ABSTRACT
Analytical testing is one of the most important programs in the biopharmaceutical industry. It starts with raw materials and systems testing and continues through production, purification, formulation, packaging, and storage (1). Analytical testing helps to monitor, control, maintain, and ensure product quality and batch-to-batch consistency. The quality and consistency depend not only on efficient process controls but also on sound analytical controls during different stages of fermentation and purification processes (2, 3). Appropriate analytical testing should be developed to ensure that different manufacturing steps are robust and yield consistent intermediates.
