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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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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
Improving efficiency of downstream processing operations is driven by innovations that bring novel material science platforms. This presentation discusses development of salt tolerant ligands and polymers for membrane absorber for use in bioprocess separations. Developments of such materials could make 'tandem chromatography', direct loading of CEX eluate to AEX membrane possible.
LP Raman, M.S., Manager, Marketing Development, Life Sciences Process Technologies, 3M Purification Inc.
Qualitatively the potential benefit of chemically defined manufacturing processes is widely acknowledged within the industry. Next generation chemically defined supplements offer a route to maintain high productivity levels seen with peptone supplements while gaining the advantages of a chemically defined manufacturing process. This workshop looks quantitatively at how BD Recharge™, one of these supplements may impact cost of goods.
Samuel Denby, Eng.D., Applications and Scientific Manager - EMEA, Technical Applications, BD Biosciences - Advanced Bioprocessing, Belgium
Systematic and integrated use of disposable technologies - combined with a robust mAb platform - can lead to a substantial reduction of manufacturing costs, reduced timelines and increased flexibility in clinical manufacturing. We will present the direct scale up of Cellca's high titer expression platform based on a CHO DHFR cell line from shake flask to 1000 L scale in Rentschler's new disposable manufacturing facility. The presentation links design criteria for the disposable facility to competitive advantages and limitations in current disposable manufacturing. Furthermore, it contains a comparison of costs and timelines for conventional scale up including process- and media development versus rapid scale up as presented here.
Gregor Dudziak, Vice President, USP Production, Rentschler Biotechnologie GmbH, Germany
Building on its commitment to robust biomanufacturing solutions, SAFC, in partnership with Sartorius Stedim, is exploring technology to reduce the risk of adventitious virus contamination from raw materials used in upstream manufacturing processes. Developments in technologies such as HTST, UV-c irradiation and virus-retentive filtration will be presented as a layered approach to a robust risk mitigation strategy.
Wade Nudson, Manager, Technical Applications, SAFC, a division of Sigma Aldrich
Sherri Dolan, Product Manager - Virus Clearance Technologies, Sartorius-Stedim North America
Luncheon Presentation (Space is limited)
12:15
Lothar Jacob, Ph.D., Chromatography Product Manager, EMD Millipore
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Technology Workshop (with Light Continental Breakfast)
7:15
The single-use bioreactor scale-up has been fraught with numerous pitfalls and compromises. We will present data and information on how the application of fundamental process engineering, equipment design, and material selection avoids common pitfalls and minimizes the compromises associated with current day scale-up (scale-down) activities.
Jiyoung Lee, Product Manager, Bioreactors, Xcellerex, Inc.
Concurrent Technology Workshops
12:00
Screening studies were performed on Nuvia S chromatography media to evaluate the effect of load pH and load conductivity on dynamic binding capacity (DBC). Additionally, Nuvia S was included in a cation exchange screening study that evaluated product- and process-related impurity removal. Results indicate that Nuvia S resin enables higher capacities while maintaining acceptable impurity profiles.
Omayra L. Glance, R&D Assoc II, Process Biochemistry, MedImmune LLC
Christopher D. Afdahl, Scientist, Process Biochemistry, MedImmune LLC
Among the many factors that determine the suitability of a given nutrient feed, two important considerations are, 1) the metabolic behavior of the chosen cell line and 2) the content of the initial growth medium. An approach to effectively match nutrient feeds to specific processes will be described. Various methods and tools will also be discussed and compared.
Tom Fletcher, Director, ICC, Research and Development, Irvine Scientific
Platform approaches to biotherapeutic production have been in use for several years. Here we will present the Freedom ™ platforms for stable CHO cell line development, as well as the integrated Gibco® medium and feed platforms that are an integral part of many marketed molecules. Application of these platforms for improved performance and accelerated process development success will be discussed.
Peggy Lio, Senior Process Science Fellow - Gibco® Bioproduction Services, Life Technologies
The Protein A affinity capture is the single most expensive step of mAb DSP. Novasep has introduced AbSolute®, a high velocity protein A media based on modified silica, which enables operation at up to 1000 cm/h with conventional low pressure chromatography systems, thus providing 2X to 8X productivity improvement over current agarose-based media. AbSolute® exhibits enhanced stability with up to 400 capture cycles including 100 mM NaOH CIP every 5 hours. Latest developments will be presented.
