Manufacturing

Manufacturing

Cell Culturing and Cell Banks

Our Cell Banks are the foundation for our cell-based technologies. 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.

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 quickly 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.

Extensive in vitro and in vivo testing are 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 our own rigorous internal testing, each master cell bank is reviewed and approved by the FDA prior to its use in manufacturing.

Cellular Product Advanced Manufacturing Systems

To support our growing sales and as part of our commitment to advance the science of manufacturing, the company has developed an automated closed bio-reactor system for the culturing of Apligraf®. At the center of this new system is a unique state-of-the-art culture tray utilizing self-sealing septa and vented ports, designed to provide a protective barrier between Apligraf® and the environment.

A custom designed automated system has been developed to perform the culturing activities in a controlled and highly reproducible manner. This new culturing system is in the final stages of development and will be rolled out in the near future.