Raw Material White Paper

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  • 1. White Paper Supplier-Integrated Support of Biopharmaceutical Raw Material Systems Promotes Operational Excellence and Risk Mitigation Abstract The biopharmaceutical industry is increasingly The challenge for biopharmaceutical manufacturers engaged with concerns about operational excellence, to become more efficient and safe is daunting, safety and risk mitigation. These issues have considering the large number of raw materials required historically affected large-scale pharmaceutical for production and the complexities of cell culture manufacturing but now are gaining prominence systems. However, this challenge can be overcome throughout biological production scale-up and if manufacturers partner with knowledgeable and process transfer. SAFC Biosciences® provides experienced suppliers early in process development. biopharmaceutical clients with supply chain solutions through novel applications of vendor-partnered The Challenge capabilities. This paper presents strategic approaches Unlike small-molecule pharmaceutical for which a to biopharmaceutical process optimization through chemical reaction remains relatively constant through supplier integration that maximize revenue, reduce production scale-up, bench-top biopharmaceutical costs and support reproducibility of production experiments are not necessarily linear to large-scale processes. It also describes how vendor-partnered manufacture because the processes are much more solutions deliver leaner and safer processes for raw complex. Biopharmaceutical processes require material handling. stepwise technology transfers, often with unique processing steps, in order to ensure that the same Introduction product is produced at large scale as at small The biopharmaceutical industry is experiencing a new scale. This stepwise process makes developing paradigm in which risk mitigation and operational biopharmaceutical processes expensive and excellence are prevalent trends. It is no longer enough time-consuming and highlights the need for producers to develop and produce a blockbuster drug candidate; to investigate integrated supply chain solutions early in it is now critical to effectively manage costs, in-process the development process to ensure cost-effective, quality, operational safety and supply chain security. safe, and reproducible systems. No longer is it important to just develop and Recent industry conferences have presented many produce a blockbuster drug candidate. examples of the impact of increased costs from biopharmaceutical technology transfer and added production system complexities. These presentations To help manage the complexity, SAFC Biosciences have shown that raw material costs are now less offers strategic supply chain solutions that assure of a concern than the overall operational costs for batch quality and consistency during manufacture, determining and applying process steps. support complex regulatory compliance and reduce shipping delays, so you stay on time to market and maximize financial results. www.safcbiosciences.com
  • 2. Unchecked variability in technology transfer and The impact on the manufacturing routine of adding production make it difficult to effectively manage multiple components to the production system is not production resources. Assume, for example, that a completely understood until the entire operational 10,000 L production tank is worth about $10 process is reviewed. This full process includes initial million in drug product. +/- 10% due to raw receipt and preparation of raw materials, quality control material or process variability translates testing and charging components for manufacture. into +/- $1 million in final product. Each step pictured on the following page details the If capacity and resource constraints limit cell Total Cost of Ownership (TCO) for each raw material culture and purification runs by 10% a year, a incorporated into the production process, including: potential of $50 million in loss revenue is at risk • Logistics, sourcing and documentation and/or may lead to increased production costs from • Inbound receiving steps outsourcing production to a contract manufacturer. • Unit sampling • QC testing • How can resources be maximized? • Inventory and tracking • How can secure supplies of raw • Media hydration and clean-up time materials be maintained? • How can suppliers be better integrated into overall processes? Adding to the challenge of complex biopharmaceutical systems is the desire for manufacturing facilities to be more flexible. The reality is that more clinical projects are filling the pipeline but fewer on-site resources are available to maximize production output. Below is an example of the complexity that faces biopharmaceutical production engineers. Steps required for production in mammalian-based system can include several feed additions that require time point-specific supplementation: The Integrated Supplier Approach In a February 2006 BioProcess International article, “Managing a Biopharmaceutical Supply Chain,” Allen Jacques, Senior Director of BioPharma Supply Chain at Wyeth, points out the differences and complexities between classical pharmaceutical production systems and present day biopharmaceutical systems. His point is illustrated in the following image (see next page) that compares molecule sizes of the rheumatoid arthritis biopharmaceutical, ENBREL, to the legacy small molecule drug Ibuprofen. www.safcbiosciences.com
  • 3. ENBREL Creative supply chain solutions are best achieved when potential suppliers are integrated early-on into manufacturing processes. For many organizations, this means during process development At this point, suppliers and manufacturers can become intimately connected in a focused approach to long-term process and resource optimization. This interconnected focus approach allows biopharmaceutical manufacturers This statement holds true for all to backwards-integrate with suppliers, positively elements of supply chain and influencing the direction and effectiveness of manufacturing. Creativity is supplier-partner solutions. required to remove constraints currently inhibiting process Understanding the following process scenario is optimization and open opportunities required before actively pursuing and integrating for cost savings, enhanced suppliers into your production processes: reproducibility of production • Map your entire process from development through processes, and greater safety. theoretical production scale • Identify the points where suppliers currently touch your process “It is easy to focus on such differences • Identify areas on the map that currently in our industry as reasons why classical cause constraints supply chain principles do not apply. I • Begin scenario planning to identify the most likely, suggest they are applicable; they just need and worst, operation cases that may affect your to be applied with a measure of creativity.” process efficiency and safety Allen Jacques, Wyeth www.safcbiosciences.com
