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Article ; Online: Country-specific regulation and international standardization of cell-based therapeutic products derived from pluripotent stem cells.

Hirai, Takamasa / Yasuda, Satoshi / Umezawa, Akihiro / Sato, Yoji

2023 Volume 18, Issue 8, Page(s) 1573–1591

Abstract: Currently, many types of cell-based therapeutic products (CTPs) derived from pluripotent stem cells (PSCs) are being developed in a lot of countries, some of which are in clinical trial stages. CTPs are classified differently in different countries and ... ...

Abstract	Currently, many types of cell-based therapeutic products (CTPs) derived from pluripotent stem cells (PSCs) are being developed in a lot of countries, some of which are in clinical trial stages. CTPs are classified differently in different countries and regions. The evaluation of their efficacy, safety, and quality also differs from that for conventional small-molecule drugs and biopharmaceuticals, which reflects the complex properties of living cells and unmet medical needs. Since there are no international guidelines to evaluate CTPs, including PSC-derived products, it is necessary to be aware of differences in relevant laws and regulations in different countries and regions. International consortia are organized and actively working to standardize/harmonize the evaluation methods and regulations to facilitate the development and global distribution of PSC-derived CTPs. In this paper, we outline the regulations related to PSC-derived CTPs in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use founding regions (US, EU/UK, Japan) and introduce representative consortia working on their standardization.
MeSH term(s)	Humans ; Pluripotent Stem Cells ; Japan ; Reference Standards
Language	English
Publishing date	2023-08-07
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2720528-9
ISSN	2213-6711 ; 2213-6711
ISSN (online)	2213-6711
ISSN	2213-6711
DOI	10.1016/j.stemcr.2023.05.003
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

Sato, Yoji

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo hokoku = Bulletin of National Institute of Health Sciences

2014 , Issue 132, Page(s) 6–9

Abstract: In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the ... ...

Abstract	In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Genetic Therapy ; Government Agencies ; Health Services Administration ; Japan ; Regenerative Medicine ; Translational Medical Research
Language	Japanese
Publishing date	2014
Publishing country	Japan
Document type	English Abstract ; Journal Article ; Review
ZDB-ID	1436046-9
ISSN	1343-4292
ISSN	1343-4292
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Zs.B 1285: Show issues

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Article ; Online: A simple method to estimate the in-house limit of detection for genetic mutations with low allele frequencies in whole-exome sequencing analysis by next-generation sequencing.

Miura, Takumi / Yasuda, Satoshi / Sato, Yoji

BMC genomic data

2021 Volume 22, Issue 1, Page(s) 8

Abstract: Background: Next-generation sequencing (NGS) has profoundly changed the approach to genetic/genomic research. Particularly, the clinical utility of NGS in detecting mutations associated with disease risk has contributed to the development of effective ... ...

Abstract	Background: Next-generation sequencing (NGS) has profoundly changed the approach to genetic/genomic research. Particularly, the clinical utility of NGS in detecting mutations associated with disease risk has contributed to the development of effective therapeutic strategies. Recently, comprehensive analysis of somatic genetic mutations by NGS has also been used as a new approach for controlling the quality of cell substrates for manufacturing biopharmaceuticals. However, the quality evaluation of cell substrates by NGS largely depends on the limit of detection (LOD) for rare somatic mutations. The purpose of this study was to develop a simple method for evaluating the ability of whole-exome sequencing (WES) by NGS to detect mutations with low allele frequency. To estimate the LOD of WES for low-frequency somatic mutations, we repeatedly and independently performed WES of a reference genomic DNA using the same NGS platform and assay design. LOD was defined as the allele frequency with a relative standard deviation (RSD) value of 30% and was estimated by a moving average curve of the relation between RSD and allele frequency. Results: Allele frequencies of 20 mutations in the reference material that had been pre-validated by droplet digital PCR (ddPCR) were obtained from 5, 15, 30, or 40 G base pair (Gbp) sequencing data per run. There was a significant association between the allele frequencies measured by WES and those pre-validated by ddPCR, whose p-value decreased as the sequencing data size increased. By this method, the LOD of allele frequency in WES with the sequencing data of 15 Gbp or more was estimated to be between 5 and 10%. Conclusions: For properly interpreting the WES data of somatic genetic mutations, it is necessary to have a cutoff threshold of low allele frequencies. The in-house LOD estimated by the simple method shown in this study provides a rationale for setting the cutoff.
MeSH term(s)	DNA Mutational Analysis/methods ; DNA Mutational Analysis/standards ; Gene Frequency ; High-Throughput Nucleotide Sequencing ; Humans ; Limit of Detection ; Mutation ; Whole Exome Sequencing
Language	English
Publishing date	2021-02-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2730-6844
ISSN (online)	2730-6844
DOI	10.1186/s12863-020-00956-x
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Article ; Online: [In vitro tumorigenicity tests for process control of health care products derived from human induced pluripotent stem cells].

