# Presentation: 300212

## LIB site visitJanuary 24, 2002

*Jay E. Slater, MD*
*Laboratory of Immunobiochemistry*
*FDA/CBER/OVRR/DBPAP*

## History of LIB

*Laboratory of Allergenic Products, Division of Bacterial Products*
*Laboratory of Immunobiochemistry, Division of Allergenic Products and Parasitology*
*Allergenic Products Testing Lab*
*Allergenic Products Research Lab*
*Laboratory of Immunobiochemistry, Division of Bacterial Parasitic and Allergenic Products*

## LIB mission

*LIB supports the regulatory mission of CBER and FDA in assuring the safety and efficacy of allergenic products in the US by *
*1. performing original research in the fields of allergen structure and function, and immunomodulation** *
*2. responding to specific regulatory needs with directed research projects**  *
*3. providing expert advice and support for CBER and FDA staff regarding allergy and allergenic products** *
*4. reviewing, confirming and approving lot release data from allergenic product manufacturers *
*5. assisting in the review of BLAs and INDs that relate to allergenic products*

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

-    **211**

**       ****B3**

**   ****B1**

**   ****214-218**

**212**

**203**

## Equipment

*tissue culture hoods*
*chemical hoods*
*centrifuges*
*CO**2** incubators*
*light microscopes*
*thermocyclers*
*vertical and horizontal electrophoresis apparatuses and power sources*
*UV and light spectrophotometers*
*balances*
*pH meters*

## More equipment

*mouse plethysmograph*
*fluorescent imager*
*magnetic cell sorter*
*flow cytometer (room 513)*

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

*DNA sequencing*
*oligonucleotide primer synthesis*
*peptide synthesis*
*N-terminal sequencing*
*mass spectrometry analysis*
*amino acid composition*
*lyophilization*

## Shared equipment

*gene expression microarray*
*circular dichroism spectrometer **(Building 5)*
*NMR spectrometers (300 MHz and 500 MHz; 700 MHz on order)*

## Scientific goals

*Allergen structure and function*
*Immunomodulation of allergic responses*
*Preparation and preservation of reference standards*

## Scientific goals

- Allergen 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 goals

- Allergen structure and function

- Modifying allergic responses

- Extract preservation and potency determinations

- Latex, cockroach, hymenoptera

- LPS

- RSV, MDR

## Scientific goals

- Allergen structure and function

- Modifying allergic responses

- Extract preservation and potency determinations

- Latex, cockroach, hymenoptera

- LPS

- RSV, MDR

## LIB research program

| Research | Regulatory |
| --- | --- |
| Latex, cockroach, hymenoptera | Regulation of recombinant allergens; immunotherapy options |
| LPS | Adjuvant safety and efficacy  |
| Extract potency determination methods | Lot release for current and future products |
| Extract preservation | US standard reference maintenance |
| RSV | Parameters of effective immunomodulation |
| MDR | Novel approaches to immunotherapy |

## Technical capabilities

| Project | Primary tools and capabilities |
| --- | --- |
| latex
hymenoptera | protein analysis 
DNA amplification/analysis
cloning and mutagenesis |
| cockroach | combinatorial  IgE library |
| LPS | plethysmography |
| RSV
MDR | flow cytometry
cell sorting |

## LIB technicians are involved in research and regulation

|  | Position | Research activity |
| --- | --- | --- |
| Marc Alston | Biologist | RSV, lyophilization |
| Mona Febus | Microbiologist | hymenoptera |
| Albert Gam | Biologist | hymenoptera |
| Melissa Patterson | Biologist
 | latex, cockroach, precipitates |
| Cherry Valerio | Biologist
 | LPS, lyophilization
 |

## Rabin presentations

*Characterization of responses to RSV by T-cells from human tonsil (Rabin and Alston)*
*Modification of multidrug resistance protein activity as a potential mechanism of immunomodulation (Rabin and Huang)*

## Soldatova presentations

*Glycosylation and the allergenicity of honeybee venom hyaluronidase (Soldatova, Gam and Dobrovolskaia)*
*Cloning of a new bee venom allergen, acid phosphatase (Soldatova and Dobrovolskaia)*

## Slater presentations

*The effects of LPS on allergen responses (Slater, Valerio and Trivedi)*
*Modification of the latex allergen Hev b 5 for the immunotherapy of latex allergy (Slater and Patterson)*
*Molecular characterization of the immune response to cockroach allergens (Finlay, Slater and Patterson)*