Education Sessions

E-FE6
 Current Trends in Design, Construction, and Delivery of Biopharm Facilities

4 November 12.30-14.30 Track: Facilities and Engineering

ISPE CEUs: 0.2

A successfully licensed biopharmaceutical manufacturing facility requires project planning and execution that is tailored to the unique requirements for GMP biologics production. Facility execution must be accomplished via a thorough understanding of the process and regulatory impact on the project. This session will provide a review of the latest trends, strategies, and techniques being employed by industry leaders to successfully execute these complex projects in a regulated environment. Aspects of biopharmaceutical facility delivery, including strategic planning, programming, integrated facility design, and fast track commissioning and qualification will be explored. Two current large scale Greenfield Biomanufacturing projects, Bristol-Myers Squibb’s Devens, MA facility, and Abbott’s comparison of three projects in Worcester and Puerto Rico, will also be presented as case studies. Additionally, detailed insight and lessons learned will be provided from a case study of GlaxoSmithKline’s Biopharmaceutical Clinical Trial Material Manufacturing Facility Renovation in King of Prussia, Pennsylvania, U.S. Attendees will learn current practices from two discussions led by PARSONS (project panel review) and GlaxoSmithKline. This is a unique opportunity to interface with the managers and sponsors of biopharmaceutical projects who were directly accountable for their delivery.

Take Back to Your Job

  • Explain proper planning and the details of execution management
  • Understand current trends in design and construction considerations in biopharm
  • Implement proven models for integration of commissioning/qualification and startup
  • Leverage lessons learned into a more successful project execution
  • Assess issues on the horizon for delivering biopharm projects.

Who Should Attend

This session is directed at corporate directors, managers, engineers, and scientists who are involved in the delivery of biopharmaceutical manufacturing facilities. The informative and practical approaches to bioprocess implementation will be especially useful to engineering groups and end users that are involved in the creation of new, expanded or renovated GMP manufacturing facilities.

Session Leaders

Session Speakers

  • Daniel D'Aquila, Dir Project Management, CDI Engineering Solutions
  • Gerald Geisler, Director Global Eng, Bristol-Myers Squibb
  • Thomas Hartman, VP, GMP Operations, GlaxoSmithKline
  • David Wilson, Director, Engineering, Abbott Bioresearch Center

 

Sponsors