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View Track: Technology Enablers
Technology Enablers
Wednesday, March 26, 2008
T-4: Anti-Counterfeiting: A Multi-Layered Approach to Detection and Prevention 9:00AM - 10:00AM (Wednesday, March 26, 2008)
General:
With 10% of worldwide pharmaceuticals counterfeit, this is a growing problem that only gets worse as criminal enterprises get more sophisticated. This session covers multi-faceted approach to tackling this problem. Many of the techniques taught here also help address gray market and diversion problems.
• The problems of counterfeiting and diversion • Multi-layered protection • Overt, Covert, Forensic approaches – e.g. Polychromatic markings, Pen or Light revealable Inks, Ingestible Authentication Markers, Nano-patterning, etc. • Field audit programs • RFID and ePedigree
Speaker:
Bill McBeath - Managing Director, Research and Advisory Service Supply Chain Risk Management, Marsh
T-1: The Role of Industrial Automation in Qualified & Non Qualified Building Automation Solutions 9:00AM - 10:00AM (Wednesday, March 26, 2008)
A paradigm shift has occurred; The building has become part of the process, and,conversely, the same equipment that manages your manufacturing process today can also manage your facility's environment. What if you could lower your cost of ownership through a more integrated approach to BAS/QBAS? By managing the environment using the same control platform as the process, you could make better use of your training budget,eliminate "locked in" long term support agreements in favor of a more flexible "Menu Selection" of support services, and improve your bottom line. In addition, validation of any system can be a challange. Regulatory compliance is not easy. But if the same approach is adopted in terms of control to the environment, as is the process, you will create an element of commonality in respect of the documentation and protocols employed. Learn more about integrating your environmental management into your production process in this session and become the master of your domain!
T-2: Benefits of Integrating Production and Quality Information 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session case study will review a successful integration of real time quality results from laboratory information systems to production systems. The case study will stress the importance of using ISA standard S88 and S95 in concert to achieve successful interoperability. Today's manufacturing execution system platforms offer an opportunity to integrate data from production and quality systems resulting in improved productivity and traceability. Genealogy tracking of production ingredients in manufacturing is a common requirement for production MES systems; however, the linkage of product data to laboratory test results is often lacking or not in real time. A key goal of any MES implementation should be to optimize laboratory operations to support production. Industry standards have emerged as guidelines to understanding how this data should be exchanged in a real time production
T-5: Results of Serialized 2D Barcoding Pilot to Support Item-Level Track & Trace 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Talk and discussion around the results and lessons learned from a serialized barcode pilot conducted with Catalent Pharma Solutions and Secure Symbology.
Speaker:
Richard Smith - Director of Engineering , SecureSymbology
John Vignola - Manager, Business Development, Catalent Pharma Solutions
T-6: What Do We Really Mean By Security for RFID -- And How Much Is Enough? 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Many pharmaceutical manufacturers and distributors are looking to RFID as a solution for protecting, authenticating and tracking their products. Critical concerns around security and privacy, including HIPAA compliance, are being raised with the growing push towards adoption of RFID technology. Many people think of securing the pharmaceutical supply chain as “encrypting” data when in fact many different security tools may be used in different combinations. The level of security that is appropriate for particular pharmaceutical applications such as anti-diversion, e-pedigree, track & trace and cold chain management will also vary and must be balanced against the apparent risks. This talk will cover the spectrum of functions that can provide security for RFID such as encryption, authentication and other data protection methods. It will also discuss how security functions can help provide privacy protection and how security and privacy differ. The latest developments in security solutions from the RFID industry will also be reviewed.
Speaker:
Louis Parks - President & CEO, SecureRF Corporation
T-3: WORKSHOP: Automation of 'Plug and Play' Process Skids and Components in a Biopharm Facility 2:00PM - 4:00PM (Wednesday, March 26, 2008)
To enhance the flexibility and usability of biopharma pilot, clinical, and production facilities, moveable and portable process skids, tanks, chromotography units, and other modular process components are employed. The integration of these components into a process control system can be challenging and difficult. With proper planning, development of detailed user requirements, and an in-depth knowledge of S88, the proper automation strategy can be developed. The author will develop the automation strategy for a "prototype" biopharm process during this session. An interactive approach will be taken with the attendees, with the goal of identifying the major considerations of defining an automation strategy for "plug and play" components.
