iPS Cell Banking

Induced pluripotent stem cell (iPSC) banking is one of the major efforts to provide a valuable resource for the research community, which provides an unprecedented opportunity to study the cell types from patients that are affected by the disease but cannot otherwise be easily obtained in large quantities from them.

iPS cells are generated from cells easily obtained from living humans, such as blood or a small piece of skin; they have unlimited expansion potential in the petri dish, so huge numbers of cells can be generated for research studies or drug development; and they can be coaxed into the types of cells affected in various diseases, such as heart or brain disorders.

Creative Bioarray provides a cGMP-compliant iPS stem cell bank by following the industry-standard cell bank system to help our customers worldwide. From one clone, we will manufacture a cGMP master cell bank (MCB) and working cell banks (WCB) that are compliant with the current standards outlined by the key regulatory agencies. We are committed to advancing your project by providing all necessary quality and regulatory documents.

Our Cell Services Cover the Complete Lifecycle of a Cell Bank

• Different demographic backgrounds available (age, ethnicity, gender).
• Donor eligibility requirements for regulatory compliance (screening, viral testing).
• iPS stem cell culture, identification, and biosafety testing.
• Follow governmental regulations in fibroblasts to iPSC seed stock process.
• Cell banking for master cell banks under cGMP conditions.
• Cell banking for working cell banks under cGMP conditions.
• Complete validation and release of MCB and WCB in compliance with national regulatory requirements.
• Long-term storage of cell banks under cGMP management with a reasonable amount of inventory and freezing stability guarantee.

Fig.1 Various cell sources and delivery methods for generating iPS cells. (Han JW and Yoon YS, 2011)

Our Service Lists

• Facilities in accordance with cGMP requirements. For clinical applications and drug development, pluripotent cell lines that are not exposed to animal-derived material and heterologous genes are a requirement (cGMP level).
• Our scientists will generate your clinical-grade stem cells using sophisticated RNA reprogramming technology. This footprint-free reprogramming technique allows you access to the consistency, safety, and quality needed for demanding therapeutic projects.
• Strict quality control of cell banks is performed at the first level of quality control by confirming the characteristics and purity of cell lines, the second level is cell performance and stability, and the third level is cell product characterization.
• Our iPSC experts will provide the necessary quality and regulatory documents such as COA, batch records, and quality technical agreements for your cGMP iPSC cell banks.

Creative Bioarray provides cost-effective, high-quality, and hassle-free services to our customers worldwide. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.