• 제목/요약/키워드: biopharmaceutical production

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The modulating activity of Ginsan on radiation-induced disturbance of antioxidant defense systems

  • Son, Soo-Jung;Kim, Chan-Wha;Yun, Yeon-Sook
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.309.1-309.1
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    • 2002
  • Ginsan, a polysaccharide extracted from Panax ginseng. was earlier scrutinized for a biological-response modifier. We further studied the protective and restorative activity of Ginsan against sublethal dose irradiation owing to increase production of endogenous hematopoietic growth factors such as IL-1. TNF-${\alpha}$. IL-6, GM-CSF. Which induce strong redox-emzyme elevation. Exposing to radiation induces reactive oxygen species (ROS). which play an important causative role in radiation damage. (omitted)

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바이오의약품 위탁생산 일정계획 수립을 위한 유전자 알고리즘 (A Genetic Algorithm for Production Scheduling of Biopharmaceutical Contract Manufacturing Products)

  • 김지훈;김정현;김재곤
    • 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.

바이오의약품 제조공정에서 분리막의 역할과 바이러스 필터 동향 (Membrane and Virus Filter Trends in the Processes of Biopharmaceutical Production)

  • 최태환;박호범
    • 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.

Single and Multi-Strain Probiotics Supplementation in Commercially Prominent Finfish Aquaculture: Review of the Current Knowledge

  • Sumon, Md Afsar Ahmed;Sumon, Tofael Ahmed;Hussain, Md. Ashraf;Lee, Su-Jeong;Jang, Won Je;Sharifuzzaman, S.M.;Brown, Christopher L.;Lee, Eun-Woo;Hasan, Md. Tawheed
    • Journal of Microbiology and Biotechnology
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    • 제32권6호
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    • pp.681-698
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    • 2022
  • The Nile tilapia Oreochromis niloticus, Atlantic salmon Salmo salar, rainbow trout Oncorhynchus mykiss, olive flounder Paralichthys olivaceus, common carp Cyprinus carpio, grass carp Ctenopharyngodon idella and rohu carp Labeo rohita are farmed commercially worldwide. Production of these important finfishes is rapidly expanding, and intensive culture practices can lead to stress in fish, often reducing resistance to infectious diseases. Antibiotics and other drugs are routinely used for the treatment of diseases and sometimes applied preventatively to combat microbial pathogens. This strategy is responsible for the emergence and spread of antimicrobial resistance, mass killing of environmental/beneficial bacteria, and residual effects in humans. As an alternative, the administration of probiotics has gained acceptance for disease control in aquaculture. Probiotics have been found to improve growth, feed utilization, immunological status, disease resistance, and to promote transcriptomic profiles and internal microbial balance of host organisms. The present review discusses the effects of single and multi-strain probiotics on growth, immunity, heamato-biochemical parameters, and disease resistance of the above-mentioned finfishes. The application and outcome of probiotics in the field or open pond system, gaps in existing knowledge, and issues worthy of further research are also highlighted.

인삼다당체 진산과 유사구조 다당체의 면역증강활성작용 (Comparison between Immunostimulatory Activity and Molecular Structure of Different Polysaccharides)

  • 심지영;정인성;김찬화;윤연숙;송지영
    • IMMUNE NETWORK
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    • 제4권2호
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    • pp.94-99
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    • 2004
  • Background: We previously reported that ginsan, a polysaccharide extracted from Panax ginseng had an immunostimulatory activity such as mitogenic activity, activation of macrophages and killer cells, and production of a variety of cytokines which resulted in antitumor and antiseptic effects. We further purified $\alpha$-(1$\longrightarrow$6)-glucan and $\beta$-(2$\longrightarrow$6)-fructan from the ginsan with size exclusion and ion-exchange column chromatography successively. In this study, we performed the structure-based activity of ginsan by comparison with known polysacchrides such as $\beta$-glucan, curdlan, laminarin, levan, dextran, lentinan and OK-432. Methods: To investigate the immunostimulatory activity of several polysaccharide compounds, we investigated the stimulation of lymphocytes proliferation, the generation of activated killer cells and the secretion of nitrites from activated macrophages. Results: Of polysaccharides tested, curdlan and ginsan stimulated lymphocyte proliferation, suggesting that the molecular weight and composition of polysaccharide are dependent on the mitogenic activity. The production of nitric oxide was significantly increased in curdlan, levan, ginsan and its fraction, indicating that fructan has also capacity to activate macrophages and may devote to kill pathogens. In addition, the activation of macrophages was seemed to be independent of molecular weight of polysaccharide. The generation of AK cells was exhibited in order of curdlan, OK-432> F1, ginsan, F3> levan> etc. The AK activity may be dependent on molecular weight and composition of polysaccharides. Conclusion: Unfortunately, purified polysaccharide from ginsan were less active on immunostimulatory activity than mixed compounds of polysaccharides. From the viewpoint of structure and activity relationships, we found several characteristic features.

