INTRODUCTION

The purpose of this chapter is to describe the quality attributes and associated tests with acceptance criteria for enzymatic preparations used in biopharmaceutical manufacturing. The quality of ancillary materials, including enzymes, used in biopharmaceutical manufacturing can have an impact on the therapeutic products. Several enzymes are used in this type of cell processing. Examples include trypsin, collagenase, pepsin, and papain. This chapter does not discuss applications of these enzymes but rather focuses on tests to assess their quality as process materials.