WEDNESDAY, NOVEMBER 19
8:00am Morning Coffee
Separation at Scale: Chromatography and Crystallization
(Shared session with Drug Formulation Conference)
8:30 Chairperson’s Remarks
Orn Almarsson, Ph.D., Vice President of Pharmaceutical Chemistry, Alkermes Inc.
8:35 Supercritical Fluid Chromatography (SFC) as an Isolation Tool for By-Product and Impurity Identification
Todd Zelesky, Scientist, Development Analytical Department, Pfizer Inc.
As a drug moves successfully through the development stages of the pipeline it becomes increasingly important to identify drug related impurities. By-product structural information can be instrumental to the process chemists in moving forward with key reaction optimization decisions. Supercritical Fluid Chromatography (SFC) is an isolation and purification tool that allows for targeted impurities to be isolated quickly. SFC has many notable advantages over HPLC for the isolation of reaction impurities, including cost effectiveness and speed.
9:05 Case Studies of Analytical Challenges in API Process Research & Development
Yong Chen, Ph.D., Research Investigator, Process Analytical Chemistry, Process R&D, Global Pharmaceutical R&D, Abbott Laboratories
Analytical strategies for the investigation and control of process-related impurities during the development of scaled-up API processes will be discussed. Emphasis will be focused on orthogonal method development and innovative chromatographic approaches coupled with modern detection technologies. Case studies will demonstrate efficient approaches toward understanding and tracking the origin, fate, and rejection of critical impurities in the entire scale-up processes.
9:40 Networking Coffee Break, Poster and Exhibit Viewing
10:15 Pharmaceutical Co-Crystals: History and Relevance to Drug Development
Orn Almarsson, Ph.D., Vice President of Pharmaceutical Chemistry, Alkermes Inc.
The aim of this presentation will be to provide perspective on the recent development of the field of pharmaceutical co-crystals. Prior to 2002, this field was dormant, with a few examples of pharmaceutically relevant co-crystals scattered in the literature. A surge of interest ensued in 2002, spurred in part by productivity concerns and demand for innovation in pharmaceutical R&D. Areas of impact of pharmaceutical co-crystal technology will be discussed, including tailoring materials for improved product performance, processing and separations.
10:45 Scaling-Up Co-Crystal Crystallizations
Renato Chiarella, Ph.D., Scientist, Formulation Development, Johnson & Johnson Pharmaceutical Research and Development
11:15 Close of Conference*
*Attendees are invited to stay at no extra cost until the end of the day to attend the beginning of the Drug Formulation conference; or register to attend the entire Drug Formulation conference and Mastering Process Chemistry at a discounted rate.