ABSTRACT
INTRODUCTION This chapter “Aspects of Biological and Biotechnological Medicinal Products” covers primarily quality and quality-related safety issues connected with the following biological/ biotechnological manufacturing techniques:! Growth of strains of microorganisms and eukaryotic cells! Extraction of substances from biological tissues, including human, animal, and plant tissues
(allergens)! Recombinant deoxyribonucleic acid (rDNA) techniques! Hybridoma techniques! Propagation of microorganisms in embryos and animals! Advanced Therapy medicinal products. In addition some important nonclinical and clinical aspects will be discussed briefly. Themanufacture of biological/biotechnologicalmedicinal products (“biologics”) involves
certain specific considerations arising from the nature of the products and the processes used to make them. Furthermore, the ways in which biological/biotechnological medicinal products are produced, controlled, and administered make some particular precautions necessary.
