Quality Assurance
- 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
- 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
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
- ELISA
- Cell-based assays
Protein Manufacturing
- HPLC/UPLC systems
- UV-Vis spectroscopy
- SDS-PAGE
- ELISA and cell-based assays
- Real-time thermocycler
- Residual host cell DNA
- Biophysical and mass spectrometer characterization using CU Anschutz Medical Campus core facilities
Microbiology
- Dedicated microbiologists
- Endotoxin testing
- Bioburden testing
- Mycoplasma testing
- Sterility testing
- Microbial air sampling
- Non-viable particle analyzers