• 한국수산과학회지
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• 제53권2호
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• pp.237-243
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• 2020

Listeria sp. is one of the pathogenic bacteria causes the infection listeriosis, through mainly raw food such as fishery food, dairy food and vegetables. Listeria sp. is a Gram-positive, non-spore-forming, motile, and facultative anaerobic bacterium. Because of the tolerance of Listeria sp. to low temperature and high salt concentration, it is very difficult to prevent them contaminated in the food, which do not require heating, especially, such as raw fishery products. So prevention and removal of bacterial contamination at the food manufacturing stage is the best method. In this study, therefore, several natural products including Psidium guajava and Geranium thunbergii were screened to investigate the antibacterial activity against Listeria sp., with expectation of fewer side effects and fewer resistance problems. Significant effects of two extracts were confirmed by well diffusion assay, MIC assay, and growth inhibition assay. P. guajava and G. thunbergii showed MIC values at 64-256 ㎍/mL meaning strong antibacterial activities against 6 kind of Listeria sp. tested. And the growth of Listeria sp. in the liquid media was actually inhibited by the addition of these two extracts.

• 디지털융복합연구
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• 제20권1호
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• pp.47-54
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• 2022

본 연구의 목적은 바이오의약품산업 육성을 위한 정책의 우선순위를 도출하기 위하여 수행되었다. 이를 위해 본 연구에서는 경기도 바이오의약품산업 육성 정책의 시급성과 중요도에 대해 조사하고, IPA 분석을 통해 바이오의약품산업 정책의 우선순위를 분석하였다. 연구결과, 바이오의약품산업 육성 정책의 최우선지원과제는 '연구개발 지원', '전문인력 양성', '사업화 지원'으로 나타났다. 바이오의약품분야별 정책우선순위 도출 결과 '연구개발 지원'과 '전문인력 양성'은 공통적으로 높게 나타났으며, 세포치료제, 첨단바이오융복합제제 등 산업분야별 정책 우선순위의 차이를 확인하였다. 또한, 정책수요는 R&D 자금지원, 임상시험 지원, 사업화 자금지원 등이 높게 나타났다. 본 결과를 바탕으로 정부의 바이오의약품산업 육성 정책은 '연구개발 지원'과 '전문인력 양성' 중심으로 지원하고 각 산업분야별 특성을 고려한 맞춤형 지원이 필요하다는 정책적 시사점을 도출하였다.

• 한국수산과학회지
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• 제56권5호
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• pp.721-727
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• 2023

This study was conducted to evaluate the level of microbial contamination in smoked salmon products sold in hypermarkets in major metropolitan cities in Korea. Listeria monocytogenes is the primary cause of smoked and raw salmon product recalls. Here, we used L. monocytogenes as a bacterial hygiene indicator and investigated the microbial contamination level of frozen/refrigerated smoked salmon products collected from hyper markets. Contamination levels were analyzed by seasons, manufacturers, and consumption regions. For hygiene indicator bacteria, total bacteria count, coliforms, and Escherichia coli were examined according to the food code established by the Ministry of Food and Drug Safety, and polymerase chain reaction (PCR) was performed to detect Listeria sp. The highest contamination level was observed in spring in Busan among five consumption regions. Listeria was detected at a level of 2.1% among all samples collected. And especially L. monocytogenes was detected in two cases from the samples collected from Daegu and Daejeon. Sanitary standards and specifications should be established according to the contamination level of smoked salmon products investigated in this study, and continuous monitoring is necessary.

• Asian Journal of Innovation and Policy
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• 제8권2호
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• pp.180-207
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• 2019

This article explores the historical evolutionary process of the biopharmaceutical industry of Korea, and how intentional and unintentional policy interventions have triggered the creation of the industry's system dynamics and paved the way for the generation of a few global leading products, including biosimilar, as well as next-generation therapeutics of gene and cell. The policies cover the simple technology transfer of API synthesis to overcome the endemic parasitic disease, new substance patent adoption and new drug development consortia, human resource development, various national initiatives influenced by the Human Genome Project, and venture promotion schemes. The scope and implementation tools under these policies have been aligned and refined to transform traditional fine chemical-based pharmaceuticals, to stimulate large companies' participation and to create technology-based venture companies in the biopharma business of Korea.

