WHAT NEW TECHNOLOGIES AND DATA CAN DO FOR PHARMA AND DRUG MANUFACTURING

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1 WHAT NEW TECHNOLOGIES AND DATA CAN DO FOR PHARMA AND DRUG MANUFACTURING Increase Quality and Safety of Products, and Improve Performance with New Technologies and Continuous Availability simplify and modernize automation

2 CHALLENGES AND OPPORTUNITIES IN PHARMA AND DRUG MANUFACTURING TOP 3 CHALLENGES IN PHARMA MANUFACTURING Quality and safety: ~50% + cite contamination and cleaning as highest risks and most frequent cause of significant unplanned downtime or quality problems* Agility and speed to market: Getting new drugs to market faster -90% Productivity improvements: -90% cite equipment metrics and trend analysis as necessary for improvement of equipment operation; 80% focus on equipment uptime The pharma and drug manufacturing (PDM) industry is facing complex challenges and market dynamics that are changing traditional manufacturing processes that have been in place for decades: Biologics and patient-specific medicines are on the rise Long-standing patents are expiring, eroding first mover advantages Quality control is an ongoing concern due to ever more stringent regulation Drug coverage from insurance companies remains uncertain Simplifying and speeding time to market for new offerings is a business imperative In this environment, pharma manufacturing companies are pressed to adopt more agile processes and modernize their underlying technologies, so that they can quickly adapt production to demand while ensuring product compliance with quality and safety standards. Under these conditions, most pharma manufacturers focus on ensuring product safety, and generating productivity improvements and cost reduction as their top priorities. This ebook provides an overview of some of the trends, challenges and opportunities in the pharma and drug manufacturing markets today and discusses some key operational technologies that pharma manufacturers need to address them. The keys to better operational decisions and increased efficiencies lie in updated industrial automation and information systems that are future-proof and cost-effective, while providing new sources of data, along with new insights from data analytics solutions and monitoring applications. From Operational Challenges to New Solutions Updated automation and manufacturing systems New technologies to monitor, digitize and streamline processes Need for a foundation of simple to operate, always on, cost-effective systems infrastructure * PharmaTech Survey %+ average: 48% of solid-dose and 58% of parenteral manufacturers, respectively PAGE 2

3 PHARMA MANUFACTURING COMPANIES ARE STARTING to make use of cost efficient new technologies to improve operational performance and deliver agility and product safety NEW TECHNOLOGIES: Process Analytical Technologies (PAT) Continuous Manufacturing and Continuous Availability Technologies Modular, Single Use Systems Manufacturing Execution Systems (MES) Digitization of packaging, labeling and serialization Integration of production/ automation and business systems information PROCESSES THAT BENEFIT FROM NEW DATA SOURCES AND NEW TECHNOLOGIES Optimized manufacturing processes Quality and safety monitoring and compliance Supply chain tracking and optimization Forecasting and capital budgeting New capacity deployment OPPORTUNITIES WITH NEW TECHNOLOGY Real-time decisions utilizing new data sources Continuous data capture, monitoring and reporting for optimized decisions and compliance Future-ready smart technologies with a proven return Extended equipment lifecycles KEY TAKEAWAYS Many pharma and drug manufacturing control systems are badly in need of updating as they run on aging hardware with outdated and often unsupported or costly to support operating systems and software applications. Virtualization continues to drive demand IIoT data collection and data analytics for always-on, fault-tolerant systems. PAGE 3

4 A DEEPER LOOK AT TOP CHALLENGES AND REQUIREMENTS Pharma and drug manufacturing players operate in a complex environment - while demand for drugs is fluctuating, pricing pressures are mounting from both generics and changes in laws and regulations, and scrutiny around quality and safety is tightening. A number of new technologies are availability to address these specific requirements. To enable these technologies, pharma and drug manufacturers need modernized operational technology and simple to operate, costeffective, future-ready computing infrastructure to guarantee the uninterrupted operations and capture of data. Ensuring Quality and Safety with New Technologies: Quality and safety continues to be the number one concern: Quality recalls are becoming more commonplace - maintaining consistent purity while avoiding over-recalling is a major challenge Sourcing, traceability and proof of origin mandated by regulators (e.g. the FDA Drug Supply Chain Security Act in the USA) create the need for serialization and ensuring data integrity Compromising sterilization of the production process could be a major cause for unplanned operations downtime The Need for New Drugs: Aging populations, expiring patents, fierce competition of the generics drugs, and the rise of biologics and niche drugs are driving the need to create new drugs even faster: To respond to shifting market demand, manufacturers need to continue to look for new ways to enable modular and scalable manufacturing Manufacturers need to adopt flexible production methods that will allow them to get new drugs to market faster PAGE 4

5 A DEEPER LOOK AT TOP CHALLENGES AND REQUIREMENTS (CONT'D) The Mandate for Productivity Improvement: To make up for the costs of these market pressures, manufacturers need to streamline processes and adopt modern technologies: Replace heavy-manual processes and enable operators through smart automation and decision support systems Extend equipment lifecycles to improve return on assets (ROA) Deploy versatile equipment to achieve agility and be able to shift manufacturing to different, highly demanded products quickly Integrated end-to-end business and manufacturing processes, along with a modular equipment approach allow for quick adaptation of production to different drugs, and ultimately lower capex and quicker time to production PAGE 5

