7Center for drug evaluation and research, center for veterinary medicine, office of regulatory committee Guidance for industry. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance [ EB/OL]. (2015-12- 02 ). http ://www. fda. gov/down loads/Drugs/Guidance Compli- ance Regulatory Information/Guidance/ucm070305. pdf.
8Anurag S Rathore, Krist V Gernaey, Cecilia R C Calado, et al. Process analytical technologies in biopharmaceutical process de- velopment [ J ], Chem Technol Biotechnol, 2015,90 ( 2 ) : 213.
9Anurag S Rathore, Gautam Kapoor. Application of process ana- lytical technology for downstream purification of biotherapeutics [ J ]. Chem Technol Biotechnol,2015,90 ( 2 ) :228.
