Cellular Technology

Cell Bank Development

Our Cell Banks are the foundation for our cell-based technologies. The process for generating cell banks to meet our rigorous manufacturing requirements is a multi-stepped process that can take several years to complete. It all begins with procuring the donor tissue.

We partner with hospitals and physicians to identify appropriate donor candidates. Once a donor is identified and agrees to participate, an extensive series of tests are performed to ensure the safety of the donated tissue.

The donated tissue is transported via courier to our manufacturing facility where it is dissociated into either human keratinocytes or human dermal fibroblasts. This dissociation occurs within 24 hours after harvesting the tissue in order to ensure optimal cell function. The cells are then expanded over the course of several weeks, eventually becoming master and working cell banks.

In order to meet our manufacturing needs we have developed advanced methods for producing and manufacturing scale cell cultures and cell banks of both human keratinocytes and human dermal fibroblasts. Our methods are highly reproducible and result in cells that are extremely consistent in their phenotype.

Extensive in vitro and in vivo testing is performed to analyze the biochemical and functional characteristics of the cell lines prior to use in manufacturing. This testing is done to demonstrate bio-equivalence between cell lines and ensure quality products.

In addition to the work to support our manufacturing process we have several ongoing research initiatives looking into advancing our cell culture current technologies as well as developing new cell based products.