Once a decision has been made to increase capacity, what should it cost?
Define your tolerance for lowest cost design and construction. The speakers will provide an examination of the Conceptual Design process and Cost Evaluation of capacity, single-use vs. multi-use operations, redundancy, planned expansion and modularity.
The presentation will focus on pharmaceutical, biotechnology, medical device and healthcare companies and include a live Q&A with the audience.
Carrier Li, Director in Global Asset Planning, Amgen
Carrier Li is Director in Global Asset Planning supporting Manufacturing Asset Planning at Amgen. He has 28 years of experience in the bioPharmaceutical industry. Prior to Amgen, Carrier was Project Design Manager at Merck leading Front-End Planning activities in Central Engineering. Carrier has a bachelor’s degree in Chemical Engineering.
Bob Allen, Senior Director, Facilities Integration, Fluor Industrial Services
Bob began his professional career with Fluor more than 29 years ago after receiving his bachelor’s degree in architecture from Clemson University. His work as a technical director within Fluor’s Facilities Integration Group has given him exposure to a wide range of life sciences and health care projects with industry leading companies such as the Cleveland Clinic, Amgen, Genentech, Biogen, Monsanto, IDEC, Roche, Schering AG, Novo Nordisk, Novartis, and Elan Pharmaceuticals.
His particular area of expertise is the early scope definition and conceptual design of GMP and regulatory compliant biotech and Pharmaceutical facilities. Project type, size, and complexity have varied greatly and include fill/ finish, process development, pilot plant, clinical, launch, and commercial manufacturing facilities in the U.S., Canada, Europe, Middle East, and Asia. He is intimately familiar with all applicable GMP/regulatory compliance issues, bioPharmaceutical unit operations, and associated ancillary support equipment.
Bob is a registered architect and a LEED accredited professional and well versed in sustainable building design principles.
Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services
Craig is one of Fluor’s resident biotechnology experts and is a Director of Process Engineering within the Industrial Services business. He received his PhD in Chemical Engineering from Northwestern University and has more than 21 years of industry experience, with the last 17 years working with Fluor. During this time, he has worked dozens of bioPharmaceutical facility design and optimization efforts, with an installed value in excess of $1.6 billion. These manufacturing facilities have included both drug substance and final drug product, with products including recombinant proteins (monoclonal antibodies, enzyme replacements, hormones, and growth factors), vaccines and human plasma derived proteins, with manufacturing scales ranging from 500 to 20,000 liters (bioreactor or fermenter capacity) for the drug substance facilities and from 5MM to 50MM vials/syringes per year. More recently, Craig has been leading Fluor’s process efforts around facility optimization and capacity planning, focusing on overall equipment effectiveness and operational consistency to unlock existing capacity with minimal facility impacts.
Fluor Corporation is one of the world’s largest publicly traded engineering, procurement, construction, maintenance, and project management companies. Fluor is dedicated to the success of the Life Sciences industry. For over 40 years we have delivered and improved facilities that provide verified capital and operating savings to our clients for their manufacturing needs.