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October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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August 21-22, 2012
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Novel Approaches and Applications for Viral Clearance
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:30
Networking Coffee
Novel Approaches and Applications for Viral Clearance
8:00
Co-Chairpersons' Remarks
Katherine F. Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories, Inc.
Joseph P. Martin Jr., Ph.D., Research Fellow, Purification Process Development, Pfizer Inc.
Katherine F. Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories, Inc.
Joseph P. Martin Jr., Ph.D., Research Fellow, Purification Process Development, Pfizer Inc.
8:15
Future of Viral Clearance
Viral clearance studies are an integral part of the safety testing program for biopharmaceuticals. This presentation will focus on current trends in viral clearance studies including: the importance of well characterized virus stocks, the application of quality by design principles to viral clearance studies, the use of worst-case model viruses to mimic recent contamination events, viral inactivation programs for raw materials, and the role of cleaning validation studies in a viral safety program.
Katherine F. Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories, Inc.
Viral clearance studies are an integral part of the safety testing program for biopharmaceuticals. This presentation will focus on current trends in viral clearance studies including: the importance of well characterized virus stocks, the application of quality by design principles to viral clearance studies, the use of worst-case model viruses to mimic recent contamination events, viral inactivation programs for raw materials, and the role of cleaning validation studies in a viral safety program.
Katherine F. Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories, Inc.
Unpublished Data
8:45
Case
Study
Implementation of Viral Barriers for a Non-Platform, Commercial Cell Culture ProcessStudy
A significant concern for biologics manufacturing is the introduction of adventitious agents such as viruses and resulting infection of the mammalian cells used in large-scale cell culture processes. Genentech employs a series of barriers designed to mitigate the various risks in large-scale cell culture processes. High temperature short time (HTST) treatment of cell culture media is an important part of Genentech's risk mitigation strategy against the introduction of viral agents via raw materials, and has been shown to be effective for viral inactivation. Here we present a case study describing the implementation of HTST treatment for a non-platform, commercial antibody production process. Cell culture media components were screened at bench-scale to explore susceptibility to thermal treatment. The results of the screening were further confirmed by HTST tests performed at large-scale and the necessary procedural modifications in media preparation process were implemented. Extensive cell culture characterization studies performed using a scale-down bioreactor system indicate that HTST-treated media results in comparable product quality as well as process performance. This presentation will discuss the importance and the technical feasibility of process modifications required for viral risk mitigation of production-scale mammalian cell culture processes.
Salim Charaniya, Ph.D., Engineer II, Manufacturing Sciences and Technology, Genentech, Inc.
Unpublished Data
9:15
Case
Study
Defining the Design Space for Two Chromatography Steps Using a DOE Approach to Viral ClearanceStudy
Statistical Design of Experiment (DOE) maximizes the information obtained for a given experimental effort. Additionally, well-designed experiments can formalize the concept of "bracketing" the input parameter range consistent with acceptable product quality. We have applied Circumscribed Central Composite Designs to generate quantitative models of linear, non-linear, and interactive effects of input parameters on viral clearance in two chromatographic purification steps.
Mary Ellen Dahlgren, M.S.
9:45
Networking Refreshment Break in Exhibit and Poster Hall
Unpublished Data
10:30
The Application of Modular Validation for Clinical Products
Lenore Norling, Manager, Process Virology, Genentech, Inc.
Lenore Norling, Manager, Process Virology, Genentech, Inc.
Unpublished Data
11:00
Detergent Viral Inactivation as a Robust Viral Clearance Step
Detergent viral inactivation has been a dedicated viral clearance step in the Lilly process for monoclonal antibodies for many years. This presentation shares our experience in the characterization of various parameters that are important for inactivation kinetics, overall log reduction, and the robustness of this unit operation.
Michelle Quertinmont, Consultant Biologist, Virology and Purification Development, Eli Lilly and Company
Detergent viral inactivation has been a dedicated viral clearance step in the Lilly process for monoclonal antibodies for many years. This presentation shares our experience in the characterization of various parameters that are important for inactivation kinetics, overall log reduction, and the robustness of this unit operation.
Michelle Quertinmont, Consultant Biologist, Virology and Purification Development, Eli Lilly and Company
Unpublished Data
11:30
Case
Study
Process Stream Contaminants Compromise Viral Clearance Over AIEX: Superior Performance of Capto Q Relative to Q SepharoseStudy
Anion exchange (AIEX) generally provides 5-7 logs of viral clearance during mAb processing. During scaleup we discovered that AIEX feedstream contaminants levels had increased and the viral clearance through the step was lost. Capto Q was significantly better than Q Sepharose in preserving viral clearance. Loss of clearance was associated with an upturn in UV absorption which was caused by unloading of DNA and HCP. Pre-removal of contaminants from the AIEX feedstream enabled high loads on Capto Q while preserving 5-7 logs of viral clearance at manufacturing scale.
Joseph P. Martin Jr., Ph.D., Research Fellow, Purification Process Development, Pfizer Inc.
12:30
Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Poster presenters are requested to stand by their posters for discussion.
Keynote Presentations
4:15
Bioprocess Technology & Innovation: Strategic Imperative for Challenging TimesCan bioprocess innovation continue to be an important strategic advantage and generate value? What drivers should inform a meaningful technology and innovation strategy, and what approaches and infrastructure are needed to support it? The changing landscape has brought many new challenges, including vastly decentralized research and idea creation, virtual companies, novel treatment modalities, an expansion of viable production technologies, biosimilars, regionalization and globalization, and a complex regulatory and intellectual property environment. From the perspective of a large global biopharma company, developing and implementing an aggressive, multifaceted strategy is essential; examples and perspective on the journey will be provided.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
5:00
Integrating Two Biologics Manufacturing NetworksThe Roche Group acquired Genentech in March 2009, resulting in the integration of two distinct biologics manufacturing networks. The challenge of integrating these two organizations required addressing people, process and technologies across the entire supply chain from raw material sourcing through delivery to patients. The manufacturing operations of these two companies recognized that that integration takes as much focus on decision-making governance and company culture as it does on physical assets, operations and organization.
Tim Moore, Senior Vice President, Global Head, Pharmaceutical Technical Operations Biologics, Roche
5:45
Networking Reception in Poster and Exhibit Hall
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