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A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

ABSTRACT: Introduction:Current 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. Methods:The 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. Results:Falling 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. Conclusions:The 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.

SUBMITTER: Kikuchi T

PROVIDER: S-EPMC6223031 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

Kikuchi Tetsutaro T Kino-Oka Masahiro M Wada Masanori M Kobayashi Toyoshige T Kato Midori M Takeda Shizu S Kubo Hirotsugu H Ogawa Tetsuya T Sunayama Hironobu H Tanimoto Kazuhito K Mizutani Manabu M Shimizu Tatsuya T Okano Teruo T

Regenerative therapy 20180919

<h4>Introduction</h4>Current 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- ...[more]

PMID: 30525079

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Project description:BACKGROUND:Strong primary health care (PHC) is essential for achieving universal health coverage, but in many low- and middle-income countries (LMICs) PHC services are of poor quality. Facility management is hypothesized to be critical for improving PHC performance, but evidence about management performance and its associations with PHC in LMICs remains limited. METHODS:We quantified management performance of PHC facilities in Ghana and assessed the experiences of women who sought care at sampled facilities. Using multi-level models, we examined associations of facility management with five process outcomes and eight experiential outcomes. FINDINGS:On a scale of 0 to 1, the average overall management score in Ghana was 0·76 (IQR = 0·68-0·85). Facility management was significantly associated with one process outcome and three experiential outcomes. Controlling for facility characteristics, facilities with management scores at the 90th percentile (management score = 0·90) had 22% more essential drugs compared to facilities with management scores at the 10th percentile (0·60) (p = 0·002). Positive statistically non-significant associations were also seen with three additional process outcomes-integration of family planning services (p = 0·054), family planning types provided (p = 0·067), and essential equipment availability (p = 0·104). Compared to women who sought care at facilities with management scores at the 10th percentile, women who sought care at facilities at the 90th percentile reported 8% higher ratings of trust in providers (p = 0·028), 15% higher ratings of ease of following provider's advice (p = 0·030), and 16% higher quality rating (p = 0·020). However, women who sought care in the 90th percentile facilities rated their waiting times as worse (22% lower, p = 0·039). INTERPRETATION:Higher management scores were associated with higher scores for some process and experiential outcomes. Large variations in management performance indicate the need to strengthen management practices to help realize the full potential of PHC in improving health outcomes.

Dataset Information

A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

Publications

A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

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