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Mark Your Calendar for 2012
October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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August 21-22, 2012
Shanghai, China
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Recovery & Purification
- 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
Recovery & Purification
8:00
Chairperson's Remarks
Rick St. John, Ph.D., Senior Engineer, Purification Development, Biologics Department, Genentech, Inc.
Rick St. John, Ph.D., Senior Engineer, Purification Development, Biologics Department, Genentech, Inc.
Streamlining Downstream Processing to Improve Cost and Time to Clinic
8:15
Fully Automated Quantitation Assays Measuring IgG Product and Residual Host Cell Proteins Using the Octet QK384 Platform
The quantitation of IgG product and residual host cell proteins (HCP) is crucial in process development for monoclonal antibody therapeutics. Integration of an Octet QK384 instrument with a Hamilton liquid handling robot allowed the creation of a fully automated IgG product quantitation assay and fully automated residual HCP assay with minimal method optimization. IgG product quantitation typically requires long overnight assays with a HPLC platform, but the fully automated IgG quantitation assay can process and analyze a full 384 well plate in approximately 2-3 hours. The residual HCP assay was developed using ForteBio's Streptavidin biosensors and a Metal DAB precipitating substrate that can be completed in approximately 2 hours. Residual HCP quantitation typically requires the use of laborious sandwich ELISAs often taking several hours to complete, whereas the fully automated HCP assay allows a scientist to run multiple 96 well assay plates in a single run without any user involvement after the initial setup.
Dan Schuessler, Analytical Scientist, GlaxoSmithKline
The quantitation of IgG product and residual host cell proteins (HCP) is crucial in process development for monoclonal antibody therapeutics. Integration of an Octet QK384 instrument with a Hamilton liquid handling robot allowed the creation of a fully automated IgG product quantitation assay and fully automated residual HCP assay with minimal method optimization. IgG product quantitation typically requires long overnight assays with a HPLC platform, but the fully automated IgG quantitation assay can process and analyze a full 384 well plate in approximately 2-3 hours. The residual HCP assay was developed using ForteBio's Streptavidin biosensors and a Metal DAB precipitating substrate that can be completed in approximately 2 hours. Residual HCP quantitation typically requires the use of laborious sandwich ELISAs often taking several hours to complete, whereas the fully automated HCP assay allows a scientist to run multiple 96 well assay plates in a single run without any user involvement after the initial setup.
Dan Schuessler, Analytical Scientist, GlaxoSmithKline
Unpublished Data
8:45
Case
Study
Development of a Simple and Semi-Continuous Monoclonal Antibody Purification ProcessStudy
A simple and semi-continuous mAb purification process was developed using only one buffer species and four buffers. The purification process includes a Protein A affinity column step, a continuous flow CEX column/AEX filtration/viral filtration step, and a UF/DF/bulk filtration step. The purification process takes only 3 days. The developed process is simple, robust, economical, and manufacturing friendly.
Guihang Zhang, Ph.D., Scientist III, Group Leader, Process Development, Agensys, inc.
Unpublished Data
9:15
Process Development and General Platform Fit of an Multimodal Anion Exchanger Following Protein A Capture
Present work outlines the development of a strong anion exchanger with multimodal functionality for the purification of monoclonal antibodies (bind and elute chromatography). An overall platform approach for implementation of this polishing step, from lab to pilot scale, will include performance across several bioproduct (antibody) examples as well the reduction of manufactured raw materials (buffers) and process productivity improvements.
William Holmes, Research Scientist, Virology and Purification Development, Eli Lilly and Company
Present work outlines the development of a strong anion exchanger with multimodal functionality for the purification of monoclonal antibodies (bind and elute chromatography). An overall platform approach for implementation of this polishing step, from lab to pilot scale, will include performance across several bioproduct (antibody) examples as well the reduction of manufactured raw materials (buffers) and process productivity improvements.
William Holmes, Research Scientist, Virology and Purification Development, Eli Lilly and Company
9:45
Networking Refreshment Break in Exhibit and Poster Hall
10:30
Case
Study
Challenges Associated with Development of a Polishing Step for a Non-Platform Monoclonal AntibodyStudy
Bio-pharmaceutical process development has been increasingly relying on HTS and platform processes for accelerating process development and reducing time to clinic. While a platform process can be applied to a majority of MAbs, certain MAbs may not fit into the platform process thus requiring further development. This talk will focus on the process development of a MAb that binds to the anion exchange resin under platform flow-through conditions.
Deepa Nadarajah, Ph.D., BioProcess Engineer, Purification Development, Genentech, Inc.
