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IntroductionCurrent production facilities for Cell-Based Health care Products (CBHPs), also referred as Advanced-Therapy Medicinal Products or Regenerative Medicine Products, are still dependent on manual work performed by skilled workers. A more robust, safer and efficient manufacturing system will be necessary to meet the expected expansion of this industrial field in the future. Thus, the ‘flexible Modular Platform (fMP)’ was newly designed to be a true “factory” utilizing the state-of-the-art technology to replace conventional “laboratory-like” manufacturing methods. Then, we built the Tissue Factory as the first actual entity of the fMP.MethodsThe Tissue Factory was designed based on the fMP in which several automated modules are combined to perform various culture processes. Each module has a biologically sealed chamber that can be decontaminated by hydrogen peroxide. The asepticity of the processing environment was tested according to a pharmaceutical sterility method. Then, three procedures, production of multi-layered skeletal myoblast sheets, expansion of human articular chondrocytes and passage culture of human induced pluripotent stem cells, were conducted by the system to confirm its ability to manufacture CHBPs.ResultsFalling or adhered microorganisms were not detected either just after decontamination or during the cell culture processes. In cell culture tests, multi-layered skeletal myoblast sheets were successfully manufactured using the method optimized for automatic processing. In addition, human articular chondrocytes and human induced-pluripotent stem cells could be propagated through three passages by the system at a yield comparable to manual operations.ConclusionsThe Tissue Factory, based on the fMP, successfully reproduced three tentative manufacturing processes of CBHPs without any microbial contamination. The platform will improve the manufacturability in terms of lower production cost, improved quality variance and reduced contamination risks. Moreover, its flexibility has the potential to adapt to the modern challenges in the business environment including employment issues, low operational rates, and relocation of facilities. The fMP is expected to become the standard design basis of future manufacturing facilities for CBHPs.

The spectra of trebly ionized tantalum and quadruply ionized tungsten were photographed in the 300A-1220A region on a 3-m normal incidence spectrograph at the Antigonish laboratory using a triggered spark and a sliding spark source. The earlier analyses of the (5dZ + 5d6s)-(5d6p + 6s6p)transitions have been confirmed. The analyses of the 5d2-5d5f transitions of Ta IV and W V have resulted in classifying 49 lines in each of these spectra. Out of the 20 possible levels of the 5d5f configuration 16 levels in Ta IV and 17 levels in W V have been established. The least-squares-fitting (LSF) and Hartree-Fock (HF) configuration interaction calculations were carried out and they interpret both spectra satisfactorily. The energy parameters and the scaling factors have been compared in the isoelectronic sequence from Ta IV to Ir VI11 and they show smooth variations.

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