Summary
Overview
Work History
Education
Skills
Awards
Publications
Training
Patents
Disclaimer
Timeline
Generic

Naganathswamy Mandi

Bengaluru

Summary

Dynamic individual with hands-on experience in cell line development and process development and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for daptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals. Developed cell lines for four biosimilar mAbs with productivity in the range of 2 - 3.5 g/L. Scaled-up at 2 L and 5 L scales and process optimization for bioreactor studies to achieve the high cell count and high productivity. Successful expression of Fab molecule in periplasmic space in E. Coli and considered for product development. Several research papers published in peer-reviewed journals (National and International).


Overview

21
21
years of professional experience

Work History

GM, Head - Process development

Veeda Clinical Research Ltd.
09.2023 - 01.2025
  • Responsible for driving the process business including cell line development, upstream process and downstream process development
  • Designed ISO Class 7 clean room for mammalian work
  • Website content creation
  • Meeting clients, presentation and proposal preparation

DGM, Head - Bioanalytical Services Department

Bioneeds India Private Ltd.
04.2021 - 08.2023

GLP compliance facility to conduct regulatory submission studies.

  • Clients/Sponsors communication for proposals, scientific discussions and update on the progress of the projects
  • Team management and assigning teams to the studies
  • Training teams with respective SOPs
  • SOP drafting, reviewing and training for the team
  • Study Director for immunogenicity assays; ADA assays; NAb assays
  • Working on regulatory compliances of facilities and studies
  • Active role in DGCI approval for clinical sample analysis


DGM, Head - Product development

Amthera Life Sciences Pvt. Ltd.
07.2018 - 03.2021
  • Cell line development for biosimilar manufacturing in CHO cell line [dhfr system]
  • Successfully developed recombinant CHO cell lines for four mAbs and tested their suitability at 2 L scale in bioreactors
  • Developed the recombinant cell line for human blood coagulation factor VIII for a BIRAC funded project
  • Successfully set up and run 2 L & 5 L bioreactors
  • Potency testing of the biosimilar products by ligand binding assays along with Reference drug product
  • Cell line characterization for stability, gene expression and gene copy numbers
  • Preparation of documents and filing of applications for obtaining necessary approvals from Govt. agencies [RCGM]

AGM & Head, Cell Line Development/Upstream Department

Bioneeds India Pvt. Ltd.
01.2016 - 06.2018
  • Cell line development for biosimilar manufacturing in CHO system using a CQA based approach
  • Establishment of facility biopharma [biosimilars] product development
  • Study on the products, products identification, sequences identification and verification, Study design for cell line development and upstream process development
  • Capex preparation; instrument evaluation; team management


Research Scientist & Sr. Research Scientist

Lupin Limited
01.2007 - 12.2015
  • Cloning and expression of biomolecules of therapeutic importance in mammalian, E. coli and P. pastoris
  • Recombinant cell line development for mAb production in CHO cells
  • Cell lines for recombinant human Reteplase and human Enterokinase molecules in P. pastoris
  • Identified a novel molecule lethal to E. coli and antidote for it and working towards the development of antibiotic free vector for the cloning and expression of biotherapeutics
  • Construction of vector for hyper expression of recombinant molecules
  • Identified a tag for E. coli system for imparting solubility to bio-therapeutics
  • Preparation of documents and filing of applications for obtaining necessary approvals from Govt. agencies

Sr. Scientific Officer

Panacea Biotec Limited
01.2005 - 12.2007
  • Responsible for protocol development for validation of methods, development of recombinant vaccines for Varicella virus
  • Cloned and expressed vaccine candidate from Varicella virus genomic DNA in E
  • Coli and carried-out its partial purification for the development recombinant vaccine
  • Maintained cell line and virus cultivation for the above gene amplification
  • SDS-PAGE and Western blot protocols development for characterization of recombinant biomolecules

Senior Research Associate

Bhopal Memorial Hospital and Research Center
01.2004 - 12.2005
  • Responsible for establishment of molecular biology, cell culture and radioactive laboratories
  • Genomic DNA isolation from cancer cells and performing inter-SSR PCR

Education

Ph.D. - Cloning, sequencing, and expression of selected region(s) of BVDV virus genome and Mucosal disease susceptibility

Indian Veterinary Research Institute (IVRI)
Bareilly, UP
01.2004

M.V.Sc. - Biochemical characterization of gelatin-binding fragment of bovine plasma Fibronectin

Indian Veterinary Research Institute (IVRI)
Bareilly, UP
01.2000

B.V.Sc. & AH -

Veterinary College
Bidar, Karnataka
01.1998

Skills

  • Operations management
  • Organizational development
  • Hand-on experience in cell line & process development
  • Staff training and development

