September 14-16, 2010
Ocean Place Resort - Long Branch, NJ

Leveraging Advanced Chemical Technologies for Robust, Efficient Production and Development

Monday, September 14
1:30 - 5:30

Meeting the QbD Challenge: A Tailored Approach in Process R&D
Niklaus Bieler, Senior Scientist, Exclusive Synthesis R&D, Lonza
The Quality by Design (QbD) framework has a clear focus on processes and product understanding with the aim to develop robust processes upfront to prevent poor quality later in the product lifecycle. A key challenge for process R&D is to apply QbD during the development phase in a way that is tailored to the specific needs and challenges of individual products.

15 Minute Refreshment Break

Manufacturing ADCs: Potent New Weapons for the Oncology Arsenal
Tom Rohrer, Senior Director, ADCs and Biochemical Technologies, Lonza
Manufacturing antibody drug conjugates (ADCs) presents a series of unique engineering and chemistry challenges for even the most experienced biopharmaceutical manufacturer. Safe, high-quality and cost-effective production requires extensive experience in both biopharmaceuticals and small molecule drug process development and scale-up, as well as the appropriate procedures and equipment.

15 Minute Refreshment Break

Industrial Applications of Microreactor Technology
Dominique Roberge, Microreactor Specialist, Lonza
Microreactor technology is currently redefining the way many small molecules are manufactured. This presentation will focus on the economical outcomes of using microreactor technology in an industrial context as well as the additional advantages, such as reduction in labor costs, quick change-over (high flexibility) in system setup, and fast kg-ton scale productions. The analysis is based on several years of manufacturing experience using a wide range of leading and proprietary technologies and will be presented using a real case study.

RSVP required for the workshop by August 28. Please email confirmation to info@chemoutsourcing.com

Beach Party 6:00 - 10:00 Open to all registered attendees