Sato, Yoji

Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan

2013 Volume 133, Issue 12, Page(s) 1381–1388

Abstract: The goal of pharmaceutical sciences is to deliver effective and safe medicinal products to patients. To achieve this goal, we need to ensure the efficacy, safety and quality of the products. Currently, many attempts are made to utilize human induced ... ...

Abstract	The goal of pharmaceutical sciences is to deliver effective and safe medicinal products to patients. To achieve this goal, we need to ensure the efficacy, safety and quality of the products. Currently, many attempts are made to utilize human induced pluripotent stem cells (hiPSCs) in regenerative medicine/cell therapy. There are significant obstacles, however, preventing the clinical use of hiPSC-derived products. One of the most obvious safety issues is the presence of residual undifferentiated cells that have tumorigenic potential. Therefore, the assessment and control of the tumorigenicity of hiPSC-derived products is essential in order to prevent tumor development by residual pluripotent stem cells after implantation. We recently examined three in vitro assay methods to detect undifferentiated cells: soft agar colony formation assay, flow cytometry assay and quantitative real-time polymerase chain reaction assay (qRT-PCR). Although the soft agar colony formation assay was unable to detect hiPSCs, the flow cytometry assay using anti-TRA-1-60 antibody detected 0.1% undifferentiated hiPSCs that were spiked in primary retinal pigment epithelial (RPE) cells. Moreover, qRT-PCR with a specific probe and primers was found to detect a trace amount of LIN28 mRNA, which is equivalent to that present in a mixture of a single hiPSC and 5.0×10(4) RPE cells. Our findings provide highly sensitive and quantitative in vitro assays essential for facilitating safety profiling of hiPSC-derived RPE cells for their clinical use.
MeSH term(s)	Cell Transformation, Neoplastic ; Gene Expression Regulation, Neoplastic ; Guidelines as Topic ; Humans ; Induced Pluripotent Stem Cells/cytology ; Induced Pluripotent Stem Cells/metabolism ; RNA, Messenger/genetics ; RNA-Binding Proteins/genetics
Chemical Substances	Lin28A protein, human ; RNA, Messenger ; RNA-Binding Proteins
Language	Japanese
Publishing date	2013-11-28
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	200514-1
ISSN	1347-5231 ; 0031-6903 ; 0372-7750 ; 0919-2085 ; 0919-2131
ISSN (online)	1347-5231
ISSN	0031-6903 ; 0372-7750 ; 0919-2085 ; 0919-2131
DOI	10.1248/yakushi.13-00232-3
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Zs.A 643: Show issues

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Article: Mechanical Characterization of Dissolving Microneedles: Factors Affecting Physical Strength of Needles.

Ando, Daisuke / Miyatsuji, Megumi / Sakoda, Hideyuki / Yamamoto, Eiichi / Miyazaki, Tamaki / Koide, Tatsuo / Sato, Yoji / Izutsu, Ken-Ichi

Pharmaceutics

2024 Volume 16, Issue 2

Abstract: Dissolving microneedles (MNs) are novel transdermal drug delivery systems that can be painlessly self-administered. This study investigated the effects of experimental conditions on the mechanical characterization of dissolving MNs for quality evaluation. ...

Abstract	Dissolving microneedles (MNs) are novel transdermal drug delivery systems that can be painlessly self-administered. This study investigated the effects of experimental conditions on the mechanical characterization of dissolving MNs for quality evaluation. Micromolding was used to fabricate polyvinyl alcohol (PVA)-based dissolving MN patches with eight different cone-shaped geometries. Axial force mechanical characterization test conditions, in terms of compression speed and the number of compression needles per test, significantly affected the needle fracture force of dissolving MNs. Characterization using selected test conditions clearly showed differences in the needle fracture force of dissolving MNs prepared under various conditions. PVA-based MNs were divided into two groups that showed buckling and unbuckling deformation, which occurred at aspect ratios (needle height/base diameter) of 2.8 and 1.8, respectively. The needle fracture force of PVA-based MNs was negatively correlated with an increase in the needle's aspect ratio. Higher residual water or higher loading of lidocaine hydrochloride significantly decreased the needle fracture force. Therefore, setting appropriate methods and parameters for characterizing the mechanical properties of dissolving MNs should contribute to the development and supply of appropriate products.
Language	English
Publishing date	2024-01-30
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics16020200
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Article ; Online: Correction: Effects of Apex Size on Dissolution Profiles in the USP II Paddle Apparatus.

