USP Enzyme Workshop

This two-day workshop highlighted some of the major scientific and regulatory challenges associated with enzymes and their relation to pharmaceuticals, foods, and dietary supplements. Participants discussed overarching standardization issues, including unit assignment and maintenance, assay development and validation, reagent quality, and use of reference materials.

Topics:

• Enzymes in the pharmaceuticals, foods, and dietary supplements
• Enzyme scientific issues
• Enzymes in orphan diseases
• Enzymes as therapeutics
• USP pancrelipase update
• Enzyme special topics—proteases
• Pepsin as case study for method and unit harmonization

When: July 8–9, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

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

Participants: Scientists, researchers, manufacturers, regulators, and quality control professionals who work with enzymes in the formulation of pharmaceuticals, dietary supplements, and/or foods.