• 한국응용과학기술학회지
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• 제23권4호
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• pp.340-346
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• 2006

The influences of fluorescence, scattering, and flocculation in turbid material by light scattering were interpreted for the scattered fluorescence intensity and wavelength, it has been studied the molecular properties by the spectroscopy of laser induced fluorescence (LIF). The effects of optical properties in scattering media have been found by the optical $parameters({\mu}_s,\;{\mu}_a,\;{\mu}_t)$. Flocculation is an important step in many solid-liquid separation processes and is widely used. When two particles approach each other, interactions of several colloid particles can come into play which may have major effect on the flocculation and LIF process, The value of scattering coefficient ${\mu}_s$ is large by means of the increasing particles of scatterer it has been found that the slope decays exponentially as a function of distance from laser source to detector. It may also aid in designing the best model for oil chemistry, biopharmaceutical products, laser medicine and application of medical engineering on LIF and coagulation in particle transport mode.

• Journal of mucopolysaccharidosis and rare diseases
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• 제1권1호
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• pp.23-27
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• 2015

Recent research trends of human growth hormone (hGH) are divided into improved first-generation products, long-acting second-generation products, and biosimilar products. Among the improved first-generation products studies, studies of injection devices are being actively conducted. The long-acting second-generation products are focused on extending the half-life of hGH, and depending on the results of the clinical trials, the candidates are expected to lead the future hGH market. Finally, biosimilar has had less impact on the hGH market before now; however, expectations of low-cost products still remainas an opportunity.

• 멤브레인
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• 제30권1호
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• pp.9-20
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• 2020

바이오 의약품 생산과정의 대부분 공정에서 분리막이 사용되고 있다. 분리막 공정은 다른 공정의 전처리, 공정 자체의 불순물 분리, 바이러스 제거, 목표 생성물 농도 조절 및 완충 용액 교환 등에 사용된다. 인체에 사용하는 바이오 의약품의 바이러스 오염은 심각한 임상 결과와 직결되는 민감한 문제이기 때문에 바이러스 필터는 제품의 효능과 안정성을 보장하기 위해 중요한 역할을 한다. 바이러스 필터는 일반적으로 표면 개질된 PVDF, PES, CRC 등 다양한 고분자로 만들어진 복합다층 구조를 가지고 있다. 제조업체에 따라 대칭(symmetric) 또는 비대칭(asymmetric) 등 다른 기공 구조와 형태를 가지고 있으며, 주름막, 평판 시트 또는 중공사 형태로 사용된다. 바이러스 필터는 Asahi Kasei 를 비롯해 Millipore, Pall, Sartorius 등 몇몇 해외 업체들이 독점적으로 국내에 공급하고 있다. 바이러스 필터를 대체하려면 검증작업을 통해 규제기관의 승인을 받는 등 상당한 시간과 비용이 소요된다. 최근 일본의 수출규제로 국산화가 중요해진 만큼 제거 성능 고도화 등 선제적으로 기술자립도를 높여가야 한다.

• 한국빅데이터학회지
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• 제9권1호
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• pp.141-152
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• 2024

바이오의약품 위탁생산 사업(CMO)에서 다양한 고객의 주문에 대해 납기를 만족시키는 생산 일정계획을 수립하는 것은 사업이 경쟁력 측면에서 매우 중요하다. CMO 공정에서 각 주문은 다수의 배치로 구성되어 있으며 복수 개의 생산라인에 소량의 배치 단위로 할당되어 병렬 생산할 수 있다. 본 연구는 동종 병렬설비를 보유하고 있는 CMO 공정에서 주문의 총 납기 지연을 최소화하는 일정계획을 수립하기 위한 메타휴리스틱 알고리즘을 제안한다. 제안된 알고리즘은 생물학적 진화에서 영감을 받아 염색체와 같은 데이터 구조를 무작위로 생성하여 특정 문제를 해결하며, 교차 및 돌연변이와 같은 작업을 사용하여 다양한 솔루션을 효과적으로 탐색한다. 국내 CMO 기업체에서 제공한 현업 데이터를 기반으로 컴퓨터 실험을 진행하여 제안한 알고리즘이 기업체에서 사용하고 있는 전문가 알고리즘과 상용 최적화 패키지보다 우수한 일정계획을 적절한 계산시간 내에 도출하는 것을 확인하였다.

• 응용통계연구
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• 제25권1호
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• pp.125-138
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• 2012

최근 들어 바이오시밀러에 대한 국내외 관심이 매우 증가하고 있다. 바이오시밀러가 오리지널 생물의약품과 효능과 안전성이 유사함을 보이기 위해서는 최종적으로 임상시험을 수행하여야 한다. 본 논문에서는 이러한 임상시험의 수행과 통계적 분석에 필요한 여러 방법들과 외국의 사례 그리고 관련된 가이드라인들을 살펴볼 것이다.

• Journal of Pharmaceutical Investigation
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• 제39권4호
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• pp.263-267
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• 2009

The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.