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Rapid, affordable organ replication

• Objective

  Currently, the in vitro fabrication of human tissue structures is a labor-intensive process carried out under manual conditions. This limited scalability precludes a sufficient availability of inexpensive tissue engineered products used for transplants and in vitro testing of diverse substances. Because of rapidly increasing demand from diverse industries, our group has pursued the development, ramp-up, and commercialization of a production system to automate growing non-vascular, three-dimensional in vitro skin test models. The new system will increase throughput by one order of magnitude and decrease unit production costs by one-third. The tissue factory provides a powerful platform for novel product, process and material technologies for the automated manufacturing of various kinds of human tissues.

• Methodology

  We are leading a research consortium to examine biological and production issues relevant to automated, parallelized human tissue growth. Current manual processes must be aligned and re-engineered to comply with GMP and automation standards. Furthermore, individual components must then be designed and constructed. Novel manufacturing technologies, such as micro-machining, are also being adapted for biological application. Finally, separate process steps must be integrated to create a fully functional system. We are further in charge of defining the commercialization strategy for the system and its diverse variants.

• Results

  • Process engineering with GMP and automation constraints
  • Mass production of microstructured, biofunctional substrate surfaces for enhanced isolation, selective enrichment, and proliferation of cells, such as keratinocytes and fibroblasts
  • Development of stand-alone process modules (i.e. bioreactors for controlled cell isolation and expansion, skin model growth, online process control units, sluices)
  • Design of novel cell handling techniques
  • Ramp-up and demonstration of a stable mass production process
  • Process chain optimization and target costing
  • Market surveys for specification of customer requirements (i.e. order patterns, tolerated delivery times, required product variants)
  • Product commercialization (i.e. configuration of variants and service spectrum, elaboration of licensing models)

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