A collaborative study to establish the second national standard for antithrombin concentrate in Korea.

This study aimed to establish a second national standard for antithrombin (AT) concentrate that can be used for potency assays of AT products. A collaborative study was conducted involving four laboratories, including national control laboratories and manufacturers in Korea, and the suitability of a candidate material to serve as the second national standard for AT concentrate was evaluated. The candidate material was manufactured using a process approved for Good Manufacturing Practices.

Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea.

Plasma-derived medicinal products (PDMPs) are essential in the treatment of acute and chronic life-threatening diseases. The Korea Ministry of Food and Drug Safety has conducted a national lot release (NLR) of PDMPs since 2012 based on a summary protocol review system and lot release testing. However, few studies have investigated the performance or characteristics of the NLR framework.

Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation.

The Eighth Asian National Control Laboratory (NCL) Network meeting, entitled "Biological Products Quality Control and Self-Sufficiency Strategy focusing on plasma-derived medicinal products (PDMPs)" was held in Seoul on 31 August 2023. The participants were NCL experts from Indonesia, Japan, Malaysia, the Philippines, Vietnam, and the Republic of Korea. Special lectures included the PDMPs self-sufficiency strategies of the World Health Organization (WHO) and Indonesian Food and Drug Authority, and a case study on Global Benchmarking Tool (GBT) assessment for vaccines by the Korea Ministry of Food and Drug Safety.

Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states.

The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online.

Optimization of Electrical and Mechanical Properties through the Adjustment of Design Parameters in the Wet Spinning Process of Carbon Nanotube/Polyvinylidene Fluoride Fibers Using Response Surface Methodology.

The optimal process conditions for fabricating carbon nanotube (CNT)/polyvinylidene fluoride (PVDF) fibers with varying properties using a wet spinning process were experimentally determined. A dope solution was prepared using multi-walled nanotubes, PVDF, and dimethylacetamide, and appropriate materials were selected. Design parameters affecting the chemical and physical properties of CNT/PVDF fibers, such as bath concentration, bath temperature, drying temperature, and elongation, were determined using a response surface method.

A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea.

This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular size distribution, and potency.

A Wet-Spinning Process for Producing Carbon Nanotube/Polyvinylidene Fluoride Fibers Having Highly Consistent Electrical and Mechanical Properties.

Studies of polymer/carbon nanotube (CNT) fibers typically focus on optimizing the overall properties, and the effects of structural variation on these properties are ignored. Thus, we investigated the longitudinal variation in the properties of CNT/polyvinylidene fluoride (CNT/PVDF) fibers prepared by wet spinning a solution of multi-walled nanotubes, PVDF, and dimethylacetamide. To this end, materials for the CNT/PVDF fiber were selected, and a dope solution was prepared using MWNT, PVDF, and dimethylacetamide (DMAc).

Standardization of the first Korean national reference standard for snake () antivenom.

In 2017, the second national reference standard (NRS) for Gloydius snake venom was established to replace the first NRS for Gloydius snake venom. In connection with the second venom NRS, a candidate for the first NRS for Gloydius snake antivenom was produced in 2017. In this study, the qualification of the candidate was estimated and the potency was determined by a collaborative study.

Germinated soy germ extract ameliorates obesity through beige fat activation.

Obesity is a worldwide public health concern requiring safe and effective strategies. Recent studies suggest that bioactive compounds from soybeans have beneficial effects on weight loss and reducing fat accumulation. However, despite the biochemical and nutritional changes during germination, the biological effects of germinated soy germ have not been fully investigated.

Corrigendum to "Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards"[Osong Public Health Res Perspect 2018;9(5):278-82].

[This corrects the article on p. 278 in vol. 9, PMID: 30402384.

Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards.

Objectives: Vaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children.

Germinated soy germ with increased soyasaponin Ab improves BMP-2-induced bone formation and protects against in vivo bone loss in osteoporosis.

Osteoporosis is frequently induced following menopause, and bone fractures result in serious problems including skeletal deformity, pain, and increased mortality. Therefore, safe and effective therapeutic agents are needed for osteoporosis. This study aimed to clarify the bone protecting effects of germinated soy germ extracts (GSGE) and their mode of action.

Stability Evaluation of National Reference Standards for Blood Products in Korea.

National reference standards (NRSs) for biologics are established through potency estimation by a multicenter joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via / bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results.

Effect of Rubus coreanus extracts on diabetic osteoporosis by simultaneous regulation of osteoblasts and osteoclasts.

Objective: Diabetes mellitus has been known to be associated with a high risk of osteoporosis. Rubus coreanus Miquel, a traditional Asian herbal medicine, has various uses, such as antiobesity and antiosteoporosis treatment, among others. We investigated the effect of R.

Establishment of the korean tolerable daily intake of bisphenol a based on risk assessments by an expert committee.

Recently, reproductive and neurobehavioral effects of bisphenol A (BPA) have been documented, and thus a review was requested for BPA management direction by the government. Therefore, this study was performed to establish a Korean tolerable daily intake (TDI) for BPA. An expert committee, consisting of specialists in fields such as toxicology, medicine, pharmacology, and statistics, was asked to evaluate BPA health based guidance values (HbGVs) .