6 PHARMA MANUFACTURING TOP TECHNOLOGY TRENDS PROCESS ANALYTICAL TECHNOLOGY (PAT) FDA s PAT initiative set a legal framework in the USA aiming to motivate pharma manufacturers to improve the production process and achieve consistent quality while reducing waste and costs. To comply with this regulation, pharma manufacturers need to have systems in place that ensure detailed monitoring of their continuous and batch processes PAT enables and drives continuous manufacturing. It was identified as the most important area of innovation in pharma manufacturing along with integrated manufacturing business and automation processes By most estimates, 25% 45% of pharma manufacturers use PAT and 25% - 33% plan to implement PAT in 2017 PAT creates further opportunities for data capture and analyses through IIoT-enabled technologies BATCH VS. CONTINUOUS MANUFACTURING Traditionally, sterilization needs have driven batch manufacturing which has been the main production method in the PDM industry for the past several decades. Slowly, the industry is moving towards more continuous manufacturing in order to increase productivity. According to the PharmaTech 2016 survey: 40% of solid-dosage manufacturers use continuous manufacturing practices But only 10% consider it the most important area for innovation in pharmaceutical manufacturing More than 70% cite significant costs as a barrier to adoption of continuous manufacturing PAGE 6

7 PHARMA MANUFACTURING TOP TECHNOLOGY TRENDS MES (MANUFACTURING EXECUTION SYSTEM) ADOPTION The pharma industry has seen the fastest growth in MES adoption among all manufacturers, which resulted in replacement of manual data collection with electronically collected and stored operations data MES has enabled pharma manufacturers to start monitoring quality control and documentation for regulatory compliance purposes PACKAGING, LABELLING AND DRUG SERIALIZATION INNOVATIONS Proper tracking, tracing and labelling are a must for proof of authenticity and prevention of drug counterfeiting With the digitization of labeling information, more and more emphasis is placed on collecting, securing and processing digital data about products Today, MES systems are gradually being moved to the cloud. As data security and privacy are top concerns, many manufacturers are looking to private or hybrid clouds as a solution, including extending their MES systems to the edge on premise PAGE 7

8 A SIMPLIFIED AND CONTINUOUSLY AVAILABLE INFRASTRUCTURE THE BACKBONE OF MODERN PHARMA MANUFACTURING To keep up with market trends and deploy automated technologies in the modern pharma plant, manufacturers need to have a reliable, simple to operate, always-on underlying infrastructure in place. They need to look for modern, reliable technology solutions that allow them to: Utilize automation and controls to track and control processes and minimize human error Make real-time decisions within manufacturing processes and along supply chains Provide continuous data monitoring and reporting to ensure quality and safety compliance Track and trace all product data to be able to efficiently process recalls Deploy smart technologies with a proven return on investment for continuous manufacturing processes (e.g. IIoT and process monitoring systems, single-use manufacturing systems, disposables, data analytics, etc.) Extend the equipment lifecycle PAGE 8

9 A SIMPLIFIED AND CONTINUOUSLY AVAILABLE INFRASTRUCTURE THE BACKBONE OF MODERN PHARMA MANUFACTURING (CONT D) To provide all those benefits, modern pharma manufacturing operational technology needs to be continuously up and running every minute of unplanned downtime results in critical loss of data and additional costs. Eliminating unplanned system downtime and the risk for data loss is not an option in modern pharmaceutical manufacturing it s a must. Simplified, always-on, cost-effective operational technology allows pharma and drug manufacturing leaders to face the market challenges of today and seize the growth opportunities of tomorrow by: Preventing interruptions in data collection or data loss which may result in safety risks or non-compliance Capturing and processing traceability and serialization data mandated by regulators Enabling automation, software application and legacy-system integration for agility and responsiveness while not having to add qualified IT staff Reducing technical and business risks and improving efficiencies (process, labor, energy, etc.) Future-proofing the infrastructure for IIoT and the continuously advancing manufacturing technologies. Protecting their data, customers, brand and reputation PAGE 9

10 KEY TAKEAWAYS: MAXIMIZE EFFICIENCIES AND PRODUCTIVITY THROUGH SIMPLIFIED AND MODERNIZED AUTOMATION. ENABLE THE UNINTERRUPTED COLLECTION, PROCESSING, ANALYSIS AND REPORTING OF MULTIPLE DATA SOURCES. DRIVE VISIBILITY, RAPID RESPONSE AND FORECASTING WHILE ENSURING SAFETY AND EFFICIENCIES. Stratus takes the complexity out of keeping business critical applications running 24/7. Our technologies proactively prevent instances of unplanned downtime both in the data center and at the edge, and our services ensure any issues are addressed before our customers need to. Global Fortune 500 companies and small medium sized businesses in a wide range of industries across the globe have been relying on Stratus for operationally simple, continuous availability for more than 35 years. FOR MORE INFORMATION, PLEASE VISIT OUR WEBSITE Or follow on