Manjunatha S M

MSC.(Biochemistry), Ph.D.(Bioengineering)

  • Behind 10th Block MIT Hostel, Manipal

    India

  • Source: Scopus
  • Calculated based on no. of publications stored in Pure and citations from Scopus
20092021

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Personal profile

Professional Information

Summary

  • Over 10+ years of experience in Mesenchymal stromal cell (MSCs) research and development and manufacturing.
  • Efficiently lead team for manufacturing of MSCs for clinical trials, process improvement and development, next generation manufacturing technology, implementing process as per Pharmaceutical and Medical Devices Agency (PMDA) Japan standards for global cell bank manufacturing.
  • Developed advanced MSCs based process and therapeutic models for treating degenerative diseases.
  • Strong scientific experience in MSCs biology, cell therapy, tissue engineering and regenerative medicine.
  • Successfully co-ordinated between interdisciplinary scientists: co-inventor of 2 patents (applied); co-author of 1 book chapter; first author of 6, corresponding author of 2 and co-author of 14 publications. Total citations 491, h- index 12, i10-index 13 (as on 26 May 2021).
  • Assited in writing funding from various national and international agencies.
  • Effectively mentored students to be productive in research; trained executives on GMP, large scale process, and quality management system.
  • Experience in ISO 9001:2015 Quality management system.

Professional experience

Assistant Professor: Manipal Centre for Biotherapeutics Research (September 2021 onwards)

Manager: Stempeutics Research Private Ltd, Manipal, India (October 2020 to August 2021).

Responsibilities: Lead, Manufacturing of Mesenchymal Stromal Cells for clinical applications and commercial requirements.

  • Driving successful Manufacturing / Process Improvement activities.
  • Developing a strong and cost-efficient production process to deliver MSCs on time to clinical sites and meet commercial demand.
  • Understanding and implementing process as per PMDA standards for global cell banking.
  • Developing, optimizing and implementing robust manufacturing processes for MSCs & stem cell conditioned media products.
  • Develop a team of technical experts through on job training or course enrolment.
  • Identifying automated technology with scientific and regulatory requirements for large scale expansion, downstream and fill and finish process.

Accomplishment: Effectively implemented process as per PMDA, Japan standard for cell banking.

Deputy Manager: Stempeutics Research Private Ltd, Manipal, India (February 2018 to September 2020).

Responsibilities: Lead, Manufacturing of Mesenchymal Stromal Cells for clinical trials.

  • Driving successful Manufacturing / Process Improvement activities.
  • Developing a strong and cost-efficient production process to deliver MSCs on time to clinical sites.
  • Developing, optimizing and implementing robust manufacturing processes for MSCs & stem cell conditioned media products.
  • Develop vendor sourcing & management for materials supplies for production.
  • Develop a team of technical experts through on the job training or course enrolment.
  • Identifying automated technology with scientific and regulatory requirements for large scale expansion, downstream and fill and finish process.

Accomplishments:

  • Process improvement: Successful investigation and troubleshooting done for batch failures. Effectively implemented improved production and analytical processes.
  • Manufacturing technology: Effectively coordinated with multiple international companies to identify better technology for upscale and downstream processes.
  • New GMP facility: Co-ordinated for developing new cell therapy manufacturing facility layout design as per manufacturing process flow, equipment details, power and other engineering requirements.
  • Effectively managed crisis during COVID19 pandemic on critical equipment maintenance, raw material procurement, production planning and product delivery.
  • Industrial internship guidance:  
  • Project entitled ‘Development of a hydrogel dressing embedded with nanoparticles containing bone marrow derived mesenchymal stromal cell conditioned medium’ to MTECH student, Department of Biotechnology, Manipal Institute of Technology. 
  •  Study results published in ‘Stem cell research and therapy’ Journal.
  •  Project entitled ‘Large-scale expansion of mesenchymal stromal cells for therapy’ to BTECH student, Department of Biomedical Engineering, Manipal Institute of Technology.

PhD candidate: School of Integrative Engineering, Chung Ang university (March 2014 to February 2018).

Advanced biomaterials and stem cell engineering lab.

Major: Biomedical engineering program.

Research title: Development of novel therapeutic model using mesenchymal stem cells and matrilin-3 for cartilage/intervertebral disc regeneration.

Accomplishment: Successfully developed a process using an autologous MSCs for targeted hyaline cartilage and intervertebral disc regeneration (Presently IND submission process in progress)

Researcher:  Stem cell engineering lab, Department of biomedical engineering, CHA stem cell institute, CHA university (March 2014 to February 2018).

