SYMPOSIA ON MONDAY, 8 OCTOBER 2012, 1:00–5:00 PM

#1: Biosimilars: Defining Successful Development Strategies in an Evolving Regulatory Environment

#2: Best Practices for Implementation Challenges with Single-Use Systems

#3: Best Practices in Managing Variability of Raw Materials

#4: Regulatory Requirements in Preclinical CMC Development

#5: Best Practices in Cleaning and Cleaning Validation: A Science-Based and Integrated Approach for Biopharmaceuticals

#6: Risk Management in Fill–Finish Operations

#7: CMC Project Management throughout the Product Development Life Cycle

#8: Microbial Protein Production Systems

XCELLEREX SITE TOUR
THURSDAY, 11 OCTOBER 2012
1:30–4:30 PM

EXHIBIT HALL HOURS
Tuesday 3:15–7:00 PM   Wednesday 9:45 AM–7:15 PM   Thursday 9:45 AM–1:40 PM

DEDICATED POSTER VIEWING
Wednesday 12:30–1:45 PM

TWO-DAY TRAINING COURSES TAKE PLACEON TUESDAYAND WEDNESDAY, 9–10 OCTOBER 2012, 9:00–5:00 PM

For details about the course agendas and instructors, visit www.IBCLifeSciences.com/courses.

Introduction to Biopharmaceutical and Vaccine Manufacturing with Sue Behrens (independent consultant; former senior director of vaccines and biologics for Merck’s Manufacturing Division)

Analytical Method Development and Validation for Therapeutic Proteins with Jichao Kang (director of analytical and formulation development at Laureate Biopharmaceutical Services, Inc.)

Cell Culture and Fermentation Bioprocessing with Antonio R. Moreira (professor of chemical and biochemical engineering and vice provost of the University of Maryland in Baltimore County)

Antibody Engineering with David Bramhill (founder of Bramhill Biological Consulting, LLC and Research Corporation Technologies)

Stability and Specifications for Biological and Biotech Products with Timothy Schofield (managing director and head of nonclinical statistical services at Arlenda, Inc.)