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46th Annual Symposium Sponsored by AIChE Tuesday, April 29, 2008 South San Francisco Conference Center |
The Many Facets of Biotechnology
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PROGRAM
| Time | Activity (click for Abstract and Presenter Biography) | Presenter |
| 7:30 am | Registration and Breakfast | |
| 8:50 am | Chairperson's Opening Remarks | Jean Bender, Genentech |
| 9:00 am | A Facility Expansion which Delivers Capacity and Flexibility | Dr. Alison Moore, Amgen |
| 9:40 am | Understanding the Technology Transfer Lifecycle (View Presentation) | Michelle Mostajo Chen, Genentech |
| 10:20 am | Exhibits/Break | For a list of all the exhibitors, cick here |
| 10:50 am | A Risk Assessment Lifecycle Model for Biopharmaceutical Products (View Presentation) | Dr. Scott Probst, Bayer |
| 11:30 am | Developing a Cell Culture Based Influenza Vaccine Process | Dr. Richard Schwartz, MedImmune |
| 12:10 am |
Luncheon KEYNOTE: Monoclonal Antibodies at a Crossroads (View Presentation) |
Dr. Brian Kelley, Genentech |
| 1:30 pm | Exhibits/Break | For a list of all the exhibitors, cick here |
| 2:00 pm | Challenges in Developing Multiplexed Asssays for the Quantitation of Protiein Biomarkers | Dr. Bruce Phelps, Aviir |
| 2:40 am | Continuous Improvement: Late-Stage Development of Biopharmaceuticals (View Presentation) | Dr. John Henstrand, BioMarin |
| 3:20 pm | Exhibits/Break | For a list of all the exhibitors, cick here |
| 3:50 am | Combination Product Opportunities and Challenges - A Case Study: The Macroflux Technology | Dr. Gregory Yedinak, Zosano Pharma |
| 4:30 am | Chairperson's Closing Remarks and Update on AIChE | Jean Bender, Genentech |
A Facility Expansion which Delivers Capacity and Flexibility
Alison Moore
Vice President and Fremont Site Head
Amgen Inc.
Biography
Alison Moore is Vice President and Site Head of the Amgen Inc. site in Fremont, California. She is responsible for the general management of a GMP-licensed biotechnology production facility, capable of manufacturing both bulk drug substance and drug product. Currently the facility manufactures Vectibix, the first commercial fully human monoclonal antibody, a treatment for colorectal cancer.
Prior to becoming the head of the Fremont site, Alison served as Director of CMC Regulatory Affairs at Genentech. From 1996 to 2005, Alison performed several roles in Amgen's Process Development group in Thousand Oaks, California. As Director, Bulk Protein Process Development at Amgen, Alison directed clinical and commercial process development and manufacturing support activities. Functionality included upstream and downstream development, GMP cell banking, 2KL pilot plant activities, and process engineering.
Alison holds a Ph.D. in Cell Biology from Manchester University, England and a B.Sc. in Pharmacology with Honors from Manchester University, England. She served as a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany and at Genentech, Inc.
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Understanding the Technology Transfer Lifecycle
Michelle Mostajo Chen, MBT
Engineer II
Genentech, Inc.
Abstract
The interaction among technical, compliance, and logistical factors often dictates the complexity of the technology transfer lifecycle. An evaluation of recent internal and external large-scale biopharmaceutical manufacturing projects indicates the technology transfer lifecycle can be categorized into characteristic phases. Understanding the individual phases will inherently increase the likelihood of success. Key challenges and lessons learned will be discussed.
Biography
Michelle Chen is an Engineer in the Late Stage Purification Department at Genentech, Inc. in South San Francisco. She is currently responsible for transferring recovery and purification processes for clinical and marketed products to internal and external manufacturing facilities. Michelle received her BS in Chemical/Biochemical Engineering from the University of California, Davis and an MS in Biotechnology from
San José State University. She joined Genentech in 2002 fulfilling a manufacturing support role. Prior to Genentech, she was employed at Zyomyx, Inc., a start-up biotechnology company, focusing on the development of proteomic and genomic microarray platforms.
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KEYNOTE: Monoclonal Antibody Purification at a Crossroads
Abstract
Biography
Brian obtained his B.S. in Chemical Engineering from the UW-Madison, and his Ph.D. from MIT. From 1992 to 2007, he served on the faculty of the Chemical & Biological Engineering department at Tufts University, taught graduate classes on Principles of Cell and Microbe Cultivation, and Protein Purification, and co-advised several graduate students. Brian has recently joined the PDA Biotechnology Advisory Board and is the current Chair of the Recovery of Biological Products Board.
Outside of work, Brian and his wife Debra enjoy birding, biking, hiking, and travel. He hails from rural Wisconsin, where the summers are hotter, the winters are colder, and growing up on a dairy farm was pretty much the norm.
