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View Track: Biotechnology
Biotechnology
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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-1: Diagnostic Reagent Facility Expansion--A Case Study 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Siemens Medical Solutions Diagnostics (Formerly Bayer Healthcare, Diagnostic Divsion) and Jacobs have been working together on a project to expand their existing facility in Walpole, MA. The prime driver for this project was the extremely robust growth in the Immunodiagnostics business. This growth, which is expected to continue unabated, is expected to continue over next several years. As a result significant additional capacity is needed in order to be able to service the growing marketplace. The expansion effort has been approached by Siemens, in an extremely logical manner. The first step was to establish the maximum manufacturing capacity of the existing facility and when additional capacity should be brought on line to ensure continuity of supply to their customers. This was done by developing both a demand forecast and a highly complex dynamic capacity model of the existing manufacturing facility. From the modeling exercise a variety of business options were evaluated and the management team elected the Walpole facility expansion option. This case study will present a complete story of development and delivery of this fast track project in a step wise fashion beginning with conceptual design, preliminary engineering, project capital appropriation, and going on to detailed design and construction. This presentation will provide insight into prime project implementation issues encountered and how a partnership between the local authorities, the Siemens integrated execution team, which includes the key service providers of Engineering, Procurement, Construction Management and Commissioning/Qualification services is leading to the completion of a state of the art model project.
Michael Canary - Director of Engineering, Siemens Medical Solutions Diagnostics
BIO-2: Bioreactor Specification 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This presentation will provide instruction and points to consider for scope definition, equipment specification and procurement of pilot & production scale bioreactor systems. The session will focus on elements of equipment specification that are unique to cell culture and fermentation processes - requirements for axenic processing, CIP/SIP, single-use components, bioreactor instrumentation, vessel agitators, feed systems, sampling, media filtration, perfusion and recovery.
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-3: Critical Factors in Mimic Brand Product Formulation for Drug R&D 2:00PM - 3:00PM (Wednesday, March 26, 2008)
In this highly competitive generic drug business, the key to be the winner in the market is to have products delivered to the pipeline continuously in a cGMP facility. However, the actual situation is that the generic drug formulation which can pass bioequivalent (BE) requirements is only about 40% to date on average. Therefore, it is very critical to have the right tools and knowledge in developing the successful formulation to be able to compete with market. In this presentation, we would like to start with the concept of “in-vitro to in-vivo” simulation based on Fraction Dose Absorbed. It is a mathematical model which describes the factors determining the drug absorption. With this proven successful model in drugs absorption, we will then discuss the correlation of these critical factors to the drug formulation development. These critical factors to be discussed including: particle size, active-excipients compatibility, drug pH, stability, GI tract hydrodynamics and pH variation, transient concentration, BE approaching and dissolution, BE study, and finally formulation processes. With these critical factors considered in the drug development, one should be confident in obtaining a BE formulation to mimic brand products, and therefore be able to compete with market.
Joe Chou, PhD - Vice President, Pharmtel Corporation
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.
BIO-4: Design Alternatives for Multi Product Cell Culture Facilities 3:15PM - 4:15PM (Wednesday, March 26, 2008)
Designing a multi product cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of larger scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in a modern call culture facility.
Klaus Hermansen - Senior Specialist, Consulting, nnepharmaplan
Thursday, March 27, 2008
BIO-8: WORKSHOP: Aseptic Processing and Manufacturing: From Compliance to Contamination to Control 9:00AM - 11:00AM (Thursday, March 27, 2008)
This session will cover a spectrum of issues related to aseptic processing and manufacturing. Dr. Vadheim will give an overview of regulatory and compliance guidelines as well as point to a scientific overview of critical issues pertaining to aseptic processing manufacturing. Dr. Ashtekar will focus primarily on success stories around the manufacturing of bacterial and viral derived vaccines as well as discuss potential microbial incursions into the manufacturing process. Dr. Sidhu will present case studies linking contamination issues to the aseptic environment as well as solutions for such. Mr. Guardino will focus on the latter as far as disinfectant challenge efficacy and case studies where manufacturing shutdowns have been resolved through the most effective disinfectant/sanitization challenge.
