Article
Biochemical Research Methods
Kristi Budzinski, David Constable, Daniel D'Aquila, Phillip Smith, Sri R. Madabhushi, Andy Whiting, Tom Costelloe, Michael Collins
Summary: The study examines the environmental impacts of single use technologies (SUT) in biologics manufacturing and finds that the electricity usage is the largest contributor to the life cycle environmental impact. Surprisingly, the use of plastic SUT has a minimal impact on the end-of-life environmental footprint. The study suggests that improving process efficiency and reducing plant time are effective strategies for reducing the life cycle environmental impact of biologics manufacturing.
Article
Social Issues
Karla G. Cedano, Araceli Hernandez-Granados
Summary: Science Based Innovation relies on effective Technology Transfer efforts to define strategies that increase high-technology projects success in the market, facing market uncertainty and limited resources. Technology Intelligence plays a key role in reducing risks and improving decision making in this context.
TECHNOLOGY IN SOCIETY
(2021)
Editorial Material
Multidisciplinary Sciences
Claudi L. Bockting, Eva A. M. van Dis, Robert van Rooij, Willem Zuidema, Johan Bollen
Summary: To prevent potential harm to science and public trust, it is necessary to establish an independent scientific body to test and certify generative artificial intelligence.
Article
Engineering, Biomedical
Umberto M. Musazzi, Silvia Franze, Fabrizio Condorelli, Paola Minghetti, Paolo Caliceti
Summary: New and innovative nanomedicines have revolutionized the prognosis of many human diseases. However, their peculiar physicochemical properties pose new challenges in regulatory approval. This article critically discusses the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems, considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also proposed.
ADVANCED HEALTHCARE MATERIALS
(2023)
Article
Environmental Sciences
James C. Arnott, Maria Carmen Lemos
Summary: Scientific research aims to produce knowledge for sustainability decision-making and action, but defining and evaluating knowledge utilization and societal impact remains unclear. In-depth interviews with research project team leaders in the United States revealed challenges in defining 'use' and specific applications, reflecting the inherent complexities of knowledge production and utilization.
ENVIRONMENTAL SCIENCE & POLICY
(2021)
Article
Biochemistry & Molecular Biology
I-Heng Chiu, Tsen-Fang Tsai
Summary: Ixekizumab (Taltz(®)) is a humanized anti-IL-17A monoclonal antibody used to treat inflammatory diseases. Overweight or obesity may be protective against ixekizumab-induced injection site reactions, while a positive family history of psoriasis may be a potential risk factor. Additionally, patients experiencing diarrhea after ixekizumab injection are at higher risk for developing injection site reactions.
Review
Medicine, Research & Experimental
Anusha V. Matadh, Anusha Echanur, Sarasija Suresh, Laxmishanthi Chede, Howard Maibach, Vijay Kulkarni, S. Narasimha Murthy, H. N. Shivakumar
Summary: Pharmaceutical manufacturers have traditionally relied on batch manufacturing, which is a time-consuming and laborious process. However, recent advances in manufacturing technologies have led to the consideration of continuous manufacturing as a feasible alternative. Global regulatory agencies are promoting the adoption of continuous manufacturing to ensure product quality and reduce failures and recalls. However, there are technical and regulatory challenges in implementing innovative continuous manufacturing technologies.
