Process Engineering-Mabs Downstream

Mabs-Downstream Manufacturing

• Synthesis of Peptide (coupling reaction of Amino Acid), cleavage of peptide and purification.• Handling of Microfiltration and ultra-filtration.• Working in classified clean rooms.• Handling and Troubleshooting of Preparative HPLC• Packing and Unpacking of preparative Reverse Phase HPLC LC450 and LC50 (NOVESEP).• Performance of leak test for Lyophilizer40L (LSI)• Trouble shooting of Lyophilizer40L (LSI).• Preparation of BPR and Risk Assessment,• Data compilation and OEE (Overall Equipment effectiveness) on track and improving it.• Training for production personnel on process operations and training for new entrants.• Trouble shooting and CAPA on Equipment failure and process.

• Manufacturing of insulin and insulin analogs and its purification.• Insulin (rDNA) recovering downstream process Ion exchange Chromatography (Pall life sciences).• Crystallization and Transpeptidation of Insulin.• Handling and Troubleshooting of Preparative HPLC LC450, LC600 and LC800 (NOVESEP).• Packing and Unpacking of preparative HPLC LC450, LC600 and LC800 (NOVESEP).• Handling of Microfiltration and ultra-filtration.• Doing dry Heat sterilization, Steam Sterilization and liquid Dehydrogenation.• Autoclave and lyophilizer validation.• Working of classified clean rooms.• Performance of leak test and Sterilization for Lyophilizer40L (Telstar).• Trouble shooting of Lyophilizer40L (Telstar).

• Manufacturing of thiocolchicoside from colchicine by recombinant DNA technology• Thiocolchicoside recovering downstream process Chromatography method.• Handling and troubleshooting of Fermenter.• Handling of Tangential flow filtration and Microfiltration.• Handling of Autoclave and sterilization process.