The platform consists of specific hardware, represented by state-of-the art equipment for automated stem-cell culturing and

  • Determine optimum cell culture conditions for a large number of factors using different factorial matrix designs equipped with robotics and deep analytics. 
  • Develop and validate analytical methods required for release of cellular materials for human use.
  • Acquire knowledge and deliver results to support future grant applications.
  • Reduce, significantly, developmental costs and time. 
  • Develop and validate analytical methods required for cellular materials release for human use. 
  • Study report that applies QbD, DoE and MVDA fundamentals. 
  • Support preparation of IND documentation and regulatory guidance.

The X-Vivo enclosure is a modular solution replacing the more traditional cleanroomsetting. It allows for complete environmental control of cellular conditions putting the cells, rather than the scientist, first. Oxygen, carbon dioxide, humidity and temperature can be controlled on a modular or global scale to eliminate cell shock during cell culturing and processing. Manual processing chambers and built-in incubators allow for manual cell expansion. A light microscope, centrifuge and cell counter are enclosed in the system to limit exposure to non-ideal conditions during basic cell evaluation procedures. Buffer chambers allow items to be introduced into the system with minimum particulates and contaminants.

The Evo liquid handling robot along with the carousel incubator are also enclosed within the X-Vivo enclosure and allow for automated processing of a wide range of experimental parameters as defined by Design of Experiment (DoE) designs. The system is uniquely designed for optimization protocols exploring cell growth and differentiation conditions using complicated media compositions, including multi-stage differentiation. Barcode scanning allows for chain-of-custody tracking of plates and, ultimately the experimental conditions within those plates. The automated system can handle cell-culture plates ranging from six well up to high-throughput 96 well plates.

For data analysis, the QuantStudio OpenArray platform (Life Technologies) is available to provide gene expression and genotyping data. The Investigator can customize an array with up to 56 genes (three of which are internal controls) to analyze each experiment. For a typical project, minimum custom orders consist of 10 OpenArray plates, each plate testing 48 samples x 56 genes. This allows each experiment to generate 26,880 gene expression data points which are imported back into the DoE software for data analysis of experimental conditions. OH-Alive staff can provide investigators with guidance on selecting appropriate genes to meet their experimental design or designing the OpenArray plate.