Continuous Improvement: Late-Stage Development of Biopharmaceuticals
Abstract
Biography
A Risk Assessment Lifecycle Model for Biopharmaceutical Products
Abstract
Illustrative examples of design-phase risk assessments are presented, as well as how risk assessments are used to support on-going commercial operations. Resources and training required to support this approach are also presented.
Biography
Scott has a Ph.D. in Chemical Engineering from Carnegie Mellon University. His thesis involved employing algorithmic methods to discover faults in process systems. He has a BS in Chemical Engineering from Penn State University.
Developing a Cell Culture Based Influenza Vaccine Process
Abstract
Biography
Dick obtained his B.S. degree from the University of Michigan in 1981 and then returned to the University of Michigan in 1986 to obtain his M.S and Ph.D in Chemical Engineering. He has numerous patents in stem cell expansion, stem cell purification and vaccine production to his credit.
Challenges in Developing Multiplexed Assays for the Quantitation of Protein Biomarkers
Abstract
Biography
Prior to joining Aviir in 2006, Dr. Phelps was employed for 10 years by Chiron Corporation, where he held the position of Vice President, Research & Development, in the Blood Testing Division. As Vice President, he managed the Chiron R&D portfolios for the Ortho/Chiron Joint Venture, the Gen-Probe/Chiron Alliance and internal Blood Testing projects. He was also responsible for the manufacturing/operations group of the Ortho/Chiron Joint Venture that produces the world's supply of HCV recombinant antigens. Prior to joining Chiron, Dr. Phelps spent 13 years at Abbott Laboratories where he held various positions in Technical Product Development and R&D in the Physiologic Diagnostics and Hepatitis/Retrovirus Business Units of the Abbott Diagnostics Division. He contributed to several instrument system and assay development projects including IMx, PRISM and AxSYM.
Before transitioning to industry, Dr. Phelps held a Senior Staff Fellow position at the NIMH, studying various aspects of the biochemistry of schizophrenia at St. Elizabeth's Hospital in Washington, D.C. Dr. Phelps holds a Ph.D. in Biochemistry from Indiana University, School of Medicine and a B.S. degree in Chemistry from Clarkson University.
Combination Product Opportunities and Challenges: A Case Study- The Macroflux Technology
Abstract
Biography
Brian Kelley, PhD.
Senior Director, Late Stage Bioprocess Development
Genentech, Inc.
Process development groups defining purification processes for therapeutic monoclonal antibodies are finding themselves at a crossroads. High titer feedstocks have challenged processes and facilities to recover single batches in excess of 25 kg, and triggered debates regarding the future direction of mAb purification. Are novel unit operations required to handle these high productivity processes in a cost-effective manner, or will the new generation of resins and membranes be sufficient? An analysis factoring in process intensification, past and future trends, economics and cost of goods, facility fit issues, and pressures to conform to a platform process will be presented.
Prior to joining Genentech in 2007, Brian headed purification process development at Wyeth BioPharma in Andover, MA. This group was responsible for development, validation, and technology transfer of recovery, chromatography and filtration unit operations used for recombinant protein production from both mammalian and bacterial hosts. Brian's past technical pursuits included applying Design of Experiments and other statistical methods to process development, development of novel affinity chromatography ligands, high throughput chromatographic development, and assessment of facility fit & process intensification.
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John M. Henstrand, Ph.D.,
Senior Scientist, Manufacturing Sciences
BioMarin Pharmaceutical Inc.
During the progression from a start-up to commercial manufacturer of recombinant protein therapeutics, the focus for both cell culture and downstream purification teams has evolved. A "rush to market" phase is replaced by a "process understanding" phase, where improved control and reduced process variability are chief goals. As a consequence, Manufacturing Sciences was specifically established at BioMarin as a late-stage development group to address challenges with scale-up and commercial production, as well as troubleshoot issues that arise over time due to variability in raw materials and process performance. Manufacturing Sciences seeks continuous process improvement, using a risk-based approach for targeted studies. Key to this approach is the development and implementation of new monitoring tools as well as to fully exploit historical data and trends to study critical process parameters at the highest resolution possible. Predictive scaled-down or computer models are then used to map the space, defining acceptable ranges and optimal operational conditions. In addition, capabilities within the group exist to run confirmatory experiments at full scale. Studies utilizing computational fluid dynamics (CFD) modeling, process-specific resin customization as well as a model system for understanding column bed integrity failure will be presented.