Ali Kazzaz, Technical Applications Specialist, NOVASEP
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Morning Technology Workshop (with a Light Continental Breakfast)
7:15
Buffer formulation and handling is a major challenge in industrial biopharmaceutical manufacturing. There is a drive to decrease cost, use of time, labour, space and increase flexibility. Many pharmaceutical companies are replacing traditional buffer prep with in-line dilution or conditioning. This presentation describes the different options, how they are accomplished, and demonstrates the ideal intensification of buffer preparation by four pump in-line conditioning.
Enrique N. Carredano, Ph.D., Scientist, Life Sciences-Bio Technologies-R&D, GE Healthcare, Sweden
Concurrent Technology Workshops
12:00
The unique features and performance of POROS® cation exchange and anion exchange chromatography resins for the purification of biomolecules will be discussed. The benefits of high capacity, high resolution, and salt tolerant resins, as they relate to improving downstream purification process performance and productivity, will be proposed. Applications data and process modeling will be used to demonstrate the benefits of POROS ®.
Christine Gebski, MSc., Director, POROS R&D and Applications, Life Technologies
Beyond polishing applications, membrane adsorbers have not found much acceptance for downstream purification of antibody based products. The low capacity of membrane adsorbers coupled with maximum available device sizes has limited their use. We present a case study of a high binding CEX membrane for the capture of IgG from a cell free harvest and the use of the same membrane adsorber as a downstream polishing material.
Carl W. Lawton, Ph.D., Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell
While upstream productivity has increased, downstream processing is lagging behind. The existing facilities may face issues such as more biomass and contaminants; new processes may need to be more flexible. In order to meet these challenges, new technologies and products have been developed to improve the productivity, efficiency, and flexibility of downstream processes. During this presentation, current best and future potential practices in downstream processing will be highlighted.
Yujing Yang, Ph.D., Director, Purification Technologies, Sartorius Stedim North America Inc.
A series of cell-line specific complex media supplements have been developed for enhancing performance of various biopharmaceutical production systems. These supplements are manufactured using innovative, process technology which allows for the formulation of complete and/or chemically defined animal-component free media additives into a single homogenized functional supplement.
James F. Babcock, Ph.D., Global Cell Culture Applications Manager, Sheffield Bio-Science, a Kerry Group Business
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Technology Workshop (with Light Continental Breakfast)
7:15
To achieve biopharmaceutical industry levels of therapeutic recombinant proteins, SAFC has developed a new manufacturing platform process. This manufacturing platform system includes a novel CHO parental cell line as well as chemically defined medium and feeds that have been designed to work in harmony. The parental cell line is a CHO K1 glutamine synthetase (GS) knockout cell line engineered using Sigma-Aldrich's award winning CompoZr® zinc finger nuclease (ZFN) technology. Harmonized medium and feed formulations were developed using chemically defined and animal component free raw materials that have a proven track record for sourcing and robust manufacturability. The CHOZN® cell lines will be discussed, along with the subsequent CHOZN® Platform.
Kevin Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC
Concurrent Technology Workshops
11:45
"Layered beads" is a new resin design with potential to give unique functionalities and solve difficult separation problems. This presentation will show how layered beads can improve process economics and throughput in vaccine processing. Impurities such as host cell proteins and DNA fragments are eliminated in one single chromatographic step with layered beads using multimodal ligands in combination with size exclusion. Process examples of this generic process will be shown with purification of human influenza virus, as well as adeno virus.
Klas Allmér, Ph.D., Director of R&D, GE Healthcare
LFB has developed and patented a technology, the EMABling® platform, including automated steps, to allow the generation of suspensive stable clones and the production of MAbs in a chemically defined medium specifically designed for the cell line. Fed-batch process and industrial large scale production have been developed. The EMABling® platform produces EMABling® antibodies with enhanced affinity to FcgRIIIa (CD16) and high antibody-dependent cellular cytotoxicity (ADCC) activity, both related to a specific N-glycosylation pattern.
Alexandre Fontayne, Ph.D., Head of Research Unit Molecular Design, Therapeutic Innovation Department, LFB Biotechnologies
The unique benefits of using the Aber Biomass Monitor for on-line VCD and revealing additional information on the mechanisms of membrane permittivity changes as a function of cell state will be discussed. We will also demonstrate how robust models have been developed and provide an approach to harmonize any discrepancies between off-line permeability-based VCD measurements and VCD changes observed by in-line capacitance-based probes during CHO cell culture.
Rick Baggio, Ph.D., Visiting Asst Professor of Chemical Engineering, University of Massachusetts, Lowell
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