Komal Patel

Experience

• 

  Cadila Pharmaceuticals Limited

  Jun 2011 - Aug 2014

  Technical Supervisor

  • Study animals monitoring, body weight measurement, randomization, labelling.• Dose preparation and Blood samples processing for various analytical purposes.• Performing techniques like Thin layer chromatography, gel elution, cell lysis and dialysis for extraction of intra-cellular proteins. • Buffers and reagents preparation with accurate pH and conductivity for downstream processing.• Protein characterization techniques such as SDS-PAGE, Western blot, Dot-blot and total protein estimation by BCA, Micro BCA, Folin-lowry, and Bradford techniques.• Active participation in all Analytical activities for various project development Show less

• 

  CPL BIOLOGICALS PVT. LTD.,

  Sept 2014 - now

  • Development, qualification and validation of analytical methods for the characterization and quality control of biotechnological products following regulatory guidelines• Planning and executing routine analysis of raw materials, intermediates, and finished products using a variety of techniques such as Protein quantification, Gel electrophoresis, ELISA, HPLC, HCP, HCD, Western blot and Dot blot.• Managing responsibility of potency testing for Drug product and Drug substrate stability samples of Rabies and influenza projects by Potency testing methods.• Hemagglutination test for influenza vaccine Clinical Trial samples.• Playing lead role in planning and execution of Immunogenicity and proof of concept studies for new project development like Human papillomavirus vaccine, Varicella zoster vaccine, Rabies vaccine and Influenza Vaccine • Planning and execution of In-vitro and in-vivo innovation studies for Cancer vaccine development• Animal studies in various models like mice, rats, guinea pigs and rabbits• Polyclonal antibody generation, purification by chromatography and characterization by different techniques.• Evaluation and interpretation of analytical data to support process understanding and troubleshooting• Collaboration and communication with cross-functional teams including Pre-clinical, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure compliance with regulatory requirements• Reviewing accurate documentation including protocols, reports, standard operating procedures (SOPs) and standard test procedure (STP)• Staying updated with the latest advancements in analytical techniques and contribution for continuous improvement initiatives within the department• Effective Communication to Superior as well as subordinates in order to carry out work and its follow up. Show less • Testing of clinical trial samples by Rapid fluorescent focus inhibition test (RFFIT) for Rabies vaccine project.• Implementation of NIH potency test for recombinant Rabies vaccine.• Basic cell culture including revival, sub-culturing and Maintenance of BHK, MNA cells and cell bank preparation.• Preparation of cell adapted Rabies virus banks and mice brain adapted Rabies virus banks, its maintenance and titration. • Implementation of Plaque assay for recombinant Baculovirus samples and Influenza Drug product, Drug substrate stability samples.• Method validation for antibody quantification by ELISA for Varicella zoster vaccine and Human papillomavirus vaccine development• Planning and Execution of different in-vivo proof of concept studies for ThRabis vaccine development• Preparing documents like protocols, reports, standard operating procedures (SOPs) and standard test procedure (STP). Show less • Immunodiffusion testing for influenza vaccine Drug product and Drug substrate stability samples.• Immuno-profiling experiments using various techniques – FACS (Flowcytometry), ELISpot, ELISA for cytokines and immune cells.• Spelnocyte and macrophage isolation & culturing from animal species.• Cell-based assays such as Effector cell function, MTS and Cell cytotoxicity assay.• Execution of cell-based virus titration assays like Rapid titre assay, plaque assay and Guava assay by FACS.• Method development for antibody quantification by ELISA for Varicella zoster vaccine and Human papillomavirus vaccine development• Training of the subordinates and trainees. Lay down procedure to define responsibility and basic principles for lab personnel. Show less • Immunohistochemistry testing for Desmocollin – 3 detection for cancer vaccine development for different type of samples such as Tissues blocks, cancer cells and PBMCs.• Whole cell cancer Vaccine formulation and lyophilization• Lyophilizer (Freeze Dryer) cycle Monitoring, operation & maintenance of the instrument.• Pre-clinical studies and analytical testing for the development of immunomodulator like Sepsivac and Immuvc.• Animal handling: Immunization, blood collection, Tumour model development, tumour size measurement and Spleen collection.• Preparation of protocols, Standard Operating Procedures, Standard test procedure, reports presentations and program updates.• Technology transfer- Documentation handling and method transfer procedure handling. Show less

  • Deputy Manager

    Jan 2021 - now

  • Assistant Manager

    Jul 2017 - Dec 2020

  • Exicutive

    Jan 2015 - Jun 2017

  • Senior Technical Supervisor

    Sept 2014 - Dec 2014