MOLECULAR PHARMACEUTICS
(2023)
Article
Pharmacology & Pharmacy
Roberto Menzel, Ina Pahl, Samuel Dorey, Tanja Maier, Armin Hauk
Summary: Single-use devices in biopharmaceutical industry require comprehensive qualifications, including assessment of compounds released from these devices and their impacts on process performance, drug product quality, and patient safety. This study presents a comprehensive extractables study for three single-use components, comparing X-ray and gamma-ray irradiation methods. The results demonstrate the equivalency of both irradiation methods for extractables from plastic components used in pharmaceutical and biopharmaceutical manufacturing.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Pharmacology & Pharmacy
Michele Panzitta, Niccolo Calamassi, Cristina Sabatini, Marzia Grassi, Chiara Spagnoli, Vittoria Vizzini, Elisa Ricchiuto, Andrea Venturini, Andrea Brogi, Judit Brassier Font, Lino Pontello, Giorgio Bruno, Paola Minghetti, Maurizio Ricci
Summary: The European Pharmacopoeia includes chapters on Raman, NIR, and Chemometrics, and there is significant academia research on these topics. However, the implementation of spectroscopic techniques in the pharmaceutical industry is still slow. Successful applications of spectroscopy in pharmaceutical production departments highlight the need for industry-academia cooperation to expedite process innovation for the benefit of patients.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Environmental Sciences
Zijian Li, Shan Niu
Summary: This study proposed a simple screening approach to evaluate region-specific population health risks of soil pesticides by introducing region-specific factors. Simulations showed that pesticides thermodynamically stable in soil organics have large characterization factors, especially in colder regions. The study suggested that soil standards for malathion should be less strict in colder regions due to limited outdoor activities of children.
ECOTOXICOLOGY AND ENVIRONMENTAL SAFETY
(2021)
Article
Gastroenterology & Hepatology
Amar Vedamurthy, Nikitha Gangasani, Ashwin N. Ananthakrishnan
Summary: This retrospective study compared the risk of new or recurrent cancers in IBD patients with prior malignancy who were treated with Vedolizumab (VDZ), TNF-antagonists, or no immunosuppressive therapy. The results showed that neither VDZ nor TNF-antagonists were associated with an increased risk of new or recurrent cancers in these patients.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
(2022)
Article
Mathematics
Shih-Hsien Tseng, Hsiu-Chuan Chen, Tien Son Nguyen
Summary: This study explores the key success factors for sustainable development in traditional industries based on expert knowledge and proposes effective solutions. The results show that managers should focus on knowledge management and teamwork to enhance organizational sustainability.
Editorial Material
Computer Science, Interdisciplinary Applications
Daryl Powell, Maria Chiara Magnanini
Summary: This special issue introduces the contemporary advances in zero defect manufacturing. It has gained greater traction in recent years due to the widespread interest in and adoption of Industry 4.0. Zero defect manufacturing has the potential to disrupt and reshape the entire manufacturing ideology. The editorial provides an overview of the main findings from the selected papers in this special issue and presents reflections for the future of zero defect manufacturing research.
COMPUTERS IN INDUSTRY
(2023)
Article
Management
Luna Leoni, Marco Ardolino, Jamal El Baz, Ginetta Gueli, Andrea Bacchetti
Summary: This paper presents and empirically tests a conceptual model that examines the reciprocal relationships and impact of artificial intelligence (AI), knowledge management processes (KMPs), and supply chain resilience (SCR) on manufacturing firm performance (MFP). The study findings highlight the positive effects of AI adoption on KMPs, and the influence of KMPs on SCR and MFP.
INTERNATIONAL JOURNAL OF OPERATIONS & PRODUCTION MANAGEMENT
(2022)
Article
Computer Science, Cybernetics
Roulin Chen, Ling Cao
Summary: Drawing on the Resource-Capability-Competitive advantage framework, this study investigates how manufacturing companies can achieve green competitive advantage by focusing on internal motivation and identity perspectives. The findings indicate that green innovation behaviors mediate the relationship between organizational environmental identity and green competitive advantage. Additionally, slack resource moderates the interaction effect and mediation role in the main effect.
Article
Biotechnology & Applied Microbiology
Norichika Ogata, Akio Nishimura, Tomoko Matsuda, Michi Kubota, Takeshi Omasa
Summary: Cell-to-cell variability arises from a combination of intrinsic factors and extrinsic factors. Heterogeneity in high cell density suspension cultures for therapeutic protein production remains unknown. This study illustrates increasing heterogeneity in cellular transcriptome during high cell density suspension culture, without concomitant changes in genomic sequence.
