• The Journal of KAIRB
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• v.6 no.1
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• Journal of Digital Convergence
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• v.20 no.1
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• pp.47-54
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• 2022

The purpose of this study was to derive policy priorities for fostering the biopharmaceutical industry. In this study, the urgency and importance of the policy to foster the biopharmaceutical industry in Gyeonggi-do was investigated, and the priorities of the policy in the biopharmaceutical industry were analyzed through IPA analysis. As a result of the study, the top priority support tasks for the biopharmaceutical industry promotion policy were 'R&D support', 'Expert training', and 'commercialization support'. As a result of deriving policy priorities for each biopharmaceutical sector, 'R&D support' and 'Expert training' were found to be high in common, and differences in policy priorities for each industry such as cell therapy products and advanced bio-convergence products were confirmed. Also, as for the policy demand, R&D funding support, clinical trial support, and commercialization funding support were found to be high. Based on these results, the government's policy to foster the biopharmaceutical industry was supported with a focus on 'R&D support' and 'Expert training', and policy implications were drawn that customized support is needed in consideration of the characteristics of each industry field.

• Journal of Korea Port Economic Association
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• v.34 no.3
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• pp.1-16
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• 2018

The demand for biopharmaceuticals is on the rise spurred by the fourth industrial revolution and an aging society in Korea. Consequently, the scale of the biopharmaceutical industry is continuously increasing globally, thereby leading to an increase in the distribution of biopharmaceuticals. However, the relative inferiority of the domestic drug distribution structure, when compared to the advanced countries, and strict logistics regulations concerning the handling of biopharmaceuticals have raised the need for systematic management. Essentially, the significance of third-party logistics companies in the cold chain for pharmaceutical cold chain has increased with an intense management environment for pharmaceuticals. The purpose of this study is to investigate the selection factors of drug cold chain's third-party logistics companies and to examine the influence of selection factors on satisfaction. A multiple regression analysis was conducted to investigate how cold chain third-party logistics factors affect the satisfaction of third-party logistics in cold chain. The results of analysis showed that expertise, facility, and linkage are factors affect customer satisfaction. The managerial capacity was derived not as an influential factor. These findings suggest that the future cold chain industry will be equipped to provide direction and strategic implications.

• Biomolecules & Therapeutics
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• v.18 no.2
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• pp.184-190
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• 2010

Clinical cases of pure red cell aplasia (PRCA) have been reported during the recombinant human erythropoietin (EPO) therapy for the anemia patients. PRCA is a rare hematological disorder leading to a severe anemia due to an almost complete stop of red blood cell production. Antibody (Ab)-associated PRCA is caused by the EPO-neutralizing Abs that eliminate the biological activity of EPO. In order to detect anti-EPO Abs in human sera, we performed conventional ELISA, directly coated bridging ELISA, and streptavidin coated bridging ELISA, and compared their sensitivity and specificity. Some false positive results were obtained in the conventional ELISA. One positive sample was detected successfully by streptavidin coated bridging ELISA, which was not appeared in the directly coated bridging ELISA. In conclusion, streptavidin coated bridging ELISA was substantially sensitive and specific format and one out of sixty-eight serum samples was proved to be anti-EPO positive.

• Korean Journal of Microbiology
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• v.52 no.2
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• pp.140-147
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• 2016

A process for manufacturing virally-safe porcine bone hydroxyapatite (HA) has been developed to serve as advanced xenograft material for dental applications. Porcine bone pieces were defatted with successive treatments of 30% hydrogen peroxide and 80% ethyl alcohol. The defatted porcine bone pieces were heat-treated in an oxygen atmosphere box furnace at $1,300^{\circ}C$ to remove collagen and organic compounds. The bone pieces were ground with a grinder and then the bone powder was sterilized by gamma irradiation. Morphological characteristics such as SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy) images of the resulting porcine bone HA (THE Graft$^{(R)}$) were similar to those of a commercial bovine bone HA (Bio-Oss$^{(R)}$). In order to evaluate the efficacy of $1,300^{\circ}C$ heat treatment and gamma irradiation at a dose of 25 kGy for the inactivation of porcine viruses during the manufacture of porcine bone HA, a variety of experimental porcine viruses including transmissible gastroenteritis virus (TGEV), pseudorabies virus (PRV), porcine rotavirus (PRoV), and porcine parvovirus (PPV) were chosen. TGEV, PRV, PRoV, and PPV were completely inactivated to undetectable levels during the $1,300^{\circ}C$ heat treatment. The mean log reduction factors achieved were $${\geq_-}4.65$$ for TGEV, $${\geq_-}5.81$$ for PRV, $${\geq_-}6.28$$ for PRoV, and $${\geq_-}5.21$$ for PPV. Gamma irradiation was also very effective at inactivating the viruses. TGEV, PRV, PRoV, and PPV were completely inactivated to undetectable levels during the gamma irradiation. The mean log reduction factors achieved were $${\geq_-}4.65$$ for TGEV, $${\geq_-}5.87$$ for PRV, $${\geq_-}6.05$$ for PRoV, and $${\geq_-}4.89$$ for PPV. The cumulative log reduction factors achieved using the two different virus inactivation processes were $${\geq_-}9.30$$ for TGEV, $${\geq_-}11.68$$ for PRV, $${\geq_-}12.33$$ for PRoV, and $${\geq_-}10.10$$ for PPV. These results indicate that the manufacturing process for porcine bone HA from porcine-bone material has sufficient virus-reducing capacity to achieve a high margin of virus safety.