ABSTRACT
INTRODUCTION In the context of this chapter “biological” products are those which are based on or frequently contain materials of human or animal origin. These products not only include vaccines, blood products, and immunological products but also extend to products of biotechnology. These product types might be expected to be made in such a way that the possibility of contamination with viral or other contaminants [including transmissible spongiform encephalopathy (TSE) agents] derived from the animal-or human-sourced materials would need to be taken into account during their development, production and release testing. However, these will not be the aspects that will be discussed in this chapter, instead this chapter will address the issues that need to be taken into account during the development processes and included in the marketing authorization application (MAA) for “conventional” pharmaceuticals containing in the main small molecule active pharmaceutical ingredients (although the concepts discussed could also be applied to materials such as fermentation-produced antibiotics and similar semisynthetic materials).
