The Cytologics Quality Standards
Quality Standards and consistency of biospecimens is crucial to the success of drug and diagnostic development programs. Cytologics maintains comprehensive staff training and validation of instruments & processes to ensure customers receive consistent, high-quality products. The Cytologics Quality System ("CQS") is based on strict regulatory requirements and industry best practices. The CQS spans all of our cell procurement activities, from donor qualification to packaging & shipping. We rigorously track quality indicators for continual process improvement and routinely inspect our systems for regulatory compliance.
We know there’s nothing worse than getting your experiment set up and all your cells are either dead or inadequate in number. Such quality issues cause lost time and added expense to your laboratory. When you procure products from Cytologics, you can rest assured that cells are stringently controlled and are accurately labeled in terms of type, viability and quantity. Also, as stewards of the scientific research community, we are committed to operating under the highest ethical and legal standards in the acquisition of human specimens used for the isolation of primary cells and other biological materials.
Ethics and Informed Consent
Cytologics complies with all applicable local, state, and federal laws and regulations. Cells are obtained from donors who are appropriately consent for research at a FDA-registered blood collection center. Biological material is collected and processed following AABB guidelines. All specimens are shipped, used, stored, and destroyed in compliance with all applicable local, state, and federal laws and regulations.
Cytologics supports the discovery and development of therapies and diagnostics. To ensure product integrity is maintained, all critical processes are defined in approved operational procedures. Our team of experts are qualified, trained, and apply the operational excellence needed to ensure the highest quality product possible.
Cytologics's state-of-the-art facility expedites the collection and processing of cells and other human biological material. All laboratories operate in a high efficiency particulate air filtration environment designed for cell processing, storage, and subsequent transport to our customers. The facility has been equipped with redundant systems including back-up electrical generators to ensure continuous power for freezers and 24/7 controlled access to ensure security.
Licensing and Accreditation
Cytologics complies with laws and regulations governing the sourcing, handling, processing, storage, preserving, packaging, and distribution of products. All partner donor collection centers in the Cytologics network are FDA registered and meet all applicable GMP/GTP standards (21 CFR 210, 211, 606, 1271 and 21 CFR part 11 and part 58).