Session 22:
Regulatory Issues in Biotech (roundtable format, 90-minutes)
Wednesday, July 23, 2014: 8:30 AM-11:30 AM
Regency Ballroom E, Second Floor (St. Louis Hyatt Regency at the Arch)
Convener:
Carsten Hjort - Novozymes A/S, Bagsvaerd,
The regulatory environment in Industrial Biotechnology has changed dramatically during the past 10 years. New regulatory frameworks like FIAP (Food Improvement Agents Package) in Europe have forced biotech companies to rethink their regulatory strategies. The approval strategy has to be integrated even into the early stage of product development as both production organism and the production process needs to be aligned with current regulatory requirements. This is the case for enzyme products for food and feed, but it also applies for more technical applications. In future bio refineries, highly efficient enzyme products are needed for hydrolysis of cellulose and hemicellulose. As these enzyme products needs to be low cost, enzyme recovery and formulation may be very different from traditional enzyme products. Engineered microorganisms convert the carbohydrate to the desired products in a facility with limited containment. Finally side streams containing residuals of the enzyme products and engineered microorganisms may be used as feed additives. The regulatory implications of these changes will be discussed.
