To complement our Clinic’s on site Clinical Lab and Pharmacy, our HAL research facilities are fully equipped with a diverse array of instruments for cell enrichment, analysis, expansion & culture, and sample preservation. BioCytics staff will work with each sponsor to ensure your protocol, assays, and preclinical product are developed on the platform of your choosing. All devices are user-configurable and our staff scientists, cell processing specialists, and research team will develop a custom plan for your research needs.
Our cleanroom facility is designed to provide flexible space for the development and manufacturing of your cell therapy product(s). It is comprised of three large ISO-7 cleanrooms and two medium ISO-7 cleanrooms, the latter are capable of positive or negative pressures depending on need. These units are built around a central ISO-8 hallway connecting the spaces via a dedicated anteroom and gowning area.
The cleanroom facility is designed with architectural features and finishes in accordance with US FDA regulations as well as international standards for controlled cleanroom manufacturing environments and aseptic processing.
In addition to the cleanrooms, the facilities contain separate USP797 and USP800 pharmacy suites, a dedicated shipping and receiving area, and a large, contiguous GLP lab adjacent to the cleanrooms.
- Floors and other exposed surfaces are designed to withstand the necessary cleaning and sanitization that ensure product purity and patient safety
- HEPA filter and air-handling units are configured to deliver particulate-free air; the air quality meets Class 10,000 (ISO class 7) standards
- Segregated HVAC equipment are built from best of breed equipment
- Critical parameters (temperature, pressure, and humidity) are continually monitored
- Environmental remote temperature monitoring performed by FDA-compliant Sonicu systems
- Standard operating procedures assure that all systems are properly maintained and functional
- Access to the facility is keycard controlled