Yoshida, Hiroyuki / Morita, Tokio / Abe, Yasuhiro / Inagaki, Aoi / Tomita, Naomi / Izutsu, Ken-Ichi / Sato, Yoji

AAPS PharmSciTech

2024 Volume 25, Issue 3, Page(s) 48

Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2052070-0
ISSN	1530-9932 ; 1530-9932
ISSN (online)	1530-9932
ISSN	1530-9932
DOI	10.1208/s12249-024-02770-5
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Article ; Online: Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products.

Hirai, Takamasa / Kataoka, Kiyoko / Yuan, Yuzhe / Yusa, Keisuke / Sato, Yoji / Uchida, Kazuhisa / Kono, Ken

Biologicals : journal of the International Association of Biological Standardization

2023 Volume 85, Page(s) 101739

Abstract: Next-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft ... ...

Abstract	Next-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to in vitro viral tests. To examine the performance of NGS for the in vitro detection of viruses, adenovirus type 5 (Ad5), a model virus, was inoculated into Vero cells, which are the most popular indicator cells for the detection of adventitious viruses in the in vitro test. Total RNA extracted from the Vero cells infected with Ad5 was serially diluted with that from non-infected Vero cells, and each sample was analyzed using short- or long-read NGSs. The limits of detection of both NGS methods were almost the same and both methods were sensitive enough to detect viral sequences as long as there was at least one copy in one assay. Although the multiplexing in NGS carries the risk of cross-contamination among the samples, which could lead to false positives, this technology has the potential to become a rapid and sensitive method for detecting adventitious agents in biologics.
MeSH term(s)	Animals ; Chlorocebus aethiops ; Biological Products ; Vero Cells ; Viruses/genetics ; Adenoviridae/genetics ; High-Throughput Nucleotide Sequencing/methods
Chemical Substances	Biological Products
Language	English
Publishing date	2023-12-15
Publishing country	England
Document type	Journal Article
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2023.101739
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Zs.A 879: Show issues

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Article: A simple method to estimate the in-house limit of detection for genetic mutations with low allele frequencies in whole-exome sequencing analysis by next-generation sequencing

Miura, Takumi / Yasuda, Satoshi / Sato, Yoji

BMC genomic data. 2021 Dec., v. 22, no. 1

2021

Abstract: BACKGROUND: Next-generation sequencing (NGS) has profoundly changed the approach to genetic/genomic research. Particularly, the clinical utility of NGS in detecting mutations associated with disease risk has contributed to the development of effective ... ...

Abstract	BACKGROUND: Next-generation sequencing (NGS) has profoundly changed the approach to genetic/genomic research. Particularly, the clinical utility of NGS in detecting mutations associated with disease risk has contributed to the development of effective therapeutic strategies. Recently, comprehensive analysis of somatic genetic mutations by NGS has also been used as a new approach for controlling the quality of cell substrates for manufacturing biopharmaceuticals. However, the quality evaluation of cell substrates by NGS largely depends on the limit of detection (LOD) for rare somatic mutations. The purpose of this study was to develop a simple method for evaluating the ability of whole-exome sequencing (WES) by NGS to detect mutations with low allele frequency. To estimate the LOD of WES for low-frequency somatic mutations, we repeatedly and independently performed WES of a reference genomic DNA using the same NGS platform and assay design. LOD was defined as the allele frequency with a relative standard deviation (RSD) value of 30% and was estimated by a moving average curve of the relation between RSD and allele frequency. RESULTS: Allele frequencies of 20 mutations in the reference material that had been pre-validated by droplet digital PCR (ddPCR) were obtained from 5, 15, 30, or 40 G base pair (Gbp) sequencing data per run. There was a significant association between the allele frequencies measured by WES and those pre-validated by ddPCR, whose p-value decreased as the sequencing data size increased. By this method, the LOD of allele frequency in WES with the sequencing data of 15 Gbp or more was estimated to be between 5 and 10%. CONCLUSIONS: For properly interpreting the WES data of somatic genetic mutations, it is necessary to have a cutoff threshold of low allele frequencies. The in-house LOD estimated by the simple method shown in this study provides a rationale for setting the cutoff.
Keywords	DNA ; alleles ; biopharmaceuticals ; detection limit ; droplets ; gene frequency ; genomics ; risk ; standard deviation ; therapeutics
Language	English
Dates of publication	2021-12
Size	p. 8.
Publishing place	BioMed Central
Document type	Article
ISSN	2730-6844
DOI	10.1186/s12863-020-00956-x
Database	NAL-Catalogue (AGRICOLA)

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Article: [Current status of the regulation and development of cell therapy products in Japan].