T-7: Meet California ePedigree Law with 2D Item-Level Mass Serialized Codes and/or RFID 3:15PM - 4:15PM (Wednesday, March 26, 2008)
The California ePedigree Law is set to go into effect January 1, 2009 with major wholesalers expecting an ePedigree solution in place by July 2008 to fill the supply chain. With a fixed date, supported by penalties for non-compliance, pharmaceutical manufacturers have an extremely short time to prepare. There are three primary options for Pharmaceutical Manufacturers to consider: a 2D Mass Serialized Bar Coding Solution (item-level and case level with parent/child), a 2D/RFID Hybrid Solution, or a full-RFID solution. Unless you are already down the RFID path, it might be difficult to prepare your infrastructure, launch a Pilot, and deploy a full RFID solution in the time required. Many pharmaceutical brand owners are choosing a 2D bar coding option for the item level coupled with RFID at the case level as a means to get started. In parallel, they are beginning to evaluate an item level RFID option to support wholesalers needs for electronic tracking and tracing of products throughout their operation, removing ‘line of sight' bar code read requirements. At this session, attendees will learn how they can: Meet the California ePedigree Law using one of the above options (comparative benefits and challenges) Leverage the benefits and use of 2D mass serialized bar coding Integrate 2D mass serialized codes at the item level on labels and folding cartons Write item-level codes to a case-level 2D bar-code or UHF RFID tag to create a parent/child relationship between item level units within the case Pilot, integrate, and deploy a 2D Solution, Hybrid Solution, or a Full RFID Solution with a comprehensive network of best in class product and service providers (includes software, hardware, packaging line & quality specifications updates, and packaging components) Leverage the flexibility of 2D bar coding for product authentication and other layered overt, covert, or forensic options
Speaker:
Craig Curran - Director, Strategic Initiatives, Nosco, Inc.
Thursday, March 27, 2008
T-8: The Next Generation of Process Automation - The User's Requirements 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1970's, the Programmable Logic Controller revolutionized the machine control industry. In the early 1980's, proprietary Distributed Process Control systems and microprocessor-based sensors and actuators facilitated large-scale digital plant automation for the first time. Later that decade, the personal computer made application-based automation and control inexpensive and scaleable. The S88 and S95 standards, in conjunction with GAMP4 guidelines, has given a framework for developing, documenting, and maintaining automation and process control systems for the pharmaceutical industry. Over the past ten years, however, while the industry has seen the introduction of new applications and smarter sensors and actuators, the author feels, as do a large percentage of end users, that a new paradigm in automation and process control is needed. The recent “advances” in automation have mostly come from vendors who have created different flavors of existing technologies in order to maintain market share and sales targets. In the process, application spaces have become crowded, “data” has been generated by the terabyte without much focus on “information”, and there has been a slow, but noticeable shift back to proprietary hardware platforms and software applications. It is time that end users voice their User Requirements for this next generation of automation and process control. This session will highlight the requirements of end users specifically, independent of any vendor or automation platform. The author has developed a survey and will conduct interviews which will target hundreds of end users in the pharmaceutical industry asking for input as to what this new generation of automation and process control system should look like. This session will reflect the results of this industry-wide interviews and survey, not those of the author. This session will focus on the user's perspective for the next generation of I/O subsystems, automation controllers, information processors, data historians, batch execution engines, and manufacturing execution systems.
T-12: The Price of Excellence: Examining the Value of Investments in PAT 9:00AM - 10:00AM (Thursday, March 27, 2008)
This presentation will discuss the synergistic aspects of combining process analytical technology (PAT) and Lean manufacturing for operational excellence (OpX). A method for estimating the value of achieving excellence in your operations will be described using published case studies and performance benchmark data. Additionally, the cost-benefit tradeoffs of different technology and project management strategies will be explored. Managers considering incorporating PAT, Quality by Design (QbD), or OpX initiative into their operations are encouraged to attend.
T-9: cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations 10:15AM - 11:15AM (Thursday, March 27, 2008)
Pharmaceutical R&D and Manufacturing has not changed its fundamental paper-based infrastructure in decades. The principle reason is that science by nature and regulatory requirements resist change. Recently, industry and FDA have been more aligned with respect to utilizing innovation and technology to bring manufacturing processes into the 21st century. Leading companies are adopting a new approach to automating the non-value added tasks associated with paper processes in QC and batch record management. The dominate strategy is utilizing innovative technologies (such as Electronic Notebooks) and building quality into the research, quality and compliance infrastructure. The paper will discuss the current situation in cGMP lab and production floor operations relative to FDA initiatives in manufacturing and the broad opportunity for electronic notebook processes. The paper will profile an innovative “method and SOP-centric” software platform, designed to electronically execute and manage laboratory protocols, and production batch records, yielding significant reductions in overall method execution cycle times and electronically capture all data and metadata in a common repository. In addition the GMP Electronic Notebook System provides a Lab Execution System (LES) layer within the GMP IT infrastructure to provide seamless integration of the data capture steps in operating a lab or batch record process to LIMS and ERP systems.
John Helfrich - Director, GMP Lab Automation Programs, VelQuest Corporation
T-13: Application of PAT in Product Development 10:15AM - 11:15AM (Thursday, March 27, 2008)
The Process Analytical Technology, PAT, initiative encourages innovation in pharmaceutical development, manufacturing, and quality assurance to enhance understanding and control of the manufacturing process. The challenge for many manufactures is to identify how best to address the opportunities that PAT offers. Broadley James, Emerson Process Management, and the University of Texas are working together to examine and quantify the potential to reduce cycle time and out-of-spec product through the use of high fidelity, dynamic simulation and multivariate analytics. The objective of this work is to show that the impact of PAT can be maximized through the integration of these tools during product development (PD). Experiments are being run using a CHO cell line and 7 liter bio-reactors. In this presentation, information will be provided on the capability developed for fidelity process modeling of the mammalian cell cultures. A design of experiments (DOE) is described that minimizes the time and tests required to identify model parameters. Examples will be presented to illustrate how this simulation capability in a virtual plant is being used to find the best approach in stepping process inputs and operating conditions and how the improvements found through simulation are verified through experimental test. Also, information will be presented on innovations in PCA/PLS analytics for fault detection and end point prediction of quality parameters. Details will be provided on work that is being done to verify detection of faults and accuracy of end point prediction of quality parameter. Plans for future work will be presented that include applying this simulation and analytic capability during scale up from 7 liter to 50 liter disposable reactors.
