Our Quality Systems have been designed to align with EU regulatory standards for cell therapy products, and we are actively working towards meeting US regulatory standards as well. These systems provide the necessary flexibility to support both clinical and commercial manufacturing processes.
Our quality control testing facilities hold cGMP accreditation and are fully equipped to qualify and validate analytical methods required to demonstrate the identity, safety, stability, purity, and in-vitro potency of your cell-based products.
Cell Easy’s Quality Team possesses the following key attributes:
- A proven track record of successfully hosting third-party audits.
- Comprehensive capabilities in quality control analytics.
- Cell isolation, cell sorting, cell expansion, washing, volume reduction, and buffer manufacturing.
Quality Control: The QC team collaborates closely with the Analytical Development team to facilitate method transfer, optimization, qualification, and validation processes.
Our QC laboratories are strategically located adjacent to the manufacturing suites, enabling swift transfer of product samples for analysis.
Our capabilities encompass:
- Testing of starting materials, in-process samples, and final product samples.
- Core chemistry, analytical, and microbiological analyses (e.g., compendial analysis, ELISA, rapid sterility testing, microbial identification, spectroscopy).
- Conducting stability studies, managing reference standards and controls, and coordinating outsourced characterization testing.
- Environmental, personnel, and utility monitoring.
