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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Technology Workshops
Technology Workshops
- 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
Concurrent Technology Workshops
11:45
The contribution of protein hydrolysates to the performance of a biopharmaceutical production system is largely medium dependent. The improper application of hydrolysates during medium optimization may result in decreased system performance and/or increased system variability. This medium dependence will be discussed, along with key elements of a suggested hydrolysate screening protocol that will help ensure effective evaluation of a supplementation scheme's overall contribution to system performance.
J.F. Babcock, Ph.D., Cell Culture Applications Manager, Sheffield Bio-Science
Transient transfection allows researchers to bridge the development bottleneck and shorten the time to usable protein. CHO suspension cells are used for stable protein expression, despite being refractory to commonly used transfection methods (e.g. linear PEI). Mirus Bio has developed a more effective alternative, the TransIT®-PRO transfection reagent. Maximum transient expression is achieved through optimization of cell density, DNA concentration, quantity of transfection reagent, and media formulation.
Laura Juckem, Ph.D., R&D Senior Scientist, Mirus Bio
Novasep's new high performance low to medium pressure Prochrom® columns are made especially for biochromatography. The combination of a moving piston and valves with an automated packing unit makes their design special and allows various modes of efficient, effortless and fast "in place" packing. More particularly, "flow packing" and "dynamic axial compression packing" will be presented for a polymer-based media. Efficiency measurements and scale-up strategies will also be illustrated for these two packing modes.
Jin Seok Hur, Ph.D., R&D Manager, Novasep, Inc.
Jason Spacek, M.S., Biopharmaceuticals Business Manager, Novasep, Inc.
Luncheon Presentation
12:15
As the demands and challenges associated with the purification of therapeutic proteins increase, new tools are needed. In this talk, the development of three chromatography media to enable improved process flexibility in terms of plant fit and buffer requirements will be described. Efforts to develop a flexible three step monoclonal antibody purification involving minimal buffer changes/dilution between process steps will be discussed. Optimization of a process using Protein A affinity capture directly eluted onto a cation exchange column followed by elution and direct loading of an anion exchange membrane adsorber will be used to describe the process flexibility benefits of these new purification tools.
Richard Pearce, Program Director - Purification Solutions, Millipore Corporation
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Technology Workshop (Light Continental Breakfast will be served.)
7:15
SAFC Biosciences raw materials characterization initiative was established to evaluate variability in raw materials used to formulate cell culture media and thereby improve media consistency and performance in cell culture manufacturing processes. Cell-based biological assays were developed to investigate the effects of raw materials on cell growth, production and product quality. Biological assays were designed to include appropriate indicator cell lines, assay media and conditions to detect lot-to-lot variability among raw material suppliers
Andrew Christie, Principal Scientist, Cell Sciences & Development, SAFC Biosciences
Concurrent Technology Workshops
12:00
Achieving Reproducible Manufacturing Outcomes through the Use of Scale-down Models
The use of accurate scale down modeling ensures that lab data represent the manufacturing case when transferring bioprocesses between sites. Diosynth has used a lab scale fermentation model to accurately reflect manufacturing operations, leading to successful scaling of five microbial processes over the last two years. Discussion will center upon how and when to use scale-down models to achieve reliable manufacturing results.
Raghu Shivappa, Ph.D., Fermentation Team Leader, Upstream Process Development, Diosynth Biotechnology
Stewart McNaull, Ph.D., Section Leader, Upstream Process Development, Diosynth Biotechnology
Raghu Shivappa, Ph.D., Fermentation Team Leader, Upstream Process Development, Diosynth Biotechnology
Stewart McNaull, Ph.D., Section Leader, Upstream Process Development, Diosynth Biotechnology
A step-by-step review of a typical mAb platform process from inoculation to final filtration will provide solutions for single- or campaign-use technology as well as technical and economical criteria to decide what the best alternative would be: a classic equipment setup or the disposable option.
Jonathan Royce, Category Leader Bioprocess, GE Healthcare Life Sciences
Part 1: Dr. Carl Lawton will present his recent work on scaling up purification of E. coli expressed proteins using single step capture and clarification.