Igarashi, Yuka / Sato, Yoji

Nihon yakurigaku zasshi. Folia pharmacologica Japonica

2018 Volume 151, Issue 6, Page(s) 254–259

Abstract: Ten years have passed since Yamanaka et al. reported the establishment of human iPS cells, which became one of the triggers to make national efforts in Japan to promote research and translation of regenerative medicine and cell therapy (regenerative ... ...

Abstract	Ten years have passed since Yamanaka et al. reported the establishment of human iPS cells, which became one of the triggers to make national efforts in Japan to promote research and translation of regenerative medicine and cell therapy (regenerative medicine etc.). However, it has been unreasonable in many cases to directly apply the existing regulation to cells processed for the purpose of use in regenerative medicine etc., which have quite different properties from conventional pharmaceuticals and medical devices. For this reason, in recent years, drastic reforms of various regulations of medical and pharmaceutical affairs have been vigorously pursued for efficient translation of regenerative medicine etc. Regarding medical affairs, "The Act on the Safety of Regenerative Medicine" was established for the purpose of providing safe regenerative medicine etc. to patients promptly and smoothly, establishing standards for regenerative medicine providing agencies and cell culture processing facilities. Regarding pharmaceutical affairs, a new chapter and an early approval system (conditional/term-limited approval system) for "regenerative medical products", which consists of cellular and gene therapy products, were introduced into "Pharmaceuticals and Medical Devices Act", a revised and renamed version of "Pharmaceutical Affairs Law". In this review article, we overview the current perspectives of regulations and challenges for translation of regenerative medicine etc. in Japan.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Genetic Therapy ; Humans ; Induced Pluripotent Stem Cells ; Japan ; Regenerative Medicine
Language	Japanese
Publishing date	2018-06-11
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	1097532-9
ISSN	1347-8397 ; 0015-5691
ISSN (online)	1347-8397
ISSN	0015-5691
DOI	10.1254/fpj.151.254
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Zs.A 439: Show issues

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Article ; Online: Effects of Apex Size on Dissolution Profiles in the USP II Paddle Apparatus.

Yoshida, Hiroyuki / Morita, Tokio / Abe, Yasuhiro / Inagaki, Aoi / Tomita, Naomi / Izutsu, Ken-Ichi / Sato, Yoji

AAPS PharmSciTech

2023 Volume 25, Issue 1, Page(s) 9

Abstract: The use of apex vessels may solve coning problems associated with dissolution testing. However, excessive dissolution acceleration can reduce the discriminatory power. This study aimed to clarify how different apex vessel sizes affect the dissolution ... ...

Abstract	The use of apex vessels may solve coning problems associated with dissolution testing. However, excessive dissolution acceleration can reduce the discriminatory power. This study aimed to clarify how different apex vessel sizes affect the dissolution behavior of cone-forming formulations. Five apex vessels with different heights, centralities, and compendial vessels were used. The paddle rotation speed at which the coning phenomenon resolved was measured using standard particles of different densities. Three model formulations-USP prednisone tablets, atorvastatin calcium hydrate tablets, and levofloxacin fine granules-were selected, and dissolution tests were conducted at 30-100 revolutions per minute (rpm). Compared to the compendial vessels, the disappearance of standard particles at the apex base at lower paddle speeds in apex vessels was observed. Standard particles tended to remain in the center of the apex vessels and disappear at rotational speeds comparable to those of the compendial vessels. Dissolution increased in an apex height-dependent manner in the model formulations, except for the atorvastatin calcium hydrate tablets at 50 rpm. For levofloxacin fine granules, dissolution was also improved by reducing the paddle agitation speed to 30 rpm in the compendial vessels. Differences in apex centrality by 3 mm did not affect the dissolution rate. Our results indicate that apex vessels with low apex heights have a mount-resolving effect, but the degree of dissolution improvement by avoiding the coning phenomenon depends on the formulation characteristics used in the dissolution tests.
MeSH term(s)	Solubility ; Atorvastatin ; Levofloxacin ; Tablets
Chemical Substances	Atorvastatin (A0JWA85V8F) ; Levofloxacin (6GNT3Y5LMF) ; Tablets
Language	English
Publishing date	2023-12-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	2052070-0
ISSN	1530-9932 ; 1530-9932
ISSN (online)	1530-9932
ISSN	1530-9932
DOI	10.1208/s12249-023-02722-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

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