• Journal of Pharmaceutical Investigation
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• 제30권2호
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• pp.139-143
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• 2000

Gene therapy is becoming a very promising and feasible medical intervention as the understanding of human diseases extends to their molecular levels. Since the first US Food and Drug Administration (FDA)-approved human gene therapy protocol was approved in 1990, over 300 human clinical trial protocols had been approved worldwide so far. Even though some of the domestic gene therapy clinical trials also proved promising and more are awaiting, it should be emphasized that many safety aspects as well as effectiveness aspects should be considered during the development process. Moreover, there seems to be less restricted guidelines from the National Control Authority (NCA) in initiating human clinical trials. This article is intended to suggest some basis and points to consider in the development and evaluation of gene therapy products including antisense oligonucleotides pharmaceuticals.

• Journal of Plant Biotechnology
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• 제29권1호
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• pp.59-62
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• 2002

Samyang Genex succeeded in commercialization of anticancer agent-paclitaxel by plant cell culture technology. The core technology of Samyang Genex relating paclitaxel production includes cell line development, cell line preservation, cell culture, scale-up technology, and purification technology. On the basis of the research, Samyang Genex built the factory operated by CGMP (current good manufacturing practice). The paclitaxel-Genexol$^{TM}$-is commercially available in Korea, and it will be launched to world market including USA after approval of US FDA.

• 대한의생명과학회지
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• 제25권3호
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• pp.201-210
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• 2019

The oncolytic viruses selectively infect and destroy cancer cells, not harming normal cells. The cancer cell materials released by oncolysis, like tumor antigens, stimulate host antitumor immune responses, which is a long-lasting antitumor immunity removing cancer cells in remote parts of the body by a systemic response. Oncolytic viruses armed with transgenes such as cytokines or other immune stimulating factors enhance the immune responses. The first oncolytic virus approved by US-FDA is $Imlygic^{(R)}$ targeting for melanoma. The oncolytic virus is considered as a revolutionary immunotherapy for tumors together with immune checkpoint inhibitors. A variety of oncolytic viruses are under research in the treatment of kidney cancer, liver cancer, breast cancer, and many others solid tumors. Clinical trials have shown promising results in different types of cancers. Here, we present a brief introduction of various aspects of oncolytic virus, and a review of the current status of oncolytic virus therapy development.

• 식품과학과 산업
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• 제53권3호
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• pp.264-276
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• 2020

Ionizing radiation is one of the efficient non-thermal pasteurization methods. The US Food and Drug Administration (FDA) allows the use of ionizing radiation to a dose up to 10 kGy for controlling foodborne pathogens and extending the self-life of foods. Recently X-rays, generated on absorption of high energy electrons in an appropriate metal target, have been used commercially for sterilization purposes. X-rays have the advantages of higher penetration power than E-beams and absence of harmful radioactive sources, such as Cobalt-60 or Cesium-137 associated with gamma-rays. That is why it has continued to receive attention as an attractive alternative to gamma-ray or E-beam irradiation. In this article, the potential of X-ray irradiation for controlling foodborne pathogens in various food products and necessary pre-requisite knowledge for the introduction of X-ray irradiation to the Korean food industry will be provided.

• Journal of Dental Anesthesia and Pain Medicine
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• 제23권5호
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• pp.287-291
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• 2023

Sugammadex has shown faster reversal of steroidal neuromuscular blockade (NMB) than neostigmine, a traditional reversal agent for NMB, even in the intense block phase. This efficiency is possible because of the unique mechanism of action by encapsulating the NMB molecules. Therefore, with the use of sugammadex, we can also expect to avoid direct interactions with the cholinergic system and its subsequent side effects, which are disadvantages of traditional drugs. However, despite these benefits and US Food and Drug Administration (FDA) approval in 2015, rare adverse events associated with sugammadex have been reported. Herein, we report a case of bronchospasm that developed immediately after sugammadex administration.