Awards

  • ICAR-JRF awarded during Master's program
  • CSIR -SRF awarded during Doctoral program

Publications

  • Asn12 and Asn278: Critical Residues for In-Vitro Biological Activity of Reteplase, Naganath Mandi, Kalyana R. Sundaram, Sunil K. Tandra, Suman Bandyopadhyay, and Sriram Padmanabhan, Advances in Hematology, 2010, 2010
  • Construction of a novel zero background prokaryotic expression vector: potential advantages, Naganath Mandi, Prakash kotwal and Sriram Padmanabhan, Biotechnology Letters, 31, 12, 1905-1910, 2009
  • High yielding recombinant Staphylokinase in bacterial expression systemcloning, expression, purification and activity studies, Naganath S Mandi, Sudheerbabu Soorapaneni, Sachin Rewanwar, Prakash Kotwal, BhaskarJyoti Prasad, Goutam Mandal and Sriram Padmanabhan, Protein expression and Purification, 64, 1, 69-75, 2009
  • Over-expression of proteins using a modified pBAD24 vector in E. coli expression system, Sampali Banerjee, Shardul S. Salunkhe, Anjali D. Apte-Deshpande, Naganath S. Mandi, Goutam Mandal and Sriram Padmanabhan, Biotechnology Letters, 31, 7, 1031-1036, 2009
  • A Novel Cytokine Derived Fusion Tag for Over-Expression of Heterologous Proteins in E. coli, Sampali Banerjee, Anjali Apte Deshpande, Naganath Mandi and Sriram Padmanabhan, International Journal of Biological and Life Sciences, 5, 3, 129-133, 2009
  • Genetic typing of bovine viral diarrhoea virus isolates from India, Mishra, N., Pattnaik, B., Vilcek, S., Patil, S.S., Swamy, N., Bhatia, S and Pradhan, H.K., Vet Microbiol., 104, 3-4, 207-12, 2004
  • Characterization of 59 kDa gelatin binding fragment of buffalo plasma fibronecetin, Nizamuddin Ahmed and Naganath Swamy, Indian Journal of Biochemistry and Biophysics, 39, 113-118, 2002
  • Beta-defensin antibiotic peptides in the innate immunity of the buffalo: in vivo and in vitro studies, Das H, Swamy N, Sahoo G Ahmed SU, More T, Altern Lab Anim., 36, 4, 429-40, 2008
  • Screening of Bacterial Recombinants: Strategies and Preventing False Positives, Sriram Padmanabhan, Sampali Banerjee, and Naganath Mandi, Molecular Cloning - Selected Applications in Medicine and Biology, Gregory G Brown, INTECH, 2011

Training

  • Training on mammalian cell line development for Bioptherapeutics at NeuClone Pty Ltd, Sydney, Australia
  • Training on Six sigma [Green belt]

Patents

  • Lethal Gene as a tool for zero background cloning, Naganath Mandi, Shardul Salunkhe and Sriram Padmanabhan, WO/2010/018592 A2, 02/18/10, PCT/IN2009/000377
  • Expression of heterologous proteins in bacterial system using a GM-CSF fusion tag, Sampali Banerjee, Anjali Apte-Deshpande, Naganath Mandi and Sriram Padmanabhan, WO/2010/001414 A1, 01/07/10, PCT/IN2009/000372

Disclaimer

I hereby declare that the information stated above is true to my knowledge and belief.

Timeline

GM, Head - Process development

Veeda Clinical Research Ltd.
09.2023 - 01.2025

DGM, Head - Bioanalytical Services Department

Bioneeds India Private Ltd.
04.2021 - 08.2023

DGM, Head - Product development

Amthera Life Sciences Pvt. Ltd.
07.2018 - 03.2021

AGM & Head, Cell Line Development/Upstream Department

Bioneeds India Pvt. Ltd.
01.2016 - 06.2018

Research Scientist & Sr. Research Scientist

Lupin Limited
01.2007 - 12.2015

Sr. Scientific Officer

Panacea Biotec Limited
01.2005 - 12.2007

Senior Research Associate

Bhopal Memorial Hospital and Research Center
01.2004 - 12.2005

M.V.Sc. - Biochemical characterization of gelatin-binding fragment of bovine plasma Fibronectin

Indian Veterinary Research Institute (IVRI)

B.V.Sc. & AH -

Veterinary College

Ph.D. - Cloning, sequencing, and expression of selected region(s) of BVDV virus genome and Mucosal disease susceptibility

Indian Veterinary Research Institute (IVRI)
Naganathswamy Mandi