11:00
Case
Study
Ultrafiltration/Diafiltration Formulation Operation Strategies to Maximize Yield and Reduce Risk for Biopharmaceutical Drug Substances with Different Concentration/Volume RequirementsStudy
Flexible manufacturing equipment design and operations are becoming important in the biopharmaceutical industry especially in regard to the ultrafiltration/diafiltration (UF/DF) formulation unit operation. A case study will be presented showing how MedImmune adapted a manufacturing scale UF/DF system to produce a high concentration/low volume drug substance. This system was originally designed to produce a high volume/low product concentration drug substance. General guidelines for maximizing yield and minimizing facility fit risk will be presented.
Carnley Norman, Ph.D., Scientist II, MedImmune
Featured Presentation
11:30
Fitting the Glass Slipper: Process Design, Plant Capacity, and Value RealizationA good fit between plant and process is critical in assuring robust high value operations. Understanding process fit using model systems, statistical analysis of process trends, and inclusion of plant capacity and throughput constraints in Quality by Design programs can anticipate plant performance, enable control and capability, and increase value from high fixed cost assets.
Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration
12:30
Networking Luncheon & Last Chance to Visit the Exhibit and Poster Hall
Recovery & Purification
1:40
Chairperson's Remarks
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Advances in Initial Recovery - Viewing the Harvest Step as a Purification Step
1:45
PDADMAC Flocculation of CHO Cells: A Centrifuge-Less Harvest Process for mAb's
Thomas McNerney, Ph.D., Amgen Inc.
Thomas McNerney, Ph.D., Amgen Inc.
Unpublished Data
2:15
Case
Study
Acidification as a Means for Reducing Impurity Levels and Improving Throughput in Harvest OperationsStudy
Clarification of high cell density mammalian cell culture broths is typically performed with a combination of centrifugation and depth filtration steps, followed by a 0.2um filtration step. Acidification of the cell culture broth was evaluated as a means of improving filterability and hence the performance of the clarification process. This presentation describes the impact of the acidification of cell culture harvest prior to cell removal. The study demonstrated that cell culture acidification not only reduces host cell impurities, but also enables significant improvement in filtration throughput of depth and sterile filters, achieving process robustness and a reduction in filter costs. Additionally, acidification markedly improves the product clarity during the holding period between harvest clarification and capture leading to further filter cost reduction.
Linda Rich, M.S., Research Scientist, Technical Operations, Abbott Laboratories
Unpublished Data
2:45
Understanding the Harvest Operation using Dynamic Particle Sizing Technology
During harvest it is difficult to express the effectiveness of particle removal. Using a micro-CCD technology and software, a detailed analysis of particle removal was performed during a harvest process. Disc stack centrifugation and depth filtration were analyzed various time points during the process. The results identified the size and number of particles that potentially could challenge the downstream operations.
Sheldon Oppenheim, Ph.D., Senior Engineer I, Cambridge Biologics CMC Group, Millennium: The Takeda Oncology Company
During harvest it is difficult to express the effectiveness of particle removal. Using a micro-CCD technology and software, a detailed analysis of particle removal was performed during a harvest process. Disc stack centrifugation and depth filtration were analyzed various time points during the process. The results identified the size and number of particles that potentially could challenge the downstream operations.
Sheldon Oppenheim, Ph.D., Senior Engineer I, Cambridge Biologics CMC Group, Millennium: The Takeda Oncology Company
3:15
Networking Refreshment Break
Plenary Session: Innovative Principles and Integration in Upstream and Downstream Processing
Unpublished Data
3:45
Case
Study
Integrating Downstream Requirements in Upstream Processing - Optimizing Mass Throughput and Insuring Product QualityStudy
Bruno Figueroa Jr., Ph.D., Senior Principal Scientist, BioTx Pharm Sciences, Bioprocess R&D, Pfizer Inc.
4:15
Case
Study
Design of a Facility of the Future for Integrated Upstream and Downstream Processing for Fed-Batch and Perfusion ManufacturingStudy
Production Technology and Cell Biology is developing rather quickly while current Biotech Facilities once constructed and in operation are rather difficult to change. The presentation will try to address the changes seen in Biotech production and will evaluate how modern facility concepts maybe able to address ongoing and future changes.
Thomas Daszkowski, Ph.D., Vice President, Head of Process Technology BTS-A, Bayer Technology Services
Keynote Presentation
4:45
The Impact of Antibody Drug Conjugates on Process Development and ManufacturingThe antibody-drug conjugate (ADC) concept is to use an antibody to deliver a cytotoxic drug selectively to a target such as a tumor-associated antigen. Such conjugates represent a broadly applicable approach to enhance the antitumor activity of antibodies and improve the tumor-to-normal tissue selectivity of chemotherapy. There is a rapidly growing number of ADC's moving through clinical development towards the marketplace. This talk will review the ADC field and focus on some of the unique challenges and opportunities from a process development and manufacturing perspective.
