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Pipeline 2 : Protein Production Day 1
Proteins’ complexity makes scaling up and transferring processes particularly onerous. In the Protein Production meeting, we will explore the innate protein challenges, as we walk through case studies ranging from small scale to manufacturing. Along the way, we will investigate whether fed batch or perfusion is the best technology choice, what cell lines are least problematic, and how bioreactor design can impact yield. The meeting will also bring the issue of single-use systems into the discussion addressing how to achieve greater productivity of quality product. In the Protein Production meeting, protein experts will help you develop processes that scale up production to reach higher yields while avoiding costly mistakes. Thursday, January 14 1:15 Registration for Protein Production
OPTIMIZING PROCESSES TO SUPPORT PRODUCTION 1:45 Chairperson’s Opening Remarks 1:50 Opening Keynote Presentation Shishir Gadam, Ph.D., Director, Manufacturing Science and Technical Services, Vacaville Operations, Genentech 2:20 Process Characterization: A Case Study Involving Problematic HCP’s and Unique Product-Related Impurities Robert L. Dufield, Principal Scientist, Analytical R&D: Protein Impurity Characterization, Pfizer, Inc. The challenge of process characterization requires the development and implementation of a comprehensive set of analytical tools to accurately define the process and ultimately improve product quality. A case study is provided where product co-purifying host cell proteins (HCPs) and a variety of product variants were isolated and characterized. In general, the identification of these impurities was primarily accomplished by utilizing a combination of proteolytic mapping and mass spectrometry. Aside from identifying various HCPs, some of the unique product-related impurities identified include norleucine misincorporation, site-specific truncations, and an unusual Ala-Pro for Leu-Leu misincorporation due to a double frameshift event. Subsequently, the deletion of various genes from the original host strain and traditional process optimization resulted in an efficient and robust manufacturing process and an improved understanding of product quality. 2:50 High-Throughout Automated Parallel Production of Spatially Addressed Antibody Combinatorial Libraries for Drug Discovery James Graziano, Ph.D., Chief Operating Officer, Protein Sciences, Fabrus LLC We have created spatially addressed protein libraries and a process pipeline that utilizes an automated protein expression and purification platform supporting the production of 500 highly pure proteins every five days. Spatially addressing the elements allows downstream screening design to mimic that of traditional small molecule screening instead of the more common display-based methods of biologic selection and allows direct screening in cell-based assays. 3:20 Sponsored Presentation (Sponsorship Opportunity Available) 3:35 Networking Refreshment Break in the Exhibit Hall 4:30 Zera-Fusions and Storpro Organelles Enable Novel Protein Products and Processes Stefan Schmidt, Ph.D., Vice President, Technology, ERA Biotech ERA Biotech has developed a versatile bioprocess, relying on a peptide motif that triggers the in vivo encapsulation of functional recombinant protein in storage organelles. This unique protein accumulation is applicable in a broad variety of eukaryotic hosts, protecting cells from toxic products, simultaneously shielding the proteins from proteolysis. The organelles can be recovered and concentrated in a one-step process from cells, enabling a highly simplified purification. We expressed a wide range of therapeutic and industrial proteins in parallel and demonstrate several novel applications. 5:00 Implementation Strategy for Disposables – Downstream Purification Case Study Adam Goldstein, Ph.D., Senior Manager, Clinical Operations, Genentech, Inc. The presentation begins by offering an introduction to the reasoning behind disposable system implementation. This highlights the time and money saved by switching from stainless steel systems to disposable systems which is due to (among other things) decreased validation testing, cleaning requirements, and cross contamination as well as quicker turnaround times between runs. This talk will explore the steps necessary in implementing disposables into a process; How to form an effective implementation team, Designing a disposable system to fit a process, Development of a validation plan. This talk will focus on the implementation of disposables into the mfg. process. This talk will provide a specific example of the benefits of disposables by highlighting the environmental and cost savings that have been associated with implementation of disposables at Genentech’s Oceanside Clinical Plant. Included in this case study is a look at the implementation of freeze-bulk disposable containers (a relatively novel application in the disposables industry) at the Oceanside Clinical Plant. 5:30 Interactive Panel Discussion Implementing and Optimizing Single-Use/Disposable Technology Disposables have proven their benefits when used in all phases of Bioprocessing. However, implementing ‘all disposable’ processes pose numerous challenges. This panel discussion will address both the science and the logistics of phasing in and depending on single-use technologies for scaling up protein processes. Moderator: Adam Goldstein, Ph.D., Senior Manager, Clinical Operations, Genentech, Inc.
6:00 Close of Day ____________________________________________________________________________________________ Recommended Short Courses*
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