Research title: Cartilage and inetervertebral disc tissue engineering.

 

Sr. Executive: Stempeutics Research Pvt Ltd, Manipal, India (April 2013 to February 2014).

Executive: Stempeutics Research Pvt Ltd, Manipal, India (May 2010 to March 2013).

Responsibilities held

Large scale isolation and culture of adult stem cells

  • Processing of clinical grade allogeneic bone marrow derived MSCs as per GMP and ISO 9001:2008 standards.
  • Forecasting of clinical grade MSCs production.

Investigational Medicinal Product Management

  • Drug delivery: Preparation of injectable final formulation of MSCs for clinical trials.
  • Investigational medicinal product cold chain and delivery management for clinical trials.

Inventory management: Annual budget for production, Management Information System (MIS) of Investigational medicinal product and Product development, Work In Progress (WIP), large scale batch and experimental studies costing, Raw material supply chain management.

Documentation – Quality management systems, Overview and completion of batch processing records, equipment monitoring and preventive performance management records, deviation management and CAPA, change control management.

New SOP identification, preparation and amendment of SOPs.

Accomplishment: Cost reduction - maintaining a low inventory and staggered supply chain management.

 

Tutor: Department of Biochemistry, Sree Mookambika Institute of Medical Sciences, affiliated to MGR University, Kulasekharam, Tamilnadu, India. (Nov 2009 – April 2010)

Responsibilities held

  • Theory and practical classes for students of Bachelor of Medicine and bachelor of Surgery (MBBS) and Bachelor of nursing courses.
  • Incharge of Clinical biochemistry laboratory, Hospital section.

Honors and awards

  • Young scientist scholarship, Chung Ang University (March 2014- February 2017).
  • Oral presentation award, International Conference on Healthcare and Technical Research, Manipal, India, 2015.
  • Oral presentation award, International Symposium and Fall Meeting of The Korean Society of Biomaterials, 2017.

Membership

  • Tissue Engineering and Regenerative medicine Soceity– EU Chapter 2017

Creative Works

Skills

Scientific techniques

  • Next generation MSCs based product development: Innovation and optimization of priming, culture conditions, and injectable delivery system for targeted disease as per regulatory and clinical standards.
  • MSCs delivery strategies: Method standardization, characterization, validation of final formulation preparation with high stability and efficacious MSCs.
  • MSCs spheroids and hydrogel combination for delivery: A method for developing viable and efficacious models.
  • Hyaluron based hydrogel scaffold and gelatin nanofiber preparation combined with MSCs for developing implantable models.
  • Design and development of nanoparticle and biopolymer complex as implantable model for delivery of MSC derived secretome.
  • Isolation, purification, large scale expansion and banking of MSCs from bone marrow and adipose tissue.
  • Serum/xeno free media optimization for isolation and large scale expansion of MSCs.
  • Cell characterization: RT-PCR, western blot, flow cytometry, immunofluorescence, cytokine array, and cell signaling assays.
  • Cell based assays: Spheroid culture, neovascularization, direct and indirect co-culture, toxicity, proliferation, macrophage polarization.
  • Cell handling: MSCs from human bone marrow, adipose tissue, umbilical cord; human chondrocytes, human nucleus pulposus, neuronal cell line, human umbilical vein endothelial cells (HUVEC), human aortic endothelial cells (HAEC), human fibroblasts, monocytes, and macrophages.
  • Animal study: Rat and mice knee histology, immunohistochemistry, and pre-clinical grading.

 

Intellectual Property

Patents

  1. Kim B, Lee SH, Muttigi MS, Han I, Park H, Kim J. Composition and differentiation method for chondrocyte differentiation from adult stem cells. Number : 10-2016-0032031 (applied)
  2. Park H, Kim Y, Muttigi MS, Lee SH, Kim J. Composition for inducing differentiation of chondrocytes, including microparticles and cells. Number: 1020190054425 (applied).

Regulations, standards and audits

  • Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, A guidance for industry (US FDA).
  • Quality and safety assurance for drugs and medical devices manufactured using human (allogeneic) somatic stem cells, PMDA, Japan.
  • Central Drugs Standard Control organization (CDSCO) audit for Drug Product manufacturing.
  • Certificate of pharmaceutical product (CoPP), DCGI India.
  • ISO 9001:2015 Quality management system (QMS) / ISO re-certification and surveillance audit. Certified internal auditor, internal auditing as lead auditor/auditor.
  • Quality management systems (QMS) initiatives and adhering to QMS requirements.

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