Applicability of Bacterial Endotoxin Test (Bet) for Some Radiopharmaceutical Sterile Kits by the Use of Tachypleus Amebocyte Lysate (Tal)

Putra, Amal Rezka; Lestari, Enny; Kurniasih, Dede; Karyadi, Karyadi; Sarmini, Endang; Aries, Arni

doi:10.24071/jpsc.001694

Cited by 2 publications

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“…Endotoxin testing or TAL assay using the gel coagulation method was performed as previously described [ 16 ]. A total of 500 µL of control standard endotoxin (CSE) solution (concentration 0.0156 to 1 EU/ml) was mixed with 500 µL of horseshoe crab blood sample in a 1.5-ml pyrogen-free Eppendorf tube.…”

Section: Methodsmentioning

confidence: 99%

“…Results showed that factor C of T. gigas consists of a signal peptide and two glycoprotein chains, heavy chain and light chain. The signal peptides are located at amino acid positions 1-25, which consist of N-region signal peptide (1-5), H-region signal peptide(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17), and C-region signal peptide(18)(19)(20)(21)(22)(23)(24)(25). On the other hand, heavy chain has cysteine-rich regions (Cys-rich region), four complement control proteins (CCP), EGF (epidermal growth factor)-like, LCCL, and C-type lectin (CLECT).…”

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confidence: 99%

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Characterization, protein modeling, and molecular docking of factor C from Indonesian horseshoe crab (Tachypleus gigas)

Mustopa

Izaki

Suharsono

et al. 2023

Journal of Genetic Engineering and Biotechnology

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Background Horseshoe crab (Tachypleus gigas) amebocytes are useful biomedical components for endotoxin detection, and their growing needs for biomedical purposes cause the horseshoe crab population to decline. Factor C synthesis via genetic engineering offers a solution to replace natural horseshoe crab’s factor C and prevent its excessive harvest from nature. In response to these concerns, this study aimed to characterize the amebocyte lysates and factor C protein modeling of T. gigas originated from Banyuasin South Sumatra Estuary. Methods and results Sampling of T. gigas was carried out in Banyuasin South Sumatra Estuary, Indonesia. The endotoxin test or TAL (Tachypleus amebocyte lysates) assay was performed using gel coagulation method. Protein characterization of protease enzyme was conducted by protease activity, SDS-PAGE, and zymogram analysis. The cDNA of mitochondrial COI gene was amplified for molecular identification followed by cDNA cloning of factor C. Protein modeling was investigated by molecular docking and molecular dynamic (MD) simulation. Endotoxin test results showed that TAL-35 had endotoxin sensitivity in a range of 0.0156–1 EU/ml, while TAL 36 had a sensitivity between 00,625 and 1 EU/ml. T. gigas amebocytes have protease activity in molecular mass sizes less than 60 kDa, with 367 U/ml for TAL 35 and 430 U/ml for TAL 36. The molecular identification revealed 98.68% identity similarity to T. gigas. The docking results suggested three ligands; i.e., diphosphoryl lipid A, core lipid A, and Kdo2 lipid A can be activators of the factor C protein by binding to the region of the receptor to form a ligand-receptor complex. Conclusions Endotoxins can be detected using horseshoe crab amebocytes. The presence of proteases is considered responsible for this ability, as evidenced by casein zymogram results. According to docking and MD analysis, we found that lipopolysaccharides (LPS) participate to the binding site of factor C.

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Section: Methodsmentioning

confidence: 99%

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confidence: 99%

Characterization, protein modeling, and molecular docking of factor C from Indonesian horseshoe crab (Tachypleus gigas)

Mustopa

Izaki

Suharsono

et al. 2023

Journal of Genetic Engineering and Biotechnology

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“…A rise in temperature of 0.6°C in each rabbit or a total temperature of 1.4°C in three rabbits is indicative of the presence of pyrogenic matter. The rabbit test method, which is decided by considering the rise in fever of rabbits, is no longer used [30].…”

Section: Rabbit Pyrogenicity Testmentioning

confidence: 99%

Radyofarmasöti̇kleri̇n Kali̇te Güvencesi̇ Ve Kali̇te Kontrolü: Genel Bi̇r Bakiş

Ekinci

Santos-Oliveira

İlem-Özdemir

2022

Ankara Ecz. Fak. Derg.

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Objective: Radiopharmacy is a special field of pharmacy that examines, develops, conducts quality controls, deals with distribution and application of pharmaceutical forms called radiopharmaceuticals that are used for diagnostic and therapeutic purposes, carrying pharmaceutical and radioactive properties together. Radiopharmaceuticals contain radionuclides. This is the most important difference that distinguishes radiopharmaceuticals from other conventional drugs. Since radiopharmaceuticals are administered to humans, they must be sterile, pyrogen-free, isotonic, isohydric, and subject to all quality control tests required for conventional drug. Also, additional quality control tests are required due to radionuclide they contain. In this review, quality control tests applied to radiopharmaceuticals, hospital radiopharmacy laboratory types and Good Radiopharmacy Practices (GRP) will be discussed. Result and Discussion: Radiopharmaceuticals should be prepared in accordance with standards specified in relevant sections of pharmacopoeias. For each series of radiopharmaceuticals, tests prescribed in the pharmacopoeias and records must be kept. Production and preparation of radiopharmaceuticals should be carried out in accordance with Good Manufacturing Practices for sterile preparations and GRP for radioactive products. However, radiopharmaceuticals that pass quality control tests can be administered to patients after dose measurements are made in dose calibrators. Thus, the patient's safety and benefit are maximized, while the risk is minimized. Some radiopharmaceuticals with a short half-life are used before quality control tests are completed. In this case, the effectiveness and continuation of the quality assurance system should be tested at appropriate intervals. According to procedures performed by hospital radiopharmacy laboratories, international standards are determined as Level IA/B, Level IIA/B and Level IIIA/B/C. Quality assurance of radiopharmaceuticals is provided by a sufficient number of trained personnel within the scope of GRP, devices that have been calibrated and controlled, appropriate substances and a working order in which tests determined at each stage are made and results are recorded accurately and regularly.

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Applicability of Bacterial Endotoxin Test (Bet) for Some Radiopharmaceutical Sterile Kits by the Use of Tachypleus Amebocyte Lysate (Tal)

Cited by 2 publications

References 0 publications

Characterization, protein modeling, and molecular docking of factor C from Indonesian horseshoe crab (Tachypleus gigas)

Characterization, protein modeling, and molecular docking of factor C from Indonesian horseshoe crab (Tachypleus gigas)

Radyofarmasöti̇kleri̇n Kali̇te Güvencesi̇ Ve Kali̇te Kontrolü: Genel Bi̇r Bakiş

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