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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Managing Large Volume, Single Use Disposables

    Abstract

    This chapter will describe the process for determining the feasibility of applications for single use disposable bags in a typical large scale biopharmaceutical facility with bioreactor working volumes of 10,000 liters or more. The article will include an overview of single use disposable bags, an overview of an applicable biopharmaceutical facility, and potential applications within the facility. The applications will include cell culture bioreactors; solution preparation in media preparation and buffer preparation; solution transfer from the preparation area into the process area; solution storage in media storage and buffer storage; purification; and dispensing raw materials from the dispensary into the process areas. Each application will be evaluated with case studies as examples. The case study will include pros and cons and cost evaluation with feasibility and recommendations. The feasibility of each application will be evaluated relative to process efficacy, cost effectiveness in comparison with fixed stainless steel equipment, required manipulations, and ease of operation. Facility design requirements will be described to incorporate the single use disposable bags into the operation.

    About the Authors

    Louis Martin, Director of Process Engineering, Life Sciences Division, Fluor Corporation
    Louis (Skeet) Martin has approximately 35 years of experience in biopharmaceuticals with the last 22 years with Fluor. His experience involves process engineering design execution, pilot plant operations, and process development. Design responsibilities have included large and small scale cell culture and microbial fermentation. purification, bulk formulation, fill and finish, clean in place systems, process support, high purity water systems, and clean utilities for bulk biochemicals, therapeutic proteins, agricultural proteins, and enzymes.

    Bartow, Malcolm
    Malcolm, Principal Process Engineer, Life Sciences Division, Fluor Corporation, has 16 years of experience as a process engineer. Malcolm has been involved in the design of a number of fermentation projects and a significant number of biotech bulk manufacturing facilities. His bioprocess engineering expertise is grounded in hands-on manufacturing experience. Technically, Malcolm excels in bioreactor design, high-purity water systems, and process controls.

    Schaidle, William J. (Bill)
    Bill, Technical Director, Life Sciences Division, Fluor Corporation, has 27 years of experience in biotech and pharmaceutical equipment design including cell culture, recovery, purification, media/buffer preparation, utilities, and fill/finish. His specific expertise involves design, specification, and selection of hygienic process and clean utility equipment including disposables and modular designed equipment.

    Tuttle, Gene
    Gene, Principal Process Engineer, Life Sciences Division, Fluor Corporation, has 11 years of experience as a process engineer in the biopharmaceutical, environmental, and specialty chemical industry. His experience includes engineering design in purification with start-up, process development, process operations, and management involvement.

    Sandstrom, Dr. Craig
    Craig, Principle Process Engineer, Life Sciences Division, Fluor Corporation, has 12 years of experience as a process engineer in the biopharmaceutical industry with biotech manufacturing experience. Craig has been widely published and is also co-holder of a patent related to biopharmaceuticals. Craig has cell culture expertise including bioreactor and purification system design and optimization including single use disposables technology.


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