Good Manufacturing Practice (GMP) Translation of Advanced Cellular Therapeutics: Lessons for the Manufacture of Erythrocytes as Medicinal Products.
Sign Up to like & getrecommendations! Published in 2018 at "Methods in molecular biology"
DOI: 10.1007/978-1-4939-7428-3_18
Abstract: Blood transfusion is a mainstay of modern medical practice. In many parts of the world the use of this life-saving therapy is hampered by issues of supply and the potential for transfusion transmitted infections. Accordingly,… read more here.
Keywords: cellular therapeutics; manufacturing practice; practice gmp; practice ... See more keywords
Development of an optimized closed and semi-automatic protocol for Good Manufacturing Practice manufacturing of tumor-infiltrating lymphocytes in a hospital environment.
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DOI: 10.1016/j.jcyt.2020.07.011
Abstract: BACKGROUND AIMS Several studies report on Good Manufacturing Process (GMP)-compliant manufacturing protocols for the ex vivo expansion of tumor-infiltrating lymphocytes (TILs) for the treatment of patients with refractory melanoma and other solid malignancies. Further opportunities… read more here.
Keywords: infiltrating lymphocytes; protocol; tumor infiltrating; manufacturing ... See more keywords
Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan
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DOI: 10.3390/ijerph17134748
Abstract: Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To… read more here.
Keywords: dietary supplements; manufacturing practice; company; gmp ... See more keywords
A New Human Platelet Lysate for Mesenchymal Stem Cell Production Compliant with Good Manufacturing Practice Conditions Preserves the Chemical Characteristics and Biological Activity of Lyo-Secretome Isolated by Ultrafiltration
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DOI: 10.3390/ijms23084318
Abstract: Recently, we proposed a Good Manufacturing Practice (GMP)-compliant production process for freeze-dried mesenchymal stem cell (MSC)-secretome (lyo-secretome): after serum starvation, the cell supernatant was collected, and the secretome was concentrated by ultrafiltration and freeze-dried, obtaining… read more here.
Keywords: cell; hpl; production; activity ... See more keywords
Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings.
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DOI: 10.3897/folmed.62.e49802
Abstract: 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 standard… read more here.
Keywords: inspection; medicinal products; manufacturing practice; good manufacturing ... See more keywords