Monday, September 15 - Day One

7:30 am Workshop Registration and Morning Coffee

12:00 pm Registration

OPTIMIZING CELL CULTURE CONDITIONS

1:30 Chairperson’s Remarks

1:45 USP Standards for Fetal Bovine Serum
Fouad Atouf, Ph.D., Scientist, Biologics & Biotechnology, United States Pharmacopeia
USP has formed an advisory panel to work specifically on the quality attributes of Fetal Bovine Serum (FBS), an important ancillary material, largely used in cell cultures in different areas of the biotechnology industry. The Fetal Bovine Serum ad hoc Advisory Panel has already developed and published in the Pharmacopeial Forum, General Information Chapter <1024> Bovine Serum describing issues related to the production, sourcing and characterization of bovine serum, with the intent to support users of bovine serum in conducting appropriate risk assessment and implementing risk-mitigation measures. In addition to this Chapter, the panel is developing a Test Chapter <090> Bovine Serum Specifications and Functionality Tests that addresses key quality attributes for serum products used in manufacturing of biologics and biotechnology-derived articles. This presentation will discuss the process USP uses to develop its documentary standards. It will also go into details on how the FBS quality attributes were selected and how laboratory testing is instrumental to assigning the specifications set in the USP documentary standards.

2:30 Drug Resistance Screening of Primary Human Tumors in Optimized Media that Closely Mimicks in vivo Conditions
Henriette Skribek, Ph.D., Researcher, Microbiology and Tumor Biology, Karolinska Institute

3:00 Preparing for the Onset of Screening in Primary and Stem Cell Lines: Optimizing the Scale-Up and Automation of Challenging Cell Lines for HTS
Alison Rush, Senior Research Associate, Department of Automated Biotechnology, Merck & Co.

3:30 Networking Refreshment Break with Poster and Exhibit Viewing

4:05 Moderated Small-Group Breakout Discussions
Join with your colleagues to discuss the crucial issues associated with culturing mammalian cells and scaling up production. Small-group discussions are a great way to network, exchange information, and develop collaborations. Each table topic is facilitated by an expert in the field, and discussions can be lively and spirited.

5:15 Roundtable Report Out – Each topic leader will present a brief report of the group’s discussion to the meeting delegates.

5:30 Reception with Poster and Exhibit Viewing (Sponsorship Available, Contact Ilana Schwartz at 781-972-5457 for more information)

6:30 End of Day One