Enzyme Workshop

July 8 – 9, 2009
USP Headquarters, Rockville, Maryland

Overview

Enzyme standards exist in both the United States Pharmacopeia–National Formulary (USP–NF) and the Food Chemicals Codex. In the USP-NF, enzyme monographs are primarily for enzymes as digestive aids (pancrelipase, trypsin, papain). In the pharmaceutical and biotechnology areas, enzymes are of increasing importance as reagents (peptide mapping, deglycosylation) or as ancillary materials in the processing of tissues or cells. For foods, enzymes have a longstanding use, especially in milk products. Some enzymes are used as dietary supplements (pepsin, papain). Many of the standardization issues for enzymes are overarching: unit assignment and maintenance, assay development and validation, reagent quality, and use of reference materials. USP is holding an interactive 2-day workshop that will highlight some of the major scientific and regulatory challenges pertaining to enzymes.

Agenda

Click here (46KB) for the final workshop agenda (as of July 8, 2009)

Presentations

Enzymes in Pharmaceuticals, Foods & Dietary Supplements (694KB): Roger L. Williams
Enzyme Replacement Therapies (243KB): Emanuela Lacana
Special Challenges for Enzyme Assays (1.5MB): Charles S. Craik
Role of the Compendia and Standards (395KB): William Koch
The Use of Enzymes in Dietary Supplements (177KB): Nena Dockery
Enzymes in Food Manufacturing (645KB): Chris Penet
Enzyme Unit Assignment and Maintenance, Reference Materials and International Harmonization (906KB): Tina S. Morris
Perspectives on Enzyme Products in The Japanese Pharmacopoeia (1.4MB): Teruhide Yamaguchi
Safety Evaluation of Enzymes in the EU (648KB): Anne Theobald
An Industry Perspective: Enzyme Technical Association (115KB) by Gary L. Yingling
Challenges in Therapeutic Enzyme Manufacturing (545KB): Gibbes Johnson
Development of Assays for an Enzyme Indicated for Potential Treatment of Celiac Disease (1.1MB): Pawan Kumar
Lipases – measurement and substrate challenges (1.3MB): Jo Demeester
Factors Affectign Lipase Activity (521KB): Andrew Halton
USP Pancrelipase Update (181KB): Mary Crivellone
USP Pancrelipase Update (521KB): Alexey Khrenov
Proteases in the Food Industry (767KB): Peter Birschbach
Enzymes as Tools for Producing Cells for Clinical Therapies (5.6MB): David W. Scharp
Enzyme Reagents for Analytical Protein Characterization (340KB): David M. Bunk
Pepsin as a Case Study for Method and Unit Harmonization (662KB): Thomas K. Langdon
Pepsin – Standardization Challenges (567KB): Alexey Khrenov

Contact Information

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