The fermentation and associated downstream suites are dedicated depending on the nature of product. The products mainly fall into three categories:
Insulin and Analogs
At the end of the fermentation process, the broth is harvested and processed in different downstream facilities depending on the nature of the product. Purification of Insulin and analogs involves cell harvest followed by several chromatography and crystallization steps and bulk lyophilization. The downstream suite for purification of Insulin is a highly controlled area with supply of HEPA filtered air and utilities like Purified water, pure steam and Water for Injection. The process areas are controlled through Building Management System (BMS).
Recovery of statins and Immunosuppressants (secondary metabolites) typically involves whole broth extraction, concentration by distillation, high pressure and low pressure chromatography and multiple crystallization steps for purification. Due to potent nature of Immunosuppressants, the downstream suite is designed with engineering controls to minimize exposure of product to personnel. Pharmaceutical enzymes are typically recovered from fermentation broth using Microfiltration, Ultrafiltration, precipitation followed by bulk lyophilization.