Yang Zhang - Research Assistant, University of Texas, Austin
T-10: RFID on the Packaging Level - How to get the Chip on the Box! 2:00PM - 3:00PM (Thursday, March 27, 2008)
RFID is an emerging technology to be used in volume for the identification and tracking of goods. For contactless communication with pallets, boxes and individual items an RFID label is applied onto the goods. Due to an intended one-way use the cost target for a smart label currently is five US cents or less. To achieve this ambitious goal the development of novel manufacturing strategies for RFID products is of major importance. Several attempts are made to streamline the production process with the goal to create a smart label on the packaging level. The improvements in printing of conductive inks for antennae in combination with pre-packaged RFID chips (so called straps) open new opportunities to move from a relative costly slap-and-ship approach to an integrated smart label production process on the packaging level.
T-14: Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT 2:00PM - 3:00PM (Thursday, March 27, 2008)
In the past, unacceptable product batches were prevented from entering the market only by laboratory testing of the finished product – posing risk to the public and wasting both time and money for pharmaceutical manufacturers. In the new regulatory environment, the challenge is to assure the appropriate quality outcome in “real time” by implementing appropriate systems into the process itself, assuring product quality while the batch is being manufactured versus relying on final product testing (RTQA). The increased emphasis on manufacturing process excellence through “Quality by Design” (QbD) requires manufacturers to make larger investments earlier in the product life cycle with the goal of developing a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. Manufacturers have the opportunity to develop a “Design Space” that takes into account the need for different Control Spaces to accommodate future changes in the scale, economics or other aspects of the commercial manufacturing process in the later stages of the product life cycle (ICH Q8). This, along with the adoption of QbD and a quality system as described in ICH Q10, will enable pharmaceutical manufacturers to achieve the “Desired State” of manufacturing. To realize the benefits of implementing QbD, it is critical that CPP and CQA be identified and understood during process development, so they can be measured and controlled in real-time during the manufacturing process. This requires a corporate culture of continuous improvement without the need for regulatory intervention to approve changes. It also calls for close collaboration between the process development and manufacturing teams to achieve a sufficient level of Process Understanding prior to regulatory approval of the commercial manufacturing process. And, of course, it requires the deployment of appropriate, enabling technologies. Such technologies provide a single point of on-demand access by multi-disciplinary users to all relevant data in multiple, disparate data sources (in the same environment with analytics) to identify and understand cause-and-effect relationships in process data and easily share results. Process improvement and QbD will become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time more productively on science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of QbD.
Speaker:
Justin Neway - Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
T-15: Implementing Process Analytical Technology in a Regulatory-Friendly, Single-Use Biomanufacturing Process 3:15PM - 4:15PM (Thursday, March 27, 2008)
We report successful implementation of new technologies for on-line monitoring and control of cell culture in a disposable, animal origin-free process. Recombinant human antibody was produced by a well-characterized cell line using a chemically-defined, animal origin-free culture medium and disposable, stirred-tank bioreactors. Traditional methods of monitoring process variables were compared.
Cory Card - Regional Technical Support Manager, Thermo Fisher Scientific
T-11: Implementing a Service Oriented Organization in IT 3:15PM - 4:15PM (Thursday, March 27, 2008)
Merck's Global Application Engineering & Operations organization adopted a Service Oriented Organization model to become more lean and flexible. Specifically, this company wanted to improve its ability to manage and share global IT capabilities, to deliver quantifiable cost benefits to the business and to deliver higher-value strategic services to its clients. To this end, Merck adopted a new IT Operating Model that was built on three key elements: 1. Shared Services Delivery Structure 2. Professional Services Organization Model 3. Running IT as a business Throughout the transformation, Merck's efforts were informed by the IT Process Improvement frameworks, ITIL and CMM. Concepts of Relationship Management, Service Level Management and Financial Management served as key enablers for the Operating Model. Additionally, Process maturity was seen as fundamental to the new operating mode. To this end, an assessment was conducted of the group's processes compared to the ITIL and CMM frameworks. A custom transformation plan was developed to help achieve the business goals on an accelerated timeline. This included the development of a unique, quantitative Maturity Model to measure progress toward the fully operational state. Merck achieved powerful benefits as a result of this program including cost savings of greater than $ 20 Million in the first year of operating in the new model. Using Merck's project as a case study, the speakers will discuss the following topics: · Merck's Goals · The Service Oriented Organization · How Process Improvement Supported the Strategy · The Transformation Approach · Using a Maturity Model · Results To Date / Lessons Learned
