Upstream Industrial Biotechnology: Equipment, Process Design, Sensing, Control, and cGMP Operations

An affordable, easily accessible desk reference on biomanufacturing, focused on upstream fermentation, process development, and equipment

Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be major areas of research.

To meet the final product requirements, the upstream process—the biosynthesis of the desired biomolecules by complete living cells or their components—needs to focus on the biochemistry of the final product. Working backwards, the cells or enzymes are then designed in a way that will generate a precise product that will achieve optimal biological activity or clinical efficacy.

Based on Wiley's Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this two-volume desk reference features over eighty self-contained articles on industrial cell growth and gene expression systems; media, cell lines, and process development; bioreactor design, process sensing, and control; process analytical technologies (PAT); and upstream cGMP operations.

Volume 1 of Upstream Industrial Biotechnology begins by providing in-depth information on industrial cell gene expression systems and methods to quantify cell growth in order to design processes that are highly reproducible. The choice of the gene expression platform influences overall process design and final product yield. Media composition, growth conditions and approaches to process scale-up are discussed next.

Volume 2 focuses on equipment, process design, sensing, control and cGMP operations. It includes important engineering information on the materials and design of bioreactors to help achieve optimal growth rates and desired cell concentration.

Critical regulatory guidelines that manufacturers must follow under current Good Manufacturing Practice (cGMP) mandated by authorities, may vary from country to country; however, an international harmonization effort has resulted in common global guidelines (as outlined by the ICH) referred to in the sections discussing process analytical technologies (PAT) as well as upstream cGMP operations.

Major topics addressed in these volumes include:

• Cell line development
• Microbial, yeast, insect cell, mammalian cell and transgenic plant expression platforms
• Industrial bioreactor design
• Bioreactor mixing, mass transfer, scale-down and scale-up
• Engineering aspects of process design
• Upstream process optimization
• Bioprocess monitoring and contamination detection
• Sterilization and decontamination

Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Upstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.

Dr. Michael C. Flickinger is Associate Director for Academic Programs of the Golden LEAF Biomanufacturing Training and Education Center (BTEC) and a Professor of Chemical and Biomolecular Engineering at North Carolina State University, Raleigh.