7:30am	Registration Opens and Continental Breakfast Served
	MORNING GENERAL SESSIONS: THE BUSINESS CASE FOR SINGLE-USE MANUFACTURING SYSTEMS
9:00am	Welcome and Opening Remarks Timothy Downs, Conference Director
9:00am	The Business Case for Mid- to Large-Scale Single Use Systems This presentation offers a strategic, long-term perspective of the applications and technologies that continue to drive adoption of single-use manufacturing components and systems. You will gain details of the history of disposals, from filtration cartridges and small bags to complete systems for mixing, bioreactors, membrane chromatography and more. You will also understand how to weigh the energy, labor and production costs with single-use systems in order to begin your own company strategic plan.
9:30am	Applications: An Overview of the Most Suitable Applications for Single-Use Manufacturing The applications of single-use systems continue to grow and evolve within the pharmaceutical and bioprocessing industries. This presentation will focus on the applications in use today that have found the highest ROI, and those that have yielded other non-financial benefits that help to prove the business case. Understand how factors such as size limitations, concerns over extractables and absorption, limit the advantages of single-use systems in certain applications.
10:15 am	Case Study:Disposable Bioreactors for Microbial Fermentation There are strong economic drivers to move therapeutic protein production into E.coli and yeast where possible. All disposable systems marketed to date have addressed mammalian cell culture. We will describe a system, the CellMaker Lite2, with high oxygen mass transfer which can match the performance of a stainless steel stirred bioreactor in terms of growth and yield for bacteria/yeast, but saves two thirds of the time. Customer data will be presented. We will describe additional features being implemented to meet the demands of the industrial and production customers. Dr Ian Taylor, Commercial Director, Cellexus Biosystems
10:45 am	Networking Break
11:00 am	Cost Models: Disposable Systems vs Cleanable Systems The single-use and disposable systems have clear advantages for fixed capital costs, but can contribute heavily to the variable costs associated with producing a batch. Integration of these devices can reduce the cost of stainless steel, cost of environmentally controlled GMP manufacturing space and many validation costs, but may add costs for leachables and extractables evaluation and other specialized training and startup costs. In terms of the variable components, these systems may reduce cleaning costs, water usage and sterilization costs, but may add significantly to the cost of consumables. The real benefit of the single-use systems may not be in the cost, but in the flexibility and adaptability that they can offer.
11:45 am	Case Study: Application of Single-Use Technologies in Downstream Purification Recently, a number of new technologies have emerged to complement and, in some cases, replace conventional unit operations such as column chromatography. Among these, one of the most promising is membrane chromatography where a filter with appropriate ion-exchange chemistry is utilized to purify a process stream. This presentation offers a case study of single-use Membrane chromatography systems, which are designed to alleviate many of these issues for intermediate purification and polishing steps, and can purify large quantities of protein at very high flow rates.
12:45pm	Hosted Lunch Break
	AFTERNOON BREAKOUT TRACKS (2 educational tracks)  TRACK 1:  IMPLEMENTATION OF SINGLE-USE MANUFACTURING TRACK 2:  VALIDATION & VERIFICATION
2:00 pm	TR1: Designing A Concept Facility Based On Single-Use Systems This session details the requirements for bioprocess system and biopharmaceutical facility with the addition and integration of disposable components and/or whole systems. Included will be details on facility layout and the construction cost; capital equipment cost comparison; comparison of total installed costs; operating cost comparisons and more.
	TR2:  Qualification and Process Validation of Single-Use Components Employing single-use components greatly reduces the complexity of validation. As there are substantially fewer reusable components, fewer items need to be tracked and extensive validation studies for sterilization and cleaning are eliminated.
2:45 pm	TR1: Scaling a Single-Use System:  In this session you will review the implementation roadmap to scale a Single-Use manufacturing system from >10L to <500L per day. Included in the overview are critical factors that influence decision-making such as effective space and manpower utilization, investment costs, process enhancements, component selection and system design considerations.
	TR2: Biocompatability Testing and Verification Manufacturers run the risk of losing product to the surface of the single-use devices through non-specific adsorption. Because extractables and adsorption tests must be performed for each product and application, they can be very time- and labor-intensive. If there is a last minute change in raw materials, repeating such tests could cause serious program delays. This presentation outlines the challenges posed by disposables in the area of biocompatibility.
3:30 pm	Networking Break
3:45 pm	TR 1: Process Development: The Key to the Transition from Stainless Steel to Disposable Filtration Systems The biggest factor in scaling up stainless steel systems that have been retrofitted with disposable products is process development. This session focuses on outlining the processes, products, technologies and services that will be required at each stage of the transition, from development to production.
	TR 2: Regulatory Requirements for Validation of Single-Use Systems Adoption of disposable processing methods eliminates the possibility of cleaning errors or potential carry-over residues from batch to batch. Not surprisingly, the FDA in their oversight role ensuring risk avoidance in the industry has always been a major proponent of disposable processing. This session outlines guidelines and regulatory requirements for single-use systems.
4:30 pm	TR 1:  Customizing Disposable Systems in a Biopharmaceutical Manufacturing Environment Pre-assembled single-use systems do not inherently leverage the flexibility of the disposable products. This presentation offers details on how manufacturers can customize single-use systems containing filter elements, tubing, bags and connection devices to fit their fixed equipment specifications.
	TR 2: Standardizing Processes and Industry Practice In existence today are several applied test and performance references, some of which are applicable but not specific to bioprocess components or systems. Understand what activity is been done to date to establish industry standards for the use and disposal of single-use process components and systems, including standards on component quality testing, sterilization and bioburden control, extractables and more.
5:15 pm	Day One Concludes

 

7:30am	Registration Opens and Continental Breakfast Served
	MORNING GENERAL SESSIONS: THE BUSINESS CASE FOR SINGLE-USE MANUFACTURING SYSTEMS
9:00am	Welcome and Opening Remarks Timothy Downs, Conference Director
9:00am	Future Trends: Issues and Requirements for Single-Use Solutions Providers The scale of the available single-use systems is increasing to keep pace with the demand for protein therapeutics. The providers of single-use technologies are challenged to focus on a few key aspects when considering application of their devices in licensed commercial manufacturing processes, which is the focus of this opening presentation.
9:45am	Case Study: Single-Use Manufacturing in Vaccine Manufacturing Vaccine manufacturing is one area where disposables can offer tremendous flexibility at research, development, and manufacturing scales.
10:30 am	Networking Break
10:45am	Manufacturer Roundtable: Practical Realities in Single Use Manufacturing This roundtable of experts will offer insight, opinion and dialogue focused on their experiences implementing disposable technologies, including the realities of cost savings, reductions of production lines, disposal options, implementation challenges, barriers to success and more.
11:45 am	Disposal Options and Considerations Single use systems generate additional waste for manufacturers. This session details the various options available when disposing large-scale systems. What factors should be considered in planning for disposal? Understand how biohazardous materials, volume of solid waste generated, recyclability and other factors contribute to your options for disposal. You will cover the pros and cons for major disposal options, including treated and untreated landfills, recycling, incineration, pyrolysis, cogeneration and more.
12:30pm	Hosted Lunch Break
1:30pm	Project Specification and Vendor Selection Guidelines Customers of disposable components and systems are looking for products whose impact on product, facility, and cost management are well-understood. This session provides answers for manufacturers to compile a project specification document and factors to consider when weighing possible vendors and solutions providers.
2:00pm	Processes to Ensure Batch Consistency           This session focuses on how manufacturers and bioprocessors can ensure disposable product consistency and reduce variations that will impact the type and concentration of extracted components into solutions stored within the disposable.
3:00pm	Conference Concludes