Results 1 to 10 of about 9,951,844 (299)

Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents [PDF]

Biomaterials and Biosystems, 2021
Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also ...
Clara Sanz-Nogués, Timothy O'Brien
doaj   +5 more sources

The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence [PDF]

Frontiers in Medicine
IntroductionRegulatory agencies impose stringent legislation and guidelines in the pharmaceutical industry to ensure the safety and quality of medicinal products.
Aisha Al Azawei, Kate Loughrey, Kim Surim, Mary Elizabeth Connolly, Bernard D. Naughton, Bernard D. Naughton   +5 more
doaj   +5 more sources

Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production [PDF]

International Journal of Molecular Sciences, 2021
Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types.
Eva Rohde, Sandra Laner-Plamberger, Katharina Schallmoser   +2 more
exaly   +3 more sources

Exosomes in clinical trial and their production in compliance with good manufacturing practice [PDF]

Tzu Chi Medical Journal, 2020
Exosomes, 60-200-nm extracellular vesicles secreted from cells, have been used as an active pharmaceutical ingredient or drug carrier in disease treatment. Human- and plant-derived exosomes are registered in clinical trials, but more complete reports are
Yu-Shuan Chen, En-Yi Lin, Tzyy-Wen Chiou, Horng-Jyh Harn   +3 more
doaj   +3 more sources

Good Manufacturing Practice (GMP) Compliance for Phage Therapy Medicinal Products [PDF]

Frontiers in Microbiology, 2020
Facing the emergence of difficult-to-treat bacterial infections, the perspective of using bacteriophages has re-gained interest in many countries. In terms of pharmaceutical classification in EU and United States, phages are considered as anti-infectious
Laurent Bretaudeau, Karine Tremblais, Françoise Aubrit, Marc Meichenin, Isabelle Arnaud   +4 more
doaj   +3 more sources

Good manufacturing practice in low‐ and middle‐income countries: Challenges and solutions for compliance [PDF]

Public Health Challenges
Approximately 2 billion people globally have limited access to essential medicines, particularly those living in low‐ and middle‐income countries (LMICs).
Pelden Chejor, Thinley Dorji, Ngawang Dema, Andrew Stafford   +3 more
doaj   +3 more sources

Considering Cell Therapy Product “Good Manufacturing Practice” Status [PDF]

Frontiers in Medicine, 2018
The promise of cell therapies is beginning to be recognized internationally. Cell therapy products (CTPs) are different from other drug products because many aim to be curative, and they are less comprehensively characterizable and more variable ...
Patrick Bedford, Juliana Jy, Lucas Collins, Steven Keizer   +3 more
doaj   +3 more sources

Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly [PDF]

Cells, 2019
Background: The selection of assays suitable for testing the potency of clinical grade multipotent mesenchymal stromal cell (MSC)-based products and its interpretation is a challenge for both developers and regulators.
Joan Garcia-Lopez, Joaquim Vives, Marta Grau-Vorster   +2 more
exaly   +3 more sources

Mesenchymal Stem/Stromal Cell Production Compliant with Good Manufacturing Practice: Comparison between Bone Marrow, the Gold Standard Adult Source, and Wharton’s Jelly, an Extraembryonic Source [PDF]

Journal of Clinical Medicine, 2019
Many clinical trials report mesenchymal stem/stromal cells (MSCs) efficacy in various indications. Therefore, standardization of MSC production becomes necessary.
Daniele Bensoussan, Caroline Laroye, Loïc Reppel   +2 more
exaly   +3 more sources

Good manufacturing practice production of CD34⁺ progenitor-derived NK cells for adoptive immunotherapy in acute myeloid leukemia. [PDF]

Cancer Immunol Immunother, 2023
Allogeneic natural killer (NK) cell-based immunotherapy is a promising, well-tolerated adjuvant therapeutic approach for acute myeloid leukemia (AML). For reproducible NK cell immunotherapy, a homogenous, pure and scalable NK cell product is preferred ...
de Jonge PKJD, van Hauten PMM, Janssen LD, de Goede AL, Berrien-Elliott MM, van der Meer JMR, Mousset CM, Roeven MWH, Foster M, Blijlevens N, Hobo W, Fehniger TA, Jansen JH, Schaap NPM, Dolstra H.   +14 more
europepmc   +2 more sources