Dr. Henstrand earned his Ph.D. from Purdue University, where he focused on aspects of aromatic amino acid pathway regulation and expression in plants. Prior to industry he pursued research at the Swiss Federal Institute Technology working on protein expression systems, purification and characterization of plant and fungal aromatic acid pathway enzymes. He joined BioMarin in 1998 as a process scientist whose responsibilities included the development and technology transfer of chromatographic and crossflow filtration processes to the manufacturing of clinical and, eventually, commercial protein therapeutics derived from mammalian cell culture. In 2002, he moved to Arriva Pharmaceuticals where he gained experience with yeast-based production systems. While at Arriva, he directed the process development laboratory and managed transfer and scale-up of downstream processes to contract manufacturers. He returned in 2006 to BioMarin to lead the downstream group within Manufacturing Sciences, where his responsibilities include the monitoring and characterization of existing commercial processes, development and implementation of process improvements as well as performing regulatory support functions.
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Scott Probst, PhD.
Process Engineering Consultant
Bayer HealthCare, LLC
This presentation describes Bayer HealthCare's model for supporting risk-based decision making from the design of a new biopharmaceutical process through the end of a product's commercial lifecycle. Initially, risk assessment is used as a design tool to check the efficacy of planned measures and to identify additional design elements to reduce product quality and business risks. During construction, the assessment is revisited to establish the process risk profile given the measures that have been implemented and to focus the qualification and validation efforts. Finally, the risk assessments are turned over to manufacturing and maintained as living documents. They support day-to-day decision making and help to prioritize process improvement projects.
Scott Probst has worked as a process engineer for Bayer Corporation for eleven years, nine of which have been in the biopharmaceutical industry. Scott has been a lead process engineer on capital projects, and he has experience bridging the gap between development and commercial operations (i.e. technology transfer). He has also been involved in several process improvement and process mapping projects, and he has led numerous GMP risk assessments, both for existing and planned processes. His experiences with risk assessments, both positive and negative, inform this presentation.
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Richard M. Schwartz, PhD.
Senior Director, Process and Manufacturing Sciences
MedImmune
Currently, influenza vaccines world-wide are produced in embryonated chicken egg which has several production drawbacks. Cell culture-based production technology promises shorter production cycles, greater surge capacity, highly controlled processes, as well as reliable and well characterized production hosts. Cell culture based manufacturing has been considered the new direction for influenza vaccine production and has been investigated extensively by several vaccine manufacturers in recent years. Similar to seasonal influenza virus strains, pandemic influenza vaccine strains can also propagate in selected mammalian and avian cells and can potentially be produced in susceptible cell lines. However, seasonal influenza vaccines consist of three different seasonal strains which are selected each season based on the circulating influenza strains. Hence, one of our challenges is to develop a robust cell culture based platform process that will require only minimal process changes for any new seasonal virus strain and for future unknown pandemic influenza viruses. This presentation highlights our systematic analysis of process variables as a way to ensure the success of future commercial supply of yet unknown seasonal and pandemic vaccine strains.
Prior to joining MedImmune, Dick was head of stem cell expansion development and then stem cell selection device development at SyStemix, Inc in Palo Alto, CA. He was responsible for development of new hematopoietic cell (CD34+) selection devices for human therapy. Prior to SyStemix, Dick worked at Aastrom Biosciences, Ann Arbor, MI and Eli Lilly, Indianapolis, IN. Dick currently leads the vaccine development efforts at MedImmune, including cell culture, purification and formulation development as well as the vaccine clinical manufacturing activities in Santa Clara, CA.
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Bruce H. Phelps
Chief Technology Officer
Aviir, Inc.
Developing a sensitive, robust assay to measure the concentration of a single protein biomarker is difficult in its own right. When assay reagents must be coupled together to measure the concentrations of several unique proteins in a single assay, the complexity increases exponentially. Guidelines for establishing target and minimally acceptable performance parameters for individual biomarkers will be discussed. Methods for evaluating and characterizing appropriate antibody binding pairs will be described. A brief review of platform technologies currently available for conducting multiplexed protein assays will be presented. As an example, typical study designs and experimental protocols for optimizing Luminex xMAP multiplexed assay reagents will be described. Finally, the elements of successful assay verification and validation testing protocols will be examined.
Dr. Bruce Phelps is currently Chief Technology Officer at Aviir, Inc., a proteomics company whose goal is to develop Personalized Medicine products that will quantitate circulating protein biomarkers. The resulting protein profiles are correlated to active disease processes such as cardiovascular disease and insulin resistance.
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Dr. Gregory Yedinak
Vice President of Operations
Zosano Pharma
Combining therapeutic products with unique delivery systems is becoming more prevalent in the Biopharmaceutical industry. Zosano Pharma has developed a transdermal microprojection delivery system which provides unique benefits including convenient needle-free administration with room temperature stability for various peptides, proteins, small molecules and vaccines. Greg will provide an overview of Zosano's Macroflux technology and a perspective on the opportunities and challenges that may be encountered bringing a combination product to commercialization.
Greg Yedinak is currently Vice president of Operations at Zosano Pharma. Prior to joining Zosano, Greg spent 15 years in various operations roles at Genentech before more recently holding Vice President positions at Abgenix (Amgen) and Nuvelo.
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