In 1999, we commissioned our first large scale submerged (or stirred-tank) fermenters capable of handling bacteria, yeast, fungal and actinomycete cultures. This capacity was further expanded in 2006 on our second site, Biocon Park, to cater to the anticipated additional demand for several small molecule generics such as the statins, anti-obesity products and pharmaceutical enzymes. Our multi-product submerged fermentation facility comprises production fermenters ranging in size from 30,000L to 125,000L and several seed fermenters, nutrient dosing vessels and media batching tanks. Operations are fully automated to control key process parameters such as temperature, pH, dissolved oxygen and nutrient dosing using sophisticated DCS control.

The fermentation and associated downstream suites are dedicated depending on the nature of product. The products mainly fall into three categories:

• Insulin and Analogs
• Immunosuppressants
• Statins

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.

Biocon signed a long-term agreement with US biopharma company Optimer Pharmaceuticals Inc. to commercially manufacture the bulk or active pharma ingredient fidaxomicin. This is among a new class of antibiotics called macrocycles, which is being developed by Optimer to treat serious colon infections such as Clostridium difficile infection. Biocon's expertise in fermentation technology and the team's prior analytical development work with fidaxomicin made it suitable to produce the drug in bulk.