BIOTECHNOLOGY AND BIOENGINEERING
(2021)
Article
Biotechnology & Applied Microbiology
Masahide Kido, Hideaki Idogaki, Kouji Nishikawa, Takeshi Omasa
Summary: This study evaluated the potency of violacein for cell cycle control and improvement of IgG production in CHO cells. Results showed that violacein increased IgG production by inducing G2/M phase arrest and without affecting product quality. This suggests that violacein has potential as a mAb production enhancer in CHO cells.
Article
Oncology
Motoki Hojo, Yukio Yamamoto, Yoshimitsu Sakamoto, Ai Maeno, Aya Ohnuki, Jin Suzuki, Akiko Inomata, Takako Moriyasu, Yuhji Taquahashi, Jun Kanno, Akihiko Hirose, Dai Nakae
Summary: A rat model of mesothelioma development caused by peritoneal injection of multiwalled carbon nanotubes was established, with detailed histological analysis revealing early mesothelioma characteristics and the potential involvement of altered apolipoprotein profiles in underlying mechanisms.
Article
Biotechnology & Applied Microbiology
Hajime Enatsu, Nako Okamoto, Yoshiki Nomura, Masayoshi Onitsuka, Noriko Yamano-Adachi, Yuichi Koga, Takeshi Omasa
Summary: Cartilaginous fishes like sharks have adaptive immune systems based on immunoglobulins, known as Immunoglobulin new antigen receptors (IgNARs). A recombinant expression system for IgNAR was successfully constructed in CHO cells, leading to successful expression and purification of IgNAR with antigen-binding ability.
JOURNAL OF BIOSCIENCE AND BIOENGINEERING
(2021)
Article
Cell Biology
Andrew Samy, Noriko Yamano-Adachi, Yuichi Koga, Takeshi Omasa
Summary: GRP94 is a chaperone protein involved in folding of unfolded proteins in the endoplasmic reticulum, and the truncated form without the KDEL motif can be naturally secreted into the medium in response to ER stress. This secretion phenomenon may shed light on the functional role of GRP94 as a trafficking molecule during the unfolded protein response.
Article
Multidisciplinary Sciences
Eiko Shimizu, Hiroki Iguchi, Minh Nguyen Tuyet Le, Yuta Nakamura, Daigo Kobayashi, Yuhei Arai, Kenta Takakura, Seiko Benno, Noriko Yoshida, Masayoshi Tsukahara, Satoshi Haneda, Kouichi Hasegawa
Summary: In this study, a chemically synthetic culture substrate was developed for the expansion and differentiation of human pluripotent stem cells. The substrate exhibited thermotolerance and underwater stability, and could be stored at room temperature. It supported hPSC expansion with similar efficiency to commercial substrates and enabled directed differentiation.
SCIENTIFIC REPORTS
(2022)
Article
Medicine, Research & Experimental
Yuko Kitano, Sayaka Nishimura, Tomoaki M. Kato, Anna Ueda, Kaho Takigawa, Masafumi Umekage, Masaki Nomura, Ayane Kawakami, Haruna Ogawa, Huaigeng Xu, Akitsu Hotta, Naoko Takasu, Masayoshi Tsukahara
Summary: In this study, we optimized the protocol for GMP-compatible CRISPRCas9 genome editing to simultaneously deplete three gene loci in HLA homozygous iPSCs. The successful depletion of HLAs was confirmed by RNA-seq and flow cytometry analyses, and the differentiation into cardiomyocytes was verified. However, unexpected genomic changes were observed in some clones, highlighting the importance of multidimensional analyses to ensure the safety and quality of genome-edited cells.
MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT
(2022)
Article
Biotechnology & Applied Microbiology
Yutaka Kirimoto, Noriko Yamano-Adachi, Yuichi Koga, Takeshi Omasa
Summary: Therapeutic antibodies are highly effective biopharmaceuticals with fewer side effects and longer half-life in the blood. This study focused on the intracellular trafficking of antibody-producing CHO cells and identified the accumulation of antibodies in the endoplasmic reticulum (ER) due to insufficient cargo receptors. Overexpression of the cargo receptor complex, ERGIC-53-MCFD2, improved antibody production but also increased intracellular antibody retention.
