ABSTRACT
The development of biopharmaceuticals is a complex process that requires significant resource commitments with respect to personnel, time, and money. Given the tremendous cost involved, a well-defined strategy for product development is essential to enable efficient process development and subsequent introduction of the biopharmaceutical into clinical trials. In addition to a strategy for development of the cell culture, purification, formulation, and fill/finish of the drug product, a long-range plan for analytical development and testing that both supports the process development effort as well as provides the analytical methods required for product characterization, release and stability testing is required. This chapter will highlight the critical features of an analytical strategy for biopharmaceutical development and provide guidance towards monitoring the safety, purity, and efficacy of new biotechnology drugs. Please note, however, that the testing methods discussed in this chapter should not be regarded as fixed or all-inclusive.
