Quality Assurance

Quality Management Expertise

Chandresh Undhad, M.S.


  • Successful manufacturing process and analytical method transfer, implementation and regulatory support for 30+ pre-IND to Phase III biologics and cell therapy clinical products leading to the advancement of multiple commercial products.
  • Process and analytical method development, validation and routine performance to support recombinant proteins and cell/gene therapy products. Management of domestic and international external GMP contract manufacturing and testing facilities.
  • Design, implementation and management of GMP and Part 11 compliant quality systems in start-up and commercial environments establishing deviation, investigation, corrective/preventive action, document control, training, raw materials, supply chain, asset and vendor management.
  • Design, commissioning and operation of multiple GMP manufacturing and analytical laboratory facilities from greenfield builds to remodels, ranging from 5,000 ft2 to 50,000 ft2.
  • Operations and Manufacturing
    • Supply Chain/Materials Management
    • Drug Substance and Drug Product Contract Manufacturing
    • Recombinant protein and cell therapy process development
    • Technology transfer
    • Process monitoring and improvement
    • Facility design
  • Quality Assurance with the following products
    • Injectable biologics
    • Allogeneic/autologous gene and cellular therapeutics
    • Laboratory design/process and assay transfer
  • Validation
    • Analytical methods
    • Equipment
    • Facilities/Utilities
    • Computer Systems/Part 11 Compliance

Quality Management System (QMS)

  • Dedicated Quality Assurance staff
  • Q-Pulse – Electronic Quality Management System (EQMS)
    • Supplier qualification and management
    • Personnel management
    • Asset management (maintenance and calibration)
    • Real-time trending and analysis
    • Document Control
    • Real-time equipment monitoring
  • Provide oversight of all manufacturing and facility operations through a comprehensive quality management system tailored to meet regulatory requirements for protein-based biologics and cell-based products
  • Strategic development of QMS in technical areas based on customer type and product requirements.
  • Material tracking software utilizing barcodes
  • Environmental monitoring trending software

Quality Control Laboratory

  • State-of-the-art, qualified equipment for environmental and product testing
  • Dedicated quality control staff experienced in cellular and protein analytical techniques

Quality Control Laboratory

Cell Processing
  • Real-time thermocycler
    • Gene expression
    • Mycoplasma
  • Flow cytometry – ten colors, three lasers
  • Automated cell counter – trypan blue, fluorescent dye compatible
  • Microscopy – brightfield, phase, fluorescence
  • Microplate reader with high-content cell imaging
  • Cell-based assays
Protein Manufacturing
  • HPLC/UPLC systems
  • UV-Vis spectroscopy
  • ELISA and cell-based assays
  • Real-time thermocycler
  • Residual host cell DNA
  • Biophysical and mass spectrometer characterization using CU Anschutz Medical Campus core facilities
  • Dedicated microbiologists
  • Endotoxin testing
  • Bioburden testing
  • Mycoplasma testing
  • Sterility testing
  • Microbial air sampling
  • Non-viable particle analyzers