JOURNAL OF BIOSCIENCE AND BIOENGINEERING
(2023)
Article
Cell & Tissue Engineering
Yoshiki Nakashima, Masayoshi Tsukahara
Summary: This article discusses the impact of laminin-511 on the alpha 6 beta 1 integrin-Fyn-RhoA-ROCK signaling pathway in human induced pluripotent stem cells (hiPSCs) and explores this impact through validation experiments. Laminin-511 activation enhances cell survival and protects against apoptosis through the interaction with E-cadherin and the activation of PI3K signaling and cytoskeletal actin.
STEM CELLS AND DEVELOPMENT
(2022)
Article
Multidisciplinary Sciences
Yoshiki Nakashima, Chika Miyagi-Shiohira, Issei Saitoh, Masami Watanabe, Masayuki Matsushita, Masayoshi Tsukahara, Hirofumi Noguchi
Summary: Human hepatocytes were transformed into induced pluripotent stem cells (iPSCs) using Sendai virus vectors. The iPSCs expressed hepatocyte-specific markers and showed better efficiency in differentiating into hepatocyte-like cells compared to other types of iPSCs.
Article
Biotechnology & Applied Microbiology
Noriko Yamano-Adachi, Yuto Nakanishi, Wataru Tanaka, YuanShan Lai, Masahiro Yamazaki, Laura Zenner, Hirofumi Hata, Takeshi Omasa
Summary: This study investigated the effects of artificial changes in the chromosome number on productivity in CHO cells. It was found that cell populations with a diverse chromosome number distribution exhibited higher antibody productivities. Additionally, inducing aneuploid cells using 3-aminobenzamide increased antibody productivity. Furthermore, using host cells with an average chromosome number of 37 significantly improved antibody productivity and increased the integration of exogenous genes into the genome.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Biotechnology & Applied Microbiology
Zhou Xing, Thao Bich Nguyen, Guirong Kanai-Bai, Noriko Yamano-Adachi, Takeshi Omasa
Summary: A novel kinetic model was developed to simulate the production process of a CVA6 VLP vaccine, and the optimal operating conditions that balanced product yield and quality were predicted through multiple objective optimization.
Article
Medicine, Research & Experimental
Shinsuke Yoshida, Tomoaki M. Kato, Yoshiko Sato, Masafumi Umekage, Tomoko Ichisaka, Masayoshi Tsukahara, Naoko Takasu, Shinya Yamanaka
Summary: A clinically applicable iPSC haplobank has been established in Japan, consisting of 27 iPSC lines that match approximately 40% of the Japanese population. These lines have been used in over 10 clinical trials since their release in 2015.
Article
Materials Science, Biomaterials
Yoshiki Nakashima, Shinsuke Yoshida, Masayoshi Tsukahara
Summary: Previous belief regarding the compatibility of human induced pluripotent stem cells (hiPSCs) and the coating material Laminin 221 has been challenged by this study. It was found that hiPSCs derived from human mononuclear cells can form peninsular-like colonies when cultured on Laminin 221, and these colonies can be passaged multiple times. The expression of undifferentiated markers tends to be higher in hiPSCs cultured on Laminin 221, and these cells also showed the ability to differentiate into cardiomyocytes on Laminin 221.
REGENERATIVE BIOMATERIALS
(2022)
Article
Cell & Tissue Engineering
Yoshiki Nakashima, Hiroki Iguchi, Kenta Takakura, Yuta Nakamura, Kenji Izumi, Naoya Koba, Satoshi Haneda, Masayoshi Tsukahara
Summary: The constituent motifs of fibronectin are useful for adhesion of islets and duct epithelial cells. Adhesion and function of islets are enhanced by the presence of fibronectin motifs, while adhesion of duct epithelial cells is also promoted.
CELL TRANSPLANTATION
(2022)