Morris Rosenberg, Ph.D., Executive Vice President, Process Sciences, Seattle Genetics
5:30
Close of Day Three
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Recovery & Purification
8:00
Chairperson's Remarks
David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc.
David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc.
Overcoming the Bottlenecks in Downstream Processing
8:15
Approaches to Overcome Operational Bottlenecks in Antibody Manufacture
Natraj Ram, Ph.D., Senior Group Leader, Manufacturing Sciences, Abbott Bioresearch Center
Natraj Ram, Ph.D., Senior Group Leader, Manufacturing Sciences, Abbott Bioresearch Center
Unpublished Data
8:45
Case
Study
Design and Installation of an In-Line Formulation Buffer Systems for Large-Scale Biologics Manufacture ProcessesStudy
A typical downstream purification process for large-scale biologics manufacture usually requires large quantities of buffer, representing a preparation, storage, and logistics challenge. At MSD an automated in-line formulation buffer system for flexible operations and ability to respond to changes in program schedules has been built that can distribute ready-to-use buffers to the processing suites.
Matt Kessler, M.S., Research Associate Engineer, Merck Sharp and Dhome
9:15
Overcoming Downstream Purification Challenges in Executing Modern High Titer Processes in Legacy Manufacturing Plants
Legacy Cell culture manufacturing plants face increasing challenges in handling modern cell culture processes with titers exceeding > 2.5 g/L. The problems faced particulary in downstream purification, the range of potential solutions that can be implemented together with recent case studies of high titer processes executed at one of the legacy Lonza facility will be presented during this talk.
Rajesh G. Beri, Ph.D., Director, Manufacturing Sciences & Technology, Lonza Biologics
Legacy Cell culture manufacturing plants face increasing challenges in handling modern cell culture processes with titers exceeding > 2.5 g/L. The problems faced particulary in downstream purification, the range of potential solutions that can be implemented together with recent case studies of high titer processes executed at one of the legacy Lonza facility will be presented during this talk.
Rajesh G. Beri, Ph.D., Director, Manufacturing Sciences & Technology, Lonza Biologics
9:45
Networking Refreshment Break
Use of Monitoring and High-Throughput Methods in Downstream Process Development
Unpublished Data
10:15
Case
Study
High-Throughput AnalyticsStudy
This presentation will describe several approaches to increase throughput of protein analysis. These methods can serve as at-line analytics when performing HTE as well as in- or at-line analytics for process monitoring. By combining interlaced injection with parallelization of two sec columns, both lag time before and after the peaks of interest could be eliminated. In the setup, a new type of sec columns with smaller particle size and the capability of withstanding larger backpressures was applied. Thus, while determined aggregate levels and reproducibility were equal to single injections, assay time could be reduced to less than two minutes using the parallelized interlaced mode. I a second approach, PLS regression was used to correlate selective protein concentrations to protein absorption spectra. On the basis of this non-invasive and label-free methodology, a fast and precise analytical assay was established. The assay is easily automated and can be performed in well-plate-format. Further, the assay can be used for in-line process monitoring of chromatographic protein separations.
Jürgen Hubbuch, Ph.D., Professor of Biomolecular Separation Engineering, Karlsruhe Institute of Technology, Germany
Unpublished Data
11:15
High-Throughput Screening Methodologies and Applications in Downstream Process Development
Mei Huei Jang, Ph.D., Senior Scientist, Purification Process Development, Shire Pharmaceuticals
Mei Huei Jang, Ph.D., Senior Scientist, Purification Process Development, Shire Pharmaceuticals
11:15
Application of QbD and PAT Methods to an E. coli Protein Purification Process Development Project
Quality by Design (QbD) and Process Analytical Technology (PAT) are receiving a lot of attention in biopharmaceutical and biotechnological industries subsequent to the regulatory guideline. Biopharmaceuticals are complex, which translates into complex manufacturing processes. QbD, when properly applied during process development, yields a process map to get from raw material to finished product. PAT can potentially act as a guide, e.g., like a GPS, to successfully reach the destination (final drug substance manufacturing process). These methods were utilized to accelerate the downstream process development of an E. coli protein. The paper discusses the implementation in downstream process development during tangential flow filtration and chromatography steps functioning to remove impurities and maximize overall recovery of active protein (drug substance) for an early stage manufacturing process.
Ji Zheng, Ph.D., Senior Scientist, Biologics Development, Allergan, Inc.
Quality by Design (QbD) and Process Analytical Technology (PAT) are receiving a lot of attention in biopharmaceutical and biotechnological industries subsequent to the regulatory guideline. Biopharmaceuticals are complex, which translates into complex manufacturing processes. QbD, when properly applied during process development, yields a process map to get from raw material to finished product. PAT can potentially act as a guide, e.g., like a GPS, to successfully reach the destination (final drug substance manufacturing process). These methods were utilized to accelerate the downstream process development of an E. coli protein. The paper discusses the implementation in downstream process development during tangential flow filtration and chromatography steps functioning to remove impurities and maximize overall recovery of active protein (drug substance) for an early stage manufacturing process.
