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Good manufacturing practice production of CD34+ progenitor-derived NK cells for adoptive immunotherapy in acute myeloid leukemia
Allogeneic natural killer (NK) cell-based immunotherapy is a promising, well-tolerated adjuvant therapeutic approach for acute myeloid leukemia...
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Evaluating health information provided to kratom consumers by good manufacturing practice-qualified vendors
Background“Kratom” commonly refers to the botanical Mitragyna speciosa , native to Southeast Asia, which is increasingly used globally for its unique...
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Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?
BackgroundAll currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The...
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An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
BackgroundAfghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide...
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Pharmaceutical good manufacturing practice: Leuplin® production in Japan identifies major international shortcomings
In Japan, the production of Leuplin ® , a key drug for the treatment of prostate cancer and breast cancer, was temporarily suspended in 2020 by the...
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Validation of the media fill method for Cytokine-Induced killer cells manufacturing process
BackgroundMedia fills are used to demonstrate the adequacy of the aseptic conditions of a pharmaceutical production process, according to good...
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Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing
Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working...
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Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals
This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the...
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Good practices for the automated production of 18F-SiFA radiopharmaceuticals
BackgroundThe positron emitting isotope fluorine-18 ( 18 F) possesses almost ideal physicochemical properties for the development of radiotracers for...
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Enabling the design of surgical instruments for under-resourced patients through metal additive manufacturing: ulnar shortening osteotomy as an example
BackgroundUlnar shortening osteotomy (USO) has demonstrated good outcomes for patients with ulnar impaction syndrome. To minimize complications such...
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Guiding principles on the education and practice of theranostics
PurposeThe recent development and approval of new diagnostic imaging and therapy approaches in the field of theranostics have revolutionised nuclear...
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Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
IntroductionPostmarketing drug safety surveillance research has focused on the product-patient interaction as the primary source of variability in...
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Additive manufacturing and three-dimensional printing in obstetrics and gynecology: a comprehensive review
Three-dimensional (3D) printing, also known as additive manufacturing, is a technology used to create complex 3D structures out of a digital model...
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Development of a workplace breastfeeding support practice model in South Africa
BackgroundGlobally, mothers have identified work as one of the main obstacles to exclusive and continued breastfeeding. The support a woman receives...
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Occupational safety practice among metal workers in Bangladesh: a community-level study
BackgroundThe overall information on occupational health and safety (OHS)-related knowledge and workplace practices are scarce in Bangladesh. This...
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Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India
Chimeric Antigen Receptor (CAR) T cell therapy is an accepted standard of care for relapsed/refractory B cell malignancies. However, the high cost of...
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Ex vivo manufacturing of platelets: beyond the first-in-human clinical trial using autologous iPSC-platelets
Platelet transfusion is a common clinical approach to providing platelets to patients suffering from thrombocytopenia or other ailments that require...
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Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study
ObjectiveAlteplase is a recombinant tissue plasminogen activator used for thrombolytic treatment in several indications and is currently approved in...
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A guide to the collection of T-cells by apheresis for ATMP manufacturing—recommendations of the GoCART coalition apheresis working group
Autologous chimeric antigen receptor-modified T-cells (CAR-T) provide meaningful benefit for otherwise refractory malignancies. As clinical...
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Practice Trends in (C)APD Assessment and Management: A Survey of Audiologists in Kerala
Aims Present study investigates the current trends in (Central) Auditory Processing Disorder [(C)APD] assessment and management practices among...
