Results 11 to 20 of about 9,951,844 (299)

Automated Good Manufacturing Practice-Compatible CRISPR-Cas9 Editing of Hematopoietic Stem and Progenitor Cells for Clinical Treatment of β-Hemoglobinopathies. [PDF]

CRISPR J, 2023
Cellular therapies hold enormous potential for the cure of severe hematological and oncological disorders. The forefront of innovative gene therapy approaches including therapeutic gene editing and hematopoietic stem cell transplantation needs to be ...
Ureña-Bailén G, Block M, Grandi T, Aivazidou F, Quednau J, Krenz D, Daniel-Moreno A, Lamsfus-Calle A, Epting T, Handgretinger R, Wild S, Mezger M.   +11 more
europepmc   +2 more sources

A New Human Platelet Lysate for Mesenchymal Stem Cell Production Compliant with Good Manufacturing Practice Conditions. [PDF]

Int J Mol Sci, 2022
Mesenchymal stem cells (MSCs) are classified as advanced therapy medicinal products, a new category of GMP (good manufacturing practice)-compliant medicines for clinical use.
Mareschi K, Marini E, Niclot AGSB, Barone M, Pinnetta G, Adamini A, Spadea M, Labanca L, Lucania G, Ferrero I, Fagioli F.   +10 more
europepmc   +2 more sources

Ethical argument for establishing good manufacturing practice for phage therapy in the UK. [PDF]

J Med Ethics
Antimicrobial resistance (AMR) poses an increasing threat to patient care and population health and there is a growing need for novel therapies to tackle AMR.
Suleman M, Clark JR, Bull S, Jones JD.
europepmc   +2 more sources

A model for assessment of Halal Good Manufacturing Practice in meat industry

Production and Manufacturing Research: An Open Access Journal, 2022
This research aimed to build an assessment model on the Halal Good Manufacturing Practices (HGMP) in the meat industry. Data collection was used at four slaughterhouses in Indonesia. This study collected data through two closed questionnaires involving a
Fitra Lestari, Mawardi Mawardi, Melfa Yola, Yuslenita Muda, Abu Bakar Abdul Hamid   +4 more
doaj   +2 more sources

Good manufacturing practice production of human corneal limbus-derived stromal stem cells and in vitro quality screening for therapeutic inhibition of corneal scarring. [PDF]

Stem Cell Res Ther
Background Mesenchymal stem cells in the adult corneal stroma (named corneal stromal stem cells, CSSCs) inhibit corneal inflammation and scarring and restore corneal clarity in pre-clinical corneal injury models.
Santra M, Geary ML, Rubin E, Hsu MYS, Funderburgh ML, Chandran C, Du Y, Dhaliwal DK, Jhanji V, Yam GH.   +9 more
europepmc   +2 more sources

Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings [PDF]

Folia Medica, 2020
Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum ...
Assena H. Stoimenova, Bogdan J. Kirilov, Stanislav R. Gueorguiev, Elina S. Petkova-Gueorguieva, Sava G. Ognianov   +4 more
doaj   +4 more sources

An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan [PDF]

Cost Effectiveness and Resource Allocation, 2022
Background Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity.
Rohullah Roien, Rajeev Shrestha, Kashikant Yadav, Akihiko Ozaki, M. Bashir Ahmadi, Yudai Kaneda, Yasuhiro Kotera, Binaya Sapkota, Sunil Shrestha   +8 more
doaj   +2 more sources

Recent Advances in Good Manufacturing Practice-Grade Generation of Dendritic Cells. [PDF]

Transfus Med Hemother, 2020
Dendritic cells (DCs) are pivotal regulators of immune responses, specialized in antigen presentation and bridging the gap between the innate and adaptive immune system.
Cunningham S, Hackstein H.
europepmc   +2 more sources

Good Manufacturing Practice-Grade of Megakaryocytes Produced by a Novel Ex Vivo Culturing Platform. [PDF]

Clin Transl Sci, 2020
Ex vivo (EV)‐derived megakaryocytes (MKs) have shown great promise as a substitute for platelets in transfusion medicine to alleviate a severe shortage of donor‐platelets. Challenges remain that include poor efficiency, a limited scale of production, and
Guan X, Wang L, Wang H, Wang H, Dai W, Jiang Y.   +5 more
europepmc   +2 more sources

Ex vivo-expanded highly pure ABCB5⁺ mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process validation and first in-human data. [PDF]

Cytotherapy, 2021
Background aim: Mesenchymal stromal cells (MSCs) hold promise for the treatment of tissue damage and injury. However, MSCs comprise multiple subpopulations with diverse properties, which could explain inconsistent therapeutic outcomes seen among ...
Kerstan A, Niebergall-Roth E, Esterlechner J, Schröder HM, Gasser M, Waaga-Gasser AM, Goebeler M, Rak K, Schrüfer P, Endres S, Hagenbusch P, Kraft K, Dieter K, Ballikaya S, Stemler N, Sadeghi S, Tappenbeck N, Murphy GF, Orgill DP, Frank NY, Ganss C, Scharffetter-Kochanek K, Frank MH, Kluth MA.   +23 more
europepmc   +2 more sources