Implementation and execution of Cell and Gene Therapy Manufacturing. cGMP and automated process. Closed loop process. Formulation, cryopreservation.

Cellagilty is developing Clinical grade induced Pluripotent Stem Cells to cater to the need of upcoming Clinical trials and Therapy. Its associated with Kyoto University, Japan for Science and Technology.It has also developed a novel stem cell culture medium which has the potential to revolutionize the culture media market segment. The novel stem cell culture media will be completely protein free and chemically defined.My role involves development, validation and scale up of the… Show more Cellagilty is developing Clinical grade induced Pluripotent Stem Cells to cater to the need of upcoming Clinical trials and Therapy. Its associated with Kyoto University, Japan for Science and Technology.It has also developed a novel stem cell culture medium which has the potential to revolutionize the culture media market segment. The novel stem cell culture media will be completely protein free and chemically defined.My role involves development, validation and scale up of the technologies in an controlled cGMP environment. Design and build Cell Processing Unit for all the activities catering to iPSC and Media development. Setting up the lab and facilities for smooth functioning of research and manufacturing operations. Handling all the procurement related activities at site to ensure on time delivery of materials and equipments to the facility, Show less

 Coordination with the Transplant centre for release of sample for transplantation and organize all the requirements for the tranpant centre. Coordination with QA, Finance, Administration and Procurement to ensure smooth functioning of the Laboratory. Recruitment, Training and Monitoring of staff required for the Laboratory. Conducting periodic appraisals, monitoring performance and consistent feedback to the team for achieving peak performance. Planning of construction of… Show more  Coordination with the Transplant centre for release of sample for transplantation and organize all the requirements for the tranpant centre. Coordination with QA, Finance, Administration and Procurement to ensure smooth functioning of the Laboratory. Recruitment, Training and Monitoring of staff required for the Laboratory. Conducting periodic appraisals, monitoring performance and consistent feedback to the team for achieving peak performance. Planning of construction of lab/plant in accordance with the regulatory compliance. Organize Monthly/Weekly meetings with management for updates and approvals for further improvements and escalations. Report authorization of all the CBU’s stored and ensure the reports are dispatched within TAT. Product training to Sales and Marketing staff as part of knowledge transfer. Plan and implement validations for all the processes involved in the laboratory. Represent the organization in conferences and provide seminars on Stem Cell Technology and Cord Blood Banking. Budgeting for all the laboratory materials/maintenance based on the projections. Drive lab, procurement, stores and logistics for compliance. Ensure safety of all the employees at the laboratory. Ensure completion and continuation of all accreditation to the laboratory: AABB – American Association of Blood Banks and Cellular Therapy ISO 9001:2008 – International Standards Organization for Quality Management WHO GMP – Good Manufacturing Practices NABL – National Accreditation Body for Testing and Calibration Laboratory. DCGI (CDSCO) – Drug Control General of INDIA Show less

 Recruitment, Training and Monitoring of staff required for the Laboratory. Conducting periodic appraisals, monitoring performance and consistent feedback to the team for achieving peak performance. Leading the lab team for Hematopoietic Stem cells isolation and storage. Leading the team for testing of CBUs stored for compliance and release, including immuno-phenotyping and characterization of CD34+ and CD45+ cells by Flow Cytometer using Guava Flow Cytometer, TNC counts by… Show more  Recruitment, Training and Monitoring of staff required for the Laboratory. Conducting periodic appraisals, monitoring performance and consistent feedback to the team for achieving peak performance. Leading the lab team for Hematopoietic Stem cells isolation and storage. Leading the team for testing of CBUs stored for compliance and release, including immuno-phenotyping and characterization of CD34+ and CD45+ cells by Flow Cytometer using Guava Flow Cytometer, TNC counts by Hematology analyzer, Sterility testing and ID testing using ELISA. Plan and maintain all the equipments in the laboratory for Preventive Maintenance and Calibrations. Troubleshooting of minor issues in the equipments and escalate to the service provider for further resolutions. Manage cryopreservation of the processed Cord blood samples and maintenance of all the Liquid Nitrogen Dewars in the facility. Conducting team meetings for regular updates and work allocation to the team for smooth lab operations. Client report creation and authorization. Data collation of all the clients and authorization of data in both the formats (Hard and Soft copy). Database Management with continual improvement of data flow and approval process. Vendor selection and support to purchase department. Flawless documentation for cGMP activities, including SOP, BMR and MFR preparation. Cryopreservation with Liquid Nitrogen and Maintenance of Dewars. Successfully completed accreditation to the laboratory and facing the following audits: AABB – American Association of Blood Banks and Cellular Therapy ISO 9001:2008 – International Standards Organization for Quality Management WHO GMP – Good Manufacturing Practices NABL – National Accreditation Body for Testing and Calibration Laboratory. DCGI (CDSCO) – Drug Control General of INDIA Assisting QA in all aspects of laboratory operations to build quality in the lab. Promote teamwork and cohesive working in the Laboratory. Show less