Carl W. Lawton, Ph.D., Associate Professor, Biological Engineering Program Coordinator, Director, Massachusetts BioManufacturing Center (MBMC)
Part 2: Novel Chemistries for High-Capacity / High-Throughput Single-Use Membrane Chromatography
C Howie Honeyman, Ph.D., Vice President, Research and Product Development, Natrix Separations Inc.
The CelliGen BLU is New Brunswick's newest offering in the benchtop bioreactor and fermentor family of products. Positioned as a novel system offering 5.0L or 14.0L stirred tank single-use vessels; this system mimics traditional autoclavable technology while providing all the benefits of disposable technology. The CelliGen BLU will meet the demands of the single-use system users not satisfied with the current bench scale single-use bioreactors available on the market.
Richard Mirro, Product Manager, New Brunswick Scientific
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Technology Workshop (Light Continental Breakfast will be served.)
7:15
This workshop discusses the approach BD Biosciences-Advanced Bioprocessing is taking to address this question.
Michael J. Titus, Ph.D., Director, Quality Management & Regulatory Compliance, BD Biosciences -Advanced Processing
Concurrent Technology Workshops
12:00
This workshop will explore the use of single-use depth filtration technology and its implementation in cell clarification, primarily as a tool to replace conventional centrifuges. Encapsulated Zeta Plus disposable depth filters represent the latest product innovation from 3M Purification Inc. and its features and benefits will be highlighted during this session.
Thomas P. O'Brien, Ph.D., Senior Scientific Applications Support Specialist, 3M Purification Inc.
Results from a collaborative program between Irvine Scientific, CA., USA and Selexis, S.A., Geneva, Switzerland will be presented.
Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific
Pierre-Alain Girod, Ph.D., Chief Scientific Officer, R&D, Selexis SA, Switzerland
High cell densities and product yields require culture media and feeds formulated so that no one nutritional component becomes limiting. Integration of the basal medium and feed design ensures nutrient availability. IgG titers of 2.6 g/L were reached using an integrated design strategy compared with starting titers of 0.5 g/L. This represents a 10-fold improvement over batch culture. Potential challenges and solutions will be discussed.
Shawn Barrett, Senior Manager, R&D, Invitrogen, part of Life Technologies
The features and performance of POROS® XS chromatography resin will be highlighted. The benefits of a high capacity, high resolution, salt tolerant CEX resin as they relate to improving downstream purification process performance and productivity will be proposed. Applications data and process productivity modeling will be used to demonstrate the benefits of utilizing POROS XS.
Christine Gebski, M.S., Director, POROS Applications and R&D, Applied Biosystems, part of Life Technologies
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Technology Workshops
12:15
The current requirement for the biomanufacturing industry is to shorten the time taken to deliver new drugs to the market and reduce overall costs while maintaining regulatory compliance and product quality. During this workshop, Novozymes will discuss how the introduction of innovative technologies and products, such as recombinant protein solutions, and ongoing collaborative dialogue with the manufacturer is helping to drive efficiency improvements across the product lifecycle.
Sally Grosvenor, Ph.D., Senior Scientist and Scientifict Communications Manager, Applied R&D, Novozymes Biopharma
This case study details how a leading protein processing facility, Diosynth Biotechnology, implemented microvolume UV-Vis testing at critical points in the workflow to greatly reduce processing time and increase efficiency. NanoDrop microvolume UV-Vis spectrophotometers are simple tools which can be easily implemented throughout a processing organization including R&D, manufacturing and quality control with great impact on the entire workflow and on debottlenecking steps.
Philippe Desjardins, Scientific Marketing Manager, Thermo Scientific NanoDrop Products
The consistent and integrated use of disposable technologies enables a fast and reproducible GMP manufacturing and allows a substantial cost cutting for clinical supply. A comparative study on commercially available single-use technologies will be presented providing an in-depth cost comparison with conventional non-disposable facilities. Data from different stirred single-use bioreactor systems regarding operability and process kinetics at 250-L scale will be supplied as well as cell separation capacities assigned for using as disposable state-of-the-art filtration units. The integration of disposable downstream technologies will be discussed.
Dethardt Müller, Ph.D., Rentschler Biotechnologie GmbH, Germany
Gregor Dudziak, Ph.D., Vice President, Cell Culture, Rentschler Biotechnologie GmbH, Germany
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