Moderator:
Jaspreet Sidhu, PhD - VP, Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. (MEI)
Speaker:
Dilip Ashtekar, PhD - Chief Microbiologist for Operations and Director, Global Microbiology, Amgen
BIO-11: Drug Delivery of Biopharmaceuticals - What is Important for an Efficient Combination of Biologic, Pre-filled Syringe and Autoinjector? 10:15AM - 11:15AM (Thursday, March 27, 2008)
Injection is the most common route of administration for biopharmaceuticals. Product launches with pre-filled syringe systems facilitate life cycle strategies and improve patient convenience. As self-injection is increasing, biopharmaceutical companies go one step further and introduce their products with syringe-based autoinjectors. This means more components, more interfaces and higher complexity of the drug delivery system. How can these challenges be addressed in development projects? Key requirements are arising from the interfaces between biopharmaceutical, pre-filled syringe and autoinjector device. Highlighted in this presentation are - principles to select optimal syringe systems and autoinjector devices according to biopharmaceutical product and therapeutic class, - strategies to reduce interactions of biological molecules with leachables and silicone lubricant from pre-filled syringe systems (drug / device interface) and - technologies to establish syringe dimensions, break-out and gliding forces which are compatible with autoinjector specifications (device / device interface). The session points out which action items need to be agreed at an early stage of development between biopharmaceutical company, syringe supplier and autoinjector producer to lay out the road map for a successful product launch.
Speaker:
Arno Fries, PhD - Head of Sales North America, Gerresheimer Buende GmbH
BIO-12: Economics of Vaccine Production Using Virus-Like Particles 2:00PM - 3:00PM (Thursday, March 27, 2008)
Virus-like particles (VLPs) made by recombinant techniques using single use disposable equipment offer significant advantages over the traditional vaccine manufacturing approach. This manufacturing method results in lower capital and operating cost and greatly reduced time to market. This presentation provides an overview of the VLP manufacturing process and describes what a commercial facility might look like. Capital and operating costs are estimated and compared to conventional vaccine manufacturing processes. An update on the status of this developing technology is also provided.
Speaker:
Robert Bader - Sr Mgr Technology Pharmabio, Jacobs Engineering
James Robinson - Vice President of Preclinical and Quality Operations, Novavax, Inc.
BIO-9: The ASME-BPE Global Standard for the BioPharm Industry 2:00PM - 3:00PM (Thursday, March 27, 2008)
The session will provide an overview of the American Society of Mechanical Engineers - Bioprocess Equipment (ASME-BPE) standard and its implications for the biopharmaceutical industry. Mr. Zinkowski, who is Vice Chair of the BPE Standards Committee, will provide a brief overview of each part and structure of the BPE Standards committee, the inception & development of the standard, and the interface between the ISPE, P3A, 3A.
Speaker:
Rick Zinkowski - Vice Chair, BPE Standards Committee, American Society of Mechanical Engineers - Bioprocess Equipment
BIO-10: Shortening 'Time to Money' for BioPharma Facilities-Lessons from the Semiconductor Industry 3:15PM - 4:15PM (Thursday, March 27, 2008)
Shortening "time to money" is a critical factor for any new BioPharma facility. Important lessons can be learned from the Semiconductor Industry where the cost of new chip-making facilities range from $3.5B to $7B. Delays in production cost Chipmakers over $100M per week. Collaborative project management reduces or eliminates those delays. Shortening "Time to Money" for is a critical factor for BioPharma facilities.
BIO-13: Design Alternatives for Multi Product Vaccine Facilities 3:15PM - 4:15PM (Thursday, March 27, 2008)
Designing a multi product vaccine cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of large scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in modern vaccine facilities