 Drive and build the Production team for flawless manufacturing of Mesenchymal stem cells for clinical trials and pre-clinical trials. To ensure the continuous supply of IMP for Clinical and Preclinical trials as per the requirement. Coordinating with Purchase, Quality control, Stores, Quality Assurance, Engineering, Product Development and Clinical Operation teams for smooth functioning of Production activities. To publish a yearly budget for the production team to finance… Show more  Drive and build the Production team for flawless manufacturing of Mesenchymal stem cells for clinical trials and pre-clinical trials. To ensure the continuous supply of IMP for Clinical and Preclinical trials as per the requirement. Coordinating with Purchase, Quality control, Stores, Quality Assurance, Engineering, Product Development and Clinical Operation teams for smooth functioning of Production activities. To publish a yearly budget for the production team to finance department and to publish quarterly, half yearly and yearly forecasts for raw material required to purchase department. Leading the preparations for ISO 9001:2008, DCGI and Due Diligence audits from a production perspective. To face and conduct internal audits as per QA schedule. Inventory Control to maintain the raw material inventory, WIP and FG at optimal levels. Process improvement by revisiting the process parameters and introduction of new processes for improved quality and reduction in cost. Isolation, Expansion, Upscaling, and Cryopreservation Mesenchymal Stem Cells from Bone Marrow Allogeneic Mesenchymal Stem cell production for various Clinical trials like Osteo Arthritis, Critical Limb Ischemia, Liver Cirrhosis etc., Preparation of Master Cell bank (MCB) from Bone Marrow and Working Cell bank (WCB) from MCBs for IMP production. IMP Management – Coordination with the Clinical Operations team, CRO and the PI for safe delivery of IMP at site for Clinical trials. Conducting Cold Chain Management studies for flawless transportation of formulated IMP to clinical trial sites. Ensure production of flawless IMP batches and documentation for compliance. Successfully completed the ISO 9001:2008 surveillance and recertification audit. Flawless documentation for cGMP activities, including SOP, BMR and MFR preparation. Day to day functioning of the cGMP. Show less

 Drive and build the Production team for flawless manufacturing of Mesenchymal stem cells for clinical trials and pre-clinical trials. To ensure the continuous supply of IMP for Clinical and Preclinical trials as per the requirement. Coordinating with Purchase, Quality control, Stores, Quality Assurance, Engineering, Product Development and Clinical Operation teams for smooth functioning of Production activities. To publish a yearly budget for the production team to finance… Show more  Drive and build the Production team for flawless manufacturing of Mesenchymal stem cells for clinical trials and pre-clinical trials. To ensure the continuous supply of IMP for Clinical and Preclinical trials as per the requirement. Coordinating with Purchase, Quality control, Stores, Quality Assurance, Engineering, Product Development and Clinical Operation teams for smooth functioning of Production activities. To publish a yearly budget for the production team to finance department and to publish quarterly, half yearly and yearly forecasts for raw material required to purchase department. Leading the preparations for ISO 9001:2008, DCGI and Due Diligence audits from a production perspective. To face and conduct internal audits as per QA schedule. Inventory Control to maintain the raw material inventory, WIP and FG at optimal levels. Process improvement by revisiting the process parameters and introduction of new processes for improved quality and reduction in cost. Isolation, Expansion, Upscaling, and Cryopreservation Mesenchymal Stem Cells from Bone Marrow Allogeneic Mesenchymal Stem cell production for various Clinical trials like Osteo Arthritis, Critical Limb Ischemia, Liver Cirrhosis etc., Preparation of Master Cell bank (MCB) from Bone Marrow and Working Cell bank (WCB) from MCBs for IMP production. IMP Management – Coordination with the Clinical Operations team, CRO and the PI for safe delivery of IMP at site for Clinical trials. Conducting Cold Chain Management studies for flawless transportation of formulated IMP to clinical trial sites. Ensure production of flawless IMP batches and documentation for compliance. Successfully completed the ISO 9001:2008 surveillance and recertification audit. Flawless documentation for cGMP activities, including SOP, BMR and MFR preparation. Day to day functioning of the cGMP. Show less

Isolation, Expansion, Upscaling and Cryopreservation Mesenchymal Stem Cells from Bone Marrow and Umbilical Cord.Isolation, Expansion of Limbal Epithelial Stem Cells for commercial purpose from Limbus.Isolation, Expansion of Conjunctival Epithelial Stem Cells for commercial purpose from Conjunctiva.Preparation of Amniotic Membrane batches from Placenta under sterile condition.Preparation of Amniotic Membrane graft for LSCD patients.Cord Blood Processing and Isolation of CD34+… Show more Isolation, Expansion, Upscaling and Cryopreservation Mesenchymal Stem Cells from Bone Marrow and Umbilical Cord.Isolation, Expansion of Limbal Epithelial Stem Cells for commercial purpose from Limbus.Isolation, Expansion of Conjunctival Epithelial Stem Cells for commercial purpose from Conjunctiva.Preparation of Amniotic Membrane batches from Placenta under sterile condition.Preparation of Amniotic Membrane graft for LSCD patients.Cord Blood Processing and Isolation of CD34+ enriched plasma and Banking.CFU assay for CD34 cells.Immunophenotyping and characterization of MSCs and CD34+ cells by Flow Cytometer using FACS Calibur.Mycoplasma detection using RT-PCR.Flawless documentation for cGMP activities, including SOP, BMR and MFR preparation.Preparation of facility and documents for Audits.Co-ordinating with QC for various in process and finished product testing.Day to day functioning of the cGMP. Show less

CIP Project completionHandling of Fermentors and Bioreactors.Working with DCS(Distributed Control System)CTP completion of CIP skid.