Purification tools for Monoclonal Antibodies is based on experience gained from purification process development, scale-up, and manufacture of more than 250 monoclonal-based diagnostic and therapeutic products. Ten chapters provide in-depth coverage of major separation mechanisms, process strengths, weaknesses, and method development; all fully integrated with the performance, economic, and validation requirements associated with monoclonals. Whether the next antibody is your hundredth or your first, this book will help ensure that your final product benefits from the best that current purification technology can offer.

Researchers can apply field-tested pre-coordinated protocols without modification for preparation of investigational materials.

Industrial process developers can use the same protocols as foundations for commercial procedures. Detailed discussion of method development issues, including common scale-up problems and their solutions, will focus optimization efforts and minimize time-to-market without sacrificing product quality.

Process operators will develop a deeper understanding of the systems they run. Plus, they will learn to identify frequent sources of process variation, and how to prevent them from evolving into process failures.

Regulatory professionals will find technical validation issues clearly identified, along with the reasons for their importance, and suggestions for experiments to characterize their effects.

Educators will find the 88 Figures, 29 Tables, and nearly 1000 literature citations an invaluable teaching resource, for both the classroom and the laboratory.

Students will likewise find the book a valuable reference, and an excellent introduction to the everyday issues encountered with industrial protein purification.

Precipitation methods: inorganic salts, polyethylene glycol, electrolyte depeletion, caprylic acid, and ethacridine.

Chromatography methods: size exclusion, ion exchange, hydroxyapatite, hydrophobic interaction, immobilized metal affinity, hydrophilic interaction, euglobulin adsorption, thiophilic adsorption, protein A, protein G, lectin affinity and more...

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