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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Emerging Analytical Requirements
Emerging Analytical Requirements
- 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
7:00
Coffee
Emerging Analytical Requirements
Emerging Analytical Requirements and their Impact on Process Development and Manufacturing
8:00
Chairperson's Remarks
Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc.
Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc.
8:15
FDA Expectations Regarding Bioburden Control in Biotech Processes
Microorganisms can affect product quality attributes and lead to process and product failures. A well designed process can be derived from the systematic use of scientific and risk-based approaches, prior knowledge and the implementation of a pharmaceutical quality system. Elements of a well designed biotech process and appropriate control strategies for microbial control will be discussed.
Patricia F. Hughes, Ph.D., Biotech Manufacturing Team, Office of Compliance, CDER, U.S. Food and Drug Administration
Microorganisms can affect product quality attributes and lead to process and product failures. A well designed process can be derived from the systematic use of scientific and risk-based approaches, prior knowledge and the implementation of a pharmaceutical quality system. Elements of a well designed biotech process and appropriate control strategies for microbial control will be discussed.
Patricia F. Hughes, Ph.D., Biotech Manufacturing Team, Office of Compliance, CDER, U.S. Food and Drug Administration
New, Unpublished Data
8:45
Case
Study
Methods for Analysis of Subvisible Particles and the Utility in Biopharmaceutical Process EvaluationsStudy
Tristan Marshall, Research Associate III, Human Genome Sciences
9:15
Acidic Variants of Antibodies: Characteristics and PK Properties
Paul Motchnik, Ph.D., Associate Director, Protein Analytical Chemistry, Genentech, Inc.
Paul Motchnik, Ph.D., Associate Director, Protein Analytical Chemistry, Genentech, Inc.
9:45
Networking Refreshment Break in Exhibit and Poster Hall
10:30
Analytical Strategies for Monitoring Impurities Encountered in Bioprocessing
Monitoring of residual impurities encountered in bioprocessing can be quite challenging. Due to the range of potential impurities (antibiotics, surfactants/antifoams, etc.), many different analytical approaches may need to be employed. This presentation will explore some of the approaches taken to monitor low level impurities.
Jon S. Kauffman, Ph.D., Director, Method Development & Validation and Biopharmaceutical Services, Lancaster Laboratories
Monitoring of residual impurities encountered in bioprocessing can be quite challenging. Due to the range of potential impurities (antibiotics, surfactants/antifoams, etc.), many different analytical approaches may need to be employed. This presentation will explore some of the approaches taken to monitor low level impurities.
Jon S. Kauffman, Ph.D., Director, Method Development & Validation and Biopharmaceutical Services, Lancaster Laboratories
11:00
The Potency Assay -- Still Relevant after All These Years
The potency assay is the one product release/stability test that assesses the "bioactivity" of a specific lot at a specific time for biological/biotech therapeutics and therefore is required for these products. This talk will discuss how the role of potency assays has changed over time. It will also focus on common issues and timing (1) for choosing a potency assay from several candidate bioassays, (2) for developing, validating and maintaining this assay and (3) for trying to use this assay to assess neutralizing antibodies in patients or animals.
Sally Seaver, Ph.D., President, Seaver Associates, LLC
The potency assay is the one product release/stability test that assesses the "bioactivity" of a specific lot at a specific time for biological/biotech therapeutics and therefore is required for these products. This talk will discuss how the role of potency assays has changed over time. It will also focus on common issues and timing (1) for choosing a potency assay from several candidate bioassays, (2) for developing, validating and maintaining this assay and (3) for trying to use this assay to assess neutralizing antibodies in patients or animals.
Sally Seaver, Ph.D., President, Seaver Associates, LLC
11:30
Audience Interactive Panel Discussion with All Session Presenters
12:30
Networking Luncheon in Exhibit and Poster Hall
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