GMP-Compliant Clean Laboratory for Cell and Gene Therapy – Tailored for cutting-edge biopharmaceutical R&D and production scenarios, including CAR-T cell therapy, stem cell therapy, and gene-editing therapy, this solution provides GMP-compliant dedicated clean laboratory facilities for cell and gene therapy, fully meeting the requirements across the entire process flow: cell isolation, culture, expansion, formulation preparation, and storage. The facility is meticulously designed in accordance with B+A clean classification standards, with core operational zones achieving dynamic Class 100 cleanroom control. It is equipped with an independent personnel changing system, material disinfection system, and cell handling isolation system. All environmental surfaces in contact with cells utilize non-toxic, non-leachable, and easily sterilizable medical-grade materials, thereby completely eliminating the risk of exogenous contamination affecting cell product quality. The enclosure system features modular stainless steel cleanroom wall panels, with all seams fabricated via automated welding and polished surfaces; the overall airtightness meets Class I standards, enabling regular sterilization under diverse disinfection protocols. The purified air conditioning system employs a fresh-air direct-flow design, integrated with HEPA filtration units and activated carbon adsorption modules, ensuring that the delivered air meets stringent cell culture environment requirements while enabling precise pressure gradient control to rigorously prevent cross-contamination. The ancillary areas—liquid nitrogen storage zone, quality control zone, and finished product refrigeration zone—each incorporate independent pressure control and environmental monitoring systems, ensuring full traceability of environmental parameters throughout the entire process. The overall system design integrates the concept of single-use process equipment compatibility, featuring ample equipment interfaces and pipeline channels to flexibly accommodate the installation and operation of high-end equipment, including biosafety cabinets, cell culture incubators, flow cytometers, and fully automated cell preparation systems. The integrated intelligent GMP environment management system enables automated collection and electronic archiving of environmental parameters, disinfection records, and equipment operation data, fully complying with regulatory traceability requirements for cell therapy product manufacturing. This system empowers biopharmaceutical enterprises to safely conduct research, development, and commercialization of cutting-edge cell and gene therapy technologies, while providing reliable hardware support for the deployment of next-generation precision therapy technologies.
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