Virus Concentration, Inactivation and Formulation activities

Ultra Centrifugation for purification of Viral Concentrate1. Purification of Viral Concentrate by continuous flow Isopycnic Ultracentrifugation (Alfa Wassermann K II) using Sucrose gradient.2. Planning and execution of daily operation as per the Filling section requirements.3. Ensuring regular updation and maintenance of documents.4. cGMP compliance of facility and operations as per WHO guidelines.5. Review of SOP’s and generating validation protocols for… Show more Ultra Centrifugation for purification of Viral Concentrate1. Purification of Viral Concentrate by continuous flow Isopycnic Ultracentrifugation (Alfa Wassermann K II) using Sucrose gradient.2. Planning and execution of daily operation as per the Filling section requirements.3. Ensuring regular updation and maintenance of documents.4. cGMP compliance of facility and operations as per WHO guidelines.5. Review of SOP’s and generating validation protocols for experiments.6. Inventory management, SAP entry of daily activities and QC results follow up. 7. Training for employees on SOP, TQM concepts, work ethics and occupational safety.8. Scale up of production from 6.5 to 9 million doses. 9. Initiated awareness and implemented OHS system and aids.10. Project: Stability studies on Purified Rabies Antigen.11. Project: Endotoxin control using detergent (Tween 20) in purification.12. Project: Separation of Rabies virus particles in an Ultra centrifuge using sharp Sucrose gradient method. Show less

Diafiltration (TFF):1. Diafiltration for the Buffer Exchange and Micro solute removal of partially Purified Rabies Antigen.2. Contamination brought to 0 %3. Successfully implemented Continuous Diafiltration method.4. Drastically reduced inventory by introduction of capsule filter and increasing life of cassettes by changes in flushing and sanitation procedures.5. Project: Removal of Micro solutes using Continuous Diafiltration method (cDF) for the purification of Rabies… Show more Diafiltration (TFF):1. Diafiltration for the Buffer Exchange and Micro solute removal of partially Purified Rabies Antigen.2. Contamination brought to 0 %3. Successfully implemented Continuous Diafiltration method.4. Drastically reduced inventory by introduction of capsule filter and increasing life of cassettes by changes in flushing and sanitation procedures.5. Project: Removal of Micro solutes using Continuous Diafiltration method (cDF) for the purification of Rabies Antigen – Process Optimization.6. Project: Sanitization efficiency of 1N NaOH solution comparison with 8% Formalin solution, in a Diafiltration system. Show less

Formulation (Blending) & Filling:1. Formulation of final Rabies Vaccine according to Batch (IP or BP), dose and potency requirements and aseptic blending of ingredients.2. Aseptic Vaccine filling and sealing operation3. Dead-End Filtration and Integrity testing4. Project: Hold time study of Sterilized materials and glassware used in Blending.5. Project: Formulation and Trial validation of Liquid Rabies Vaccine

Media Preparation Section: 1. Preparation of Media - Cell Maintenance Medium like VMM, IFM and MEM for virus harvest and cell step ups. 2. Formulation Adjuvants, Preservative (Thiomersol) and Antibiotics. 3. Buffers like PBC, PBD and PBSA for bio processing. 4. Seeding, step-ups and harvesting of Vero cell lines for infection supply 5. Microbial Growth Media SCDM & FTM for Growth Promotion Testing 6. Operation of Automatic filter Integrity… Show more Media Preparation Section: 1. Preparation of Media - Cell Maintenance Medium like VMM, IFM and MEM for virus harvest and cell step ups. 2. Formulation Adjuvants, Preservative (Thiomersol) and Antibiotics. 3. Buffers like PBC, PBD and PBSA for bio processing. 4. Seeding, step-ups and harvesting of Vero cell lines for infection supply 5. Microbial Growth Media SCDM & FTM for Growth Promotion Testing 6. Operation of Automatic filter Integrity testing machine (Pall-Palltronic Flowstar IV, XC and Millipore Integritest 4) of Sterile-Grade and Clarification grade filters. 7. Media mixing vessel (500L and 250L) periodic maintenance and calibration. Show less

1. Teaching Biochemistry for D.Pharm students2. Teaching Biochemistry and Biotechnology for B.Pharm students3. Pharmaceutical Analysis Lab Instructor for B.Pharm and M.Pharm (Pharmaceutical Analysis) Students4. Experienced in handling and maintenance of analytical instruments (of Pharmaceutical Analysis Lab) like Spectrometer, UV-VIS Spectrophotometer, Colorimeter, Flame-Photometer, Photo-Fluorimeter, Cooling - Ultra Centrifuge, pH meter and Conductivity meter.