The industry is facing several challenges that the concepts discussed in this presentation can help meeting: • Produce locally in order to be able to sell in a large number of markets • Produce at an order-of-magnitude lower cost • Time to market increasingly critical • Control core intellectual property • Flexibility to quickly react to changing market conditions. The combination of single use technologies, continuous processing and modular implementation in different levels provides more flexibility and speed at a lower cost than traditional methods. While these technologies have been around for quite some time, it is only recently they are starting to be utilized to a fuller extent. Combined, they make significant contributions to meet the challenges mentioned above. This session provides some answers to the challenge of building a Biotech or Pharmaceutical facility in half the time, at half the cost, and operate it to regulatory standards anywhere in the world. It discusses latest developments and experience of single use, continuous and modular concepts and systems, including • Design and operation of single use process systems • Design and operation of continuous process systems • Standardization and modularization of processes steps, suites and facilities • Implementation examples in Biotech and Pharmaceutical Manufacturing. The session will provide insight to how single use technologies, continuous procession modularization and standardization can help reduce risk, time and cost in manufacturing and facilities projects, domestically and internationally. It will also discuss risks and potential pitfalls and ways to avoid them.