  • 4. Identify Proven Results 1. How much drug product will be required for A biopharmaceutical manufacturer for whom SAFC clinical trials? Biosciences is a primary supplier of critical raw 2. How much drug product will be required for market materials requested that we work to develop a solution commercialization? to an operational challenge they posed: 3. How robust and effective is your current process in Challenge meeting production goals? • Enhance logistic 4. What is your production capacity? operations capacity 5. What additional process development steps may be - Drum dumping required to reach your production goals? process not 6. What is the outlook for your Bill of Materials (BOM)? optimized 7. How will additional raw material requirements - Dispensing 3,500 kg and processing steps affect your Total Cost - 7,000 repetitions of Ownership? Process Diagram presented by Sartorius Stedim Biotech Once you understand the various scenarios that may impact your commercialization process, you can begin identifying those suppliers best positioned to enhance your production and operational goals. Use the following criteria: 1. What are your BOM needs? 2. Which suppliers provide the majority of your BOM needs? 3. What are your operational constraints regarding raw material supply and production utilization? Solution 4. Which suppliers are focused on the industrial cell • New filling regime and supplier-managed net culture market and can provide custom solutions weighing for your application? - Removed two non-value steps 5. Which suppliers have risk mitigation practices similar to your own? Powder Filling Machine 6. Which suppliers can integrate with other suppliers Servo Driven Auger Filler to provide the optimal solution? • Programmable Logic Control Scale Feedback • Multiple Tooling Sets www.safcbiosciences.com
  • 5. Benefits • Reduced ergonomic safety risks and non-core To learn more about examples of how SAFC labor hours Biosciences has integrated with manufacturers to - Reduced customer dispensing steps by 50%; enhance production efficiency, supply chain security reduced handling exposure and operational safety, visit www.safcbiosciences. - Reduced wasted labor hours from 80 to less than com and click on Case Studies & White Papers in the 20 a week Technical Library in the Overview section. Recognizing the value of To learn more about application-specific solutions this supplier-integrated to enhance your process efficiency, visit relationship, the customer asked how www.safcbiosciences.com. SAFC Biosciences Written by Mason Williams, Product Manager, SAFC; edited by could further improve Brad Riesenberger, Sigma-Aldrich Corporate Communications manufacturing efficiency and supply chain security. This launched a new collaborative effort About SAFC Biosciences: SAFC Biosciences is a leading in which: provider of cell culture materials and development services for • Raw material risk mitigation steps have been upstream and downstream processes in the biopharmaceutical defined for each raw material in the media industry. Providing an integrated services package in formulation mammalian cell culture media development, along with analytical and regulatory support, SAFC Biosciences employs • A three-phase dry powder media transfer approach a wealth of industry experience and scientific know-how to has been recommended, consisting of: deliver reliable, consistent solutions that accelerate customer Phase 1: A powder transfer bag system to ensure success – from development through to commercialization. The powder delivery and safety in a timely manner unit has a 35-year history as a manufacturing partner providing Phase 2: A drum dumper process that relieves leading biopharmaceutical companies with the broadest range manual addition steps of highly customized products and services possible. Phase 3: Design and application of a flexible bulk About SAFC: SAFC is the custom manufacturing and services intermediate contaminant unit to provide as few as group within Sigma- Aldrich that focuses on high-purity one media addition steps, reducing QC sampling inorganics for high technology applications, cell culture requirements and personnel handling steps. Note: products and services for biopharmaceutical manufacturing, Final phase requires capability development and biochemical production and the manufacturing of complex, continual collaborationIdentify multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated SAFC Biosciences Integrated Supplier Approach to providing manufacturing services for companies requiring SAFC Biosciences offers the world’s broadest a reliable partner to produce their custom manufactured range of products, services and capabilities for the materials. SAFC has four focus areas – SAFC Pharma® , SAFC biopharmaceutical industry. SAFC Biosciences partners Supply Solutions® , SAFC Biosciences® , and SAFC Hitech® – with other suppliers, including Sartorius Stedim Biotech, and had annual sales of $624 million in 2008. SAFC is one Vivalis and Novozymes, to provide integrated solutions of the world’s 10 largest fine chemical businesses. For more that impart unmatched value to the industry. information about SAFC, visit www.safcglobal.com. United States Europe Asia Pacific SAFC Biosciences, Inc. SAFC Biosciences Ltd. SAFC Biosciences Pty. Ltd. 13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive Lenexa, Kansas 66215 Andover, Hampshire SP10 3LF Brooklyn, Victoria 3025 USA UNITED KINGDOM AUSTRALIA Phone +1 913-469-5580 Phone +44 (0)1264-333311 Phone +61 (0)3-9362-4500 Toll free-USA 1 800-255-6032 Fax +44 (0)1264-332412 Toll free-AUS 1 800-200-404 Fax +1 913-469-5584 E-mail info-eu@sial.com Fax +61 (0)3-9315-1656 10736-509241 E-mail info-na@sial.com E-mail info-ap@sial.com 0129 www.safcbiosciences.com