• 한국약용작물학회지
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• 제5권3호
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• pp.196-201
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• 1997

당귀 반수체 육성의 기초차료를 얻고자 배양 소포자의 활력과 특성을 Flow cytometry로 관찰한 바 그 결과를 요약하면 다음과 같다. 1. 소포자 활력은 발육 시기에 따라 차이를 보여 배양 4일경에 4분자기 12.8%, 1핵성소포자기 49.3%, 2핵성소포자기 42.3% 및 성숙화분은 56.4%였다. 그리고 배양 20일 경에 는 소포자의 활력이 감소하여 배양중 배지개선과 계대배양이 요구됨을 알 수 있었다. 2. 발육시기에 따라 소포자 구조 peak가 다르게 조사되어 4 분자기는 원형을 보이다가 $1{\sim}2$핵성 소포자 부터 성속 화 분은 장타원형의 발달하는 특성을 띠었다. 3. 배양 소포자 중 살아서 생존한 소포자는 FDA 염색에 녹색 형광을 DAPI 염색에 청색형광을 발하여 활력이 있음을 알 수 있었다.

• 한국수산과학회지
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• 제48권5호
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• pp.604-613
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• 2015

The objective of this study was to estimate the food quality of commercial boiled-dried Pacific herring Clupea pallasi as a substitute for boiled-dried anchovy. Standards for controlling quality of boiled-dried Pacific herring were suggested based on international (US FDA and CODEX) and domestic (Korean FDA, Standards on Quality of Seafood and Seafood Products, KS) standards for boiled-dried anchovy. The standards included requirements for moisture [less than 30% (less than 35 in very tiny sizes)], water activity (less than 0.85), salinity (less than 10%), water-phase salt (less than 20%), acid-insoluble ash (less than 1.5%), yeast and mold (fewer than 1.0×10³ CFU/g), and different size and breakage (less than 5%). Based on the standards suggested, commercial boiled-dried Pacific herring passed nine levels (all levels) in water activity, acid-insoluble ash, mold and yeast concentrations; seven levels (L-1, 2, 3, 4, M-1, 2, S) in water-phase salt, and three levels (L-1, 3, 4) in the ratio of different size and breakage categories. These results suggest that the quality of commercial boiled-dried Pacific herring is similar to that of commercial boiled-dried anchovy.

• Korean Chemical Engineering Research
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• 제48권4호
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• pp.483-489
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• 2010

본 연구에서는 화상분석(image analysis)에 기반한 소프트 센서를 설계하고, 이를 색상-질감 특성을 가진 제품의 외관품질 자동분류에 적용하였다. 색상과 질감(texture)을 동시에 가진 화상을 분석하기 위해 다중해상도 다변량 화상분석(Multiresolutional Multivariate Image Analysis, MR-MIA) 기법을 이용하였으며, 자동 분류를 위한 감독 학습법(supervised learning)으로는 Fisher의 판별분석(Fisher's discriminant analysis)을 사용하였다. 잠재변수법의 하나인 Fisher의 판별분석을 사용하였기 때문에, 제품의 외관을 서로 다른 불연속적인 부류로의 분류할 수 있을 뿐 아니라, 연속적인 외관 변화를 일관적이고 정량적으로 추정함은 물론, 외관의 특성 해석 또한 가능하였다. 이 방법은 인조대리석 제조 공정에서 중간 및 최종 제품의 외관 품질을 자동으로 분류하는 데에 성공적으로 적용되었다.

• Journal of Microbiology and Biotechnology
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• 제21권9호
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• pp.954-959
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• 2011

There have been a number of studies conducted in order to compare the efficiencies of recovery rates, utilizing different protocols, for the isolation of L. monocytogenes. However, the severity of multiple cell injury has not been included in these studies. In the current study, L. monocytogenes ATCC 19112 was injured by exposure to extreme temperatures ($60^{\circ}C$ and $-20^{\circ}C$) for a one-step injury, and for a two-step injury the cells were transferred directly from a heat treatment to frozen state to induce a severe cell injury (up to 100% injury). The injured cells were then subjected to the US Food and Drug Administration (FDA), the ISO-11290, and the modified United States Department of Agriculture (mUSDA) protocols, and plated on TSAyeast (0.6% yeast), PALCAM agar, and CHROMAgar Listeria for 24 h or 48 h. The evaluation of the total recovery of injured cells was also calculated based on the costs involved in the preparation of media for each protocol. Results indicate that the mUSDA method is best able to aid the recovery of heat-injured, freeze-injured, and heat-freeze-injured cells and was shown to be the most cost effective for heat-freeze-injured cells.

• 대한이식학회지
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• 제31권4호
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• pp.157-169
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• 2017

Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.