Biotech's 4th Decade: Strategies for Development and Operation of Successful Facilities
Facilities and Equipment Track
As the Biotechnology Industry moves into its fourth decade, dynamic changes are occurring in process development, enabling technologies, operational processes, facility design and integration, and manufacturing strategies. This wave of activity is commonly referred to as the Manufacturing of the Future - a paradigm shift that biotechnology companies must embrace to remain competitive in the modern global environment. Our consortium of experts will provide insight based upon case studies that provide workable strategies to define, deliver and operate successful Biotechnology Manufacturing facilities.
The planning, design, construction, commissioning and validation of highly technical and complex Biotechnology Manufacturing Facilities for the life sciences industries requires an understanding of the industry and its need to satisfy ever-changing scientific, market, operational and regulatory demands for the present and the future. This “short course” will provide an overview of key strategies to:
- Define a facility planning process that translates the user requirements into facility and equipment solutions to deliver functional fit-for-purpose facilities solutions for the Manufacturing of the Future.
- Challenge todays’ design methods like risk assessment and identify the key factors enabling to design the facility of the future.
- Present tools and techniques to identify and understand the impact of variability and uncertainty.
- Confront current approaches that address human error in GMP operations and offer up an alternative that describes a sea change in human error reduction and prevention for our industry.
- Describe how single use components can be used as a substitute for re-usable systems.
- Reveal the dynamic changes that are occurring in process development, facility design and integration, enabling technologies, and manufacturing strategy to meet the needs of the global enterprise.
At the conclusion of this session, participants will be able to:
- Understand concepts focused on the Manufacturing of the Future - new processing equipment options and strategies for new modular facilities based on disposable technologies that maximize flexibility, asset value and speed to market.
- Create strategies for upgrading outdated facilities with new technology and equipment.
- Challenge the "risk based" design approach as the basis for the design of the biotech facility of the future.
- Create a framework and model for HER (Human Error Reduction) in bio-manufacturing influenced by years of knowledge and experience from the Nuclear and Aviation industries.
- Gain insights from the body of knowledge developed as a single industry voice by a leading collaboration consortium comprising HER specialists from 15 of the world’s top biotech companies.
- Develop a means to accelerate the sustained reduction of human errors by deploying proven systems, tailored to the needs of biotechnology manufacturing facilities.
- Understand the use of process simulations and relevant industrial engineering techniques for dealing with uncertainty and variability.
- Define changes to implement to ensure that adaptability, utilization, and flexibility are in synergy with business needs and regulatory guidance.
- Learn how biotechnology companies are reshaping manufacturing using new platforms, analytical technologies, and delivery systems.
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Who Should Attend
- Service Providers
Communities of Practice Members that will Benefit
- Good Control Laboratory Practices
- Operations Management
- Project Management
- Sterile Products Processing