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

    Strategic Issues: Capital Investments

    Abstract

    Biomanufacturing facility design involves balancing the risks and challenges associated with the control of design and construction costs and schedules in order to meet corporate goals and expectations. The need to “get it right” is as important to a business’s bottom line as any aspect of their operation. Regardless of the project size, production technology, product type, or product category there are many ways to spend capital. Biomanufacturing projects generally take the form of four primary facility categories, either as individual or multiple types. Each facility category has its own set of design attributes that can impact capital investment via project cost and schedule. In each category, the process drives the design. This is true because “the process is the product.” This chapter covers Pilot Plants Facility design, contract manufacturing, bulk manufacturing facilities, product types, production technologies, product categories, and the impact of those category attributes on design. In addition, general estimate ranges for attributes of “Typical” facilities are provided. We cover equipment costs, and ither cost factors, based on scale of operation and current trends in equipment design (eg perfusion vs fed-batch reactors). We also cover trends for the future as the biotech industry continues to mature.

    About the Authors

    Jeffery N. Odum, Principal
    ncBIOsource, Raleigh, North Carolina

    Jeffery N. Odum is the founder and Principal of ncBIOsource, a strategic consulting firm for the Biotech Industry. He has more than 25 years of professional engineering and construction experience that has been primarily focused on process-driven technology projects. The last 15 years of Jeff’s career have been focused on the biopharmaceutical industry, specifically in the area of large-scale biomanufacturing. Jeff is the North American Education Advisor for ISPE, where he is involved in the development and execution of education and training programs for the Pharmaceutical and Biotech Industries worldwide. He is also a member of ISPE’s Technical Training Staff, providing industry-focused training internationally. Additionally, Jeff is the current Director of the North Carolina Community College System’s BioNetwork Validation Academy. Jeff is the 2002 recipient of ISPE’s Richard Purdy Distinguished Service Award. Throughout his career, Jeff has written numerous articles on GMP compliance and design and construction issues and published an industry reference guide, Sterile Product Facility Design and Project Management, CRC Press, which is currently in its second printing, and has contributed chapters to five other reference books on various topics in design, validation, construction, and project management.


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