Ji Zheng, Ph.D., Senior Scientist, Biologics Development, Allergan, Inc.
12:15
Lunch on Your Own
Recovery & Purification
1:25
Chairperson's Remarks
Sid Advant, Ph.D., Senior Director, CMC Project Management, ImClone Systems Corp.
Sid Advant, Ph.D., Senior Director, CMC Project Management, ImClone Systems Corp.
Beyond Antibodies - Downstream Processing of Next Generation and Novel Molecules
Unpublished Data
1:30
Into the Folding Future
In the presentation, current approaches of development and production procedures of such complex refolding steps will be discussed in the light of scalability and future technologies including possibilities of analytical on-line monitoring. Experiences and results of large scale refolding reactions and their development, as well as challenges of scaling up and down are evaluated in the context of nowadays requirements of process understanding and validation concepts.
Gerlind Stoller, Ph.D., Head, Downstream Process Development, Sandoz Biopharmaceuticals Technical Development, Sandoz GmbH, Austria
In the presentation, current approaches of development and production procedures of such complex refolding steps will be discussed in the light of scalability and future technologies including possibilities of analytical on-line monitoring. Experiences and results of large scale refolding reactions and their development, as well as challenges of scaling up and down are evaluated in the context of nowadays requirements of process understanding and validation concepts.
Gerlind Stoller, Ph.D., Head, Downstream Process Development, Sandoz Biopharmaceuticals Technical Development, Sandoz GmbH, Austria
2:00
Issues in the Development and Scale Up of Antibody Drug Conjugates
Michael Sun, Ph.D., Principal Scientist, Seattle Genetics
Michael Sun, Ph.D., Principal Scientist, Seattle Genetics
Unpublished Data
2:30
Case
Study
Bioconjugate Processing Challenges: Aggregation Case StudiesStudy
Although bioconjugate molecules can differ greatly in molecular weight and physical properties, common challenges are often encountered during development and optimization. One common challenge is aggregation which can occur by both covalent (chemical crosslinking) and non-covalent interactions. Examples of the challenges encountered during development for both antibody conjugates as well as therapeutic vaccines will be described.
Brandi Osborne, Ph.D., Senior Scientist, Conjugation and Polytides Process Development, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc.
3:00
Networking Refreshment Break
Process Validation and Characterization
3:30
Case
Study
Strategy for Establishing a Process Control Strategy - A Case StudyStudy
A. Graham Tulloch, Ph.D., Research Advisor, Virology & Purification Development, Eli Lilly & Company
Unpublished Data
4:00
Case
Study
Technology Transfer into a Fully Disposable Facility - Assessing Risk from Extractables and LeachablesStudy
Use of disposables in Biotech/Pharma manufacturing provide several processing advantages, over traditional stainless steel equipment, such as reduced turnaround times and validation burden in terms of cleaning and sterilization. Introduction of transfer of commercial products into facilities, that heavily utilize disposable technologies, introduce several challenges due to potential Extractables and Leachables from disposable components. This talk aims to provide the approach utilized by Shire Human Genetic Therapies to assess potential risk from individual disposable component use as well as cumulative risk to the process or product due to the use of multiple disposables. Use of quality risk assessments in combination with in-process and/or simulated testing for process clearance of potential leachables will be discussed as a means of evaluating process and product risk.
Ravi Samavedam, Associate Director, Validation, Shire Human Genetic Therapies
Kevin Pham, Senior Process Validation Engineer II, Shire Human Genetic Therapies
Unpublished Data
4:30
Risk-Based Experimental Design for Purification Process Characterization
Process characterization represents a critical and time-consuming phase of process development. Process characterization efforts must produce thorough process understanding while staying on prescribed timelines. Pre-defined tools and rational experimental design can maximize process understanding with manageable effort. This presentation will describe tools developed at Genentech for risk-based experimental design of characterization studies and will show results from a project using the described approach.
Rick St. John, Ph.D., Senior Engineer, Purification Development, Biologics Department, Genentech, Inc.
Process characterization represents a critical and time-consuming phase of process development. Process characterization efforts must produce thorough process understanding while staying on prescribed timelines. Pre-defined tools and rational experimental design can maximize process understanding with manageable effort. This presentation will describe tools developed at Genentech for risk-based experimental design of characterization studies and will show results from a project using the described approach.
Rick St. John, Ph.D., Senior Engineer, Purification Development, Biologics Department, Genentech, Inc.
5:00
Close of BPI 2011
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