This handbook focuses on the operations which promise to produce genetically engineered materials for use in producing such end products as: enzymes, antibiotics, hormones, peptides, polypeptides, proteins, amino acids, veterinary drugs, steroids, herbicides, growth promoters, liposomes, diagnostic kits for infectious diseases, and many other materials that focus on pharmaceutical needs. The information in this volume should be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces such issues as: should the process be batch or continuous, or a combination of both?; how should the optimum process design be developed?; should one employ a new revolutionary separation which could be potentially difficult to validate, or use accepted technology which involves less risk?; should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water?; should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible?

Table of Contents:
1 Mechanical disruption of cells.- 2 Conventional filtration.- 3 Pharmaceutical applications of liquid-liquid extraction.- 4 Affinity adsorption.- 5 Membrane separations in downstream processing.- 6 Electrodialysis.- 7 Large-scale column chromatography — a GMP manufacturing perspective.- 8 Product recovery and purification via precipitation and crystallization.- 9 Lyophilization.- 10 Drying in the pharmaceutical and biotechnology fields.- 11 Sterilization in the pharmaceutical and biotechnology industry.- 12 Pharmaceutical packaging operations.- 13 Clean-in-place and sterilize-in-place systems.- 14 Controls and automation for biotechnology and pharmaceutical industries.- 15 Agitation in fermenters and bioreactors.- 16 Distillation in the pharmaceutical industry.- 17 High purity water.- 18 The facility design process.- 19 Clean room testing and certification.- 20 Regulatory considerations.- 21 Validation.- 22 Project execution for the design and construction of a biotechnology facility.- 23 Bulk pharmaceutical and biopharmaceutical plant design considerations.- 24 Optimization of protein recovery using computer-aided process design tools.- 25 Off-site construction.- 26 Waste water treatment in the pharmaceutical industry.