Evaluating health information provided to kratom consumers by good manufacturing practice-qualified vendors [PDF]
Background “Kratom” commonly refers to the botanical Mitragyna speciosa, native to Southeast Asia, which is increasingly used globally for its unique pharmacological effects.
Katherine Hill +5 more
doaj +2 more sources
Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan. [PDF]
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.
Sato K, Kodama K, Sengoku S.
europepmc +2 more sources
Analytical Comparison of Antibody-drug Conjugates Based on Good Manufacturing Practice Strategies
The production of antibody-drug conjugates (ADCs) has been in great demand in the field of cancer therapeutics. Although cysteine-based conjugation is the most common and well known process for producing ADCs, multiple analytical methods are required for
Brian A Mendelsohn, Yutaka Matsuda
exaly +2 more sources
Peptide therapeutics represents a significant and growing area for manufacturing companies utilizing both chemical and recombinant methods. Approvals for orally administered peptides such as Linzess® (linaclotide), Trulance® (plecanatide), and most ...
Michael W. Pennington +2 more
doaj +2 more sources
Citation: 'good manufacturing practice' in the IUPAC Compendium of Chemical Terminology, 5th ed.; International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. 10.1351/goldbook.08075 • License: The IUPAC Gold Book is licensed under Creative Commons Attribution-ShareAlike CC BY-SA 4.0 International for individual terms.
Phil Ambery +2 more
exaly +6 more sources
A Full Good Manufacturing Practice–Compliant Protocol for Corneal Stromal Stem Cell Cultivation [PDF]
Corneal scarring, a significant cause of global blindness, results from various insults, including trauma, infections, and genetic disorders. The conventional treatment to replace scarred corneal tissues includes partial or full-thickness corneal ...
Mithun Santra +8 more
doaj +2 more sources
Development of genetic quality tests for good manufacturing practice-compliant induced pluripotent stem cells and their derivatives. [PDF]
Although human induced pluripotent stem cell (hiPSC) lines are karyotypically normal, they retain the potential for mutation in the genome. Accordingly, intensive and relevant quality controls for clinical-grade hiPSCs remain imperative.
Jo HY +13 more
europepmc +2 more sources
Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards [PDF]
Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for ...
Ji-Eun Han +6 more
doaj +2 more sources
Good Manufacturing Practice Strategy for Antibody-Drug Conjugate Synthesis Using Site-Specific Chemical Conjugation: First-Generation AJICAP. [PDF]
The development of antibody–drug conjugates (ADCs) is in great demand in the oncology field. With the goal of maximizing the therapeutic index, the conjugation technology to produce ADCs has been shifted to a site-specific manner; however, it is still ...
Matsuda Y +4 more
europepmc +2 more sources
Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice. [PDF]
Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications.
Gándara C, Affleck V, Stoll EA.
europepmc +2 more sources

