cells from human tonsil (Rabin and by T-cells from human tonsil (Rabin and Alston)Alston)

Modification of multidrug resistance Modification of multidrug resistance protein activity as a potential protein activity as a potential mechanism of immunomodulation mechanism of immunomodulation (Rabin and Huang)(Rabin and Huang)

Soldatova presentationsSoldatova presentations

Glycosylation and the allergenicity of Glycosylation and the allergenicity of honeybee venom hyaluronidase honeybee venom hyaluronidase (Soldatova, Gam and Dobrovolskaia)(Soldatova, Gam and Dobrovolskaia)

Cloning of a new bee venom allergen, Cloning of a new bee venom allergen, acid phosphatase (Soldatova and acid phosphatase (Soldatova and Dobrovolskaia)Dobrovolskaia)

Slater presentationsSlater presentations

The effects of LPS on allergen responses The effects of LPS on allergen responses (Slater, Valerio and Trivedi)(Slater, Valerio and Trivedi)

Modification of the latex allergen Hev b 5 Modification of the latex allergen Hev b 5 for the immunotherapy of latex allergy for the immunotherapy of latex allergy (Slater and Patterson)(Slater and Patterson)

Molecular characterization of the immune Molecular characterization of the immune response to cockroach allergens (Finlay, response to cockroach allergens (Finlay, Slater and Patterson)Slater and Patterson)