Safety Assessment of Biotechnology-Derived Therapeutic Drugs

• Published in: Food Safety of Proteins in Agricultural Biotechnology pp. 149 - 182
• Format: Book Chapter
• Language: English
• Published: United Kingdom CRC Press 2008; Taylor & Francis Group
• Subjects: Botany & plant sciences; Food & beverage technology; Ich S6; Toxicology Studies; Safety Pharmacology Studies; Ich S8; Animal Model; Biological Therapeutic Products; Biological Drug Products; Test Material; Cynomolgus Monkeys; Surrogate Molecules; CP4 EPSPS; Ich S7A; Nonhuman Primates; Ich M3; Biological Therapeutics; Immunotoxicity Testing; Single Dose Toxicity Studies; Intended Patient Population; Safety Pharmacology; Ich Document; GLP Toxicology Study; Carcinogenicity Studies; Tissue Cross-reactivity Studies; Repeated Dose Toxicity Studies
• ISBN: 0849339677; 9780849339677
• DOI: 10.1201/9781420005738-11

Assessment of Biologicals ... 158 6.7 Summary ... 160 References ... 161The emergence of and continuous advancement in recombinant DNA (rDNA), hybridoma, and cell culture technologies has led to an escalating production over the past 20 years of biotechnology-derived therapeutics (therapeutic proteins or biologicals) for use in various clinical indications. Biologicals are protein pharmaceuticals derived from living organisms and are distinguished from conventional (small molecule) pharmaceuticals by their manufacturing processes (biological sources vs. chemical/synthetic processes). Thus, the definition of biologicals encompasses protein therapeutics such as recombinant human proteins (i.e., cytokines and replacement enzymes) and monoclonal antibodies.1 Although vaccines and cell and gene therapy products can also fall under the definition of biologicals, these products have distinctive properties that distinguish them from biotechnology-derived therapeutics, and they will not be discussed in this chapter.