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View Sub-Track: Single-Use Technology
Wednesday, March 26, 2008
BIO-5: Major Benefits of Single Use Systems in the Biopharmaceutical Industry 9:00AM - 10:00AM (Wednesday, March 26, 2008)
The evolution of single use bioprocess technology in the biopharmaceutical Industry has resulted to be a major asset for the cell cultivating fermentation, fluid processing and fluid delivery industries. The major benefits of single use systems are: • Equipment cost reduction • Facility cost reduction • Commissions and validation cost reduction Operational efficiencies will be improved by reducing equipment assembling and disassembling time. Additionally, they will result in reducing the following utility systems: • cleaning and CIP usage • clean steam (SIP) and autoclave usage • WFI and compressed air usage • Liquid waste generation
Ahmad Shahidi - Senior Technical Consultant, Parsons
BIO-6: Implementation of a Disposable, Single Use, Scalable, Mixing System for Buffer Preparation in a Multipurpose Biopharmaceutical Environment 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Traditional stainless steel mixing systems used in biopharmaceutical processing applications require a considerable time be allowed for cleaning, sterilization and validation following a mixing run. With increasing pressure within the industry to both reduce fixed costs, and maximize operational facility time, reducing the time required for these actions is becoming a high priority. At the facility in question we sought to implement disposable systems for buffer preparation to both reduce these direct and indirect costs, but to also increase manufacturing flexibility. This is important both for the implementation of new projects, but especially for contract manufacturing activities. A new non-invasive, single use, disposable, liquid/liquid and liquid/powder mixing system was evaluated that potentially circumvents these time consuming and costly steps. In part 1 of the experimental program the mixing system was tested to determine its suitability for use for the scalable and homogeneous mixing of sodium chloride which was selected as a typical buffer system. In part 2, the design of the disposable component of the system was reviewed, suggestions were made to the manufacturer to optimize both design and functionality, further evaluation of the modified disposables were undertaken, and the systems compatibility for use in a cGMP environment was investigated.
Derek Pendlebury - Director Sales and Marketing, ATMI LifeSciences
BIO-7: WORKSHOP: The Complete, Single-Use Biopharmaceutical Process: If or When? 2:00PM - 3:30PM (Wednesday, March 26, 2008)
Presented By:
Single-use technologies are gaining increasing acceptance for biopharmaceutical processing. As the application of disposable technologies has expanded from its earliest applications in filtration to other uses such as cell culture, bioprocess containers, connection devices, and transfer lines, the question is raised of whether it is possible, now or in the future, to have a fully disposable biopharmaceutical manufacturing process. Three industry speakers will present their experiences implementing disposable technologies, including advantages and disadvantages, implementation challenges and limitations, where the greatest barrier may lie (e.g., sensors, chromatographic separations), and whether a fully disposable process is in even desirable. Following the presentations, the speakers will join Laura Bush, Editor in Chief of BioPharm International, in a panel discussion of the issue, including an interactive conversation with the audience.
Moderator:
Laura Bush - Editor in Chief, BioPharm International
Speaker:
Geoffrey Hodge - VP Process Development and Technology, Xcellerex, Inc.
Peter Watler, PhD - Vice President, West Coast Operations, JM Hyde Consulting, Inc.
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