다품목 공용 제약설비인 바이알 충전기에 대한 세척공정 밸리데이션 (Cleaning Validation Studies for Multi-Purpose Facility : Vial Filling Machine)

  • 최한곤;양호준;김영란;성준호;황마로;김종오;용철순
    • 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.

Three-Dimensional Skin Tissue Printing with Human Skin Cell Lines and Mouse Skin-Derived Epidermal and Dermal Cells

  • Jin, Soojung;Oh, You Na;Son, Yu Ri;Kwon, Boguen;Park, Jung-ha;Gang, Min jeong;Kim, Byung Woo;Kwon, Hyun Ju
    • Journal of Microbiology and Biotechnology
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    • 제32권2호
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    • pp.238-247
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    • 2022
  • Since the skin covers most surfaces of the body, it is susceptible to damage, which can be fatal depending on the degree of injury to the skin because it defends against external attack and protects internal structures. Various types of artificial skin are being studied for transplantation to repair damaged skin, and recently, the production of replaceable skin using three-dimensional (3D) bioprinting technology has also been investigated. In this study, skin tissue was produced using a 3D bioprinter with human skin cell lines and cells extracted from mouse skin, and the printing conditions were optimized. Gelatin was used as a bioink, and fibrinogen and alginate were used for tissue hardening after printing. Printed skin tissue maintained a survival rate of 90% or more when cultured for 14 days. Culture conditions were established using 8 mM calcium chloride treatment and the skin tissue was exposed to air to optimize epidermal cell differentiation. The skin tissue was cultured for 14 days after differentiation induction by this optimized culture method, and immunofluorescent staining was performed using epidermal cell differentiation markers to investigate whether the epidermal cells had differentiated. After differentiation, loricrin, which is normally found in terminally differentiated epidermal cells, was observed in the cells at the tip of the epidermal layer, and cytokeratin 14 was expressed in the lower cells of the epidermis layer. Collectively, this study may provide optimized conditions for bioprinting and keratinization for three-dimensional skin production.

Trends in Monoclonal Antibody Production Using Various Bioreactor Systems

  • Jyothilekshmi, I.;Jayaprakash, N.S.
    • Journal of Microbiology and Biotechnology
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    • 제31권3호
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    • pp.349-357
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    • 2021
  • Monoclonal antibodies are widely used as diagnostic reagents and for therapeutic purposes, and their demand is increasing extensively. To produce these proteins in sufficient quantities for commercial use, it is necessary to raise the output by scaling up the production processes. This review describes recent trends in high-density cell culture systems established for monoclonal antibody production that are excellent methods to scale up from the lab-scale cell culture. Among the reactors, hollow fiber bioreactors contribute to a major part of high-density cell culture as they can provide a tremendous amount of surface area in a small volume for cell growth. As an alternative to hollow fiber reactors, a novel disposable bioreactor has been developed, which consists of a polymer-based supermacroporous material, cryogel, as a matrix for cell growth. Packed bed systems and disposable wave bioreactors have also been introduced for high cell density culture. These developments in high-density cell culture systems have led to the monoclonal antibody production in an economically favourable manner and made monoclonal antibodies one of the dominant therapeutic and diagnostic proteins in biopharmaceutical industry.

Glyco-engineering of Biotherapeutic Proteins in Plants

  • Ko, Kisung;Ahn, Mi-Hyun;Song, Mira;Choo, Young-Kug;Kim, Hyun Soon;Ko, Kinarm;Joung, Hyouk
    • Molecules and Cells
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    • 제25권4호
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    • pp.494-503
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    • 2008
  • Many therapeutic glycoproteins have been successfully generated in plants. Plants have advantages regarding practical and economic concerns, and safety of protein production over other existing systems. However, plants are not ideal expression systems for the production of biopharmaceutical proteins, due to the fact that they are incapable of the authentic human N-glycosylation process. The majority of therapeutic proteins are glycoproteins which harbor N-glycans, which are often essential for their stability, folding, and biological activity. Thus, several glyco-engineering strategies have emerged for the tailor-making of N-glycosylation in plants, including glycoprotein subcellular targeting, the inhibition of plant specific glycosyltranferases, or the addition of human specific glycosyltransferases. This article focuses on plant N-glycosylation structure, glycosylation variation in plant cell, plant expression system of glycoproteins, and impact of glycosylation on immunological function. Furthermore, plant glyco-engineering techniques currently being developed to overcome the limitations of plant expression systems in the production of therapeutic glycoproteins will be discussed in this review.

Gata6 in pluripotent stem cells enhance the potential to differentiate into cardiomyocytes

  • Yoon, Chang-Hwan;Kim, Tae-Won;Koh, Seok-Jin;Choi, Young-Eun;Hur, Jin;Kwon, Yoo-Wook;Cho, Hyun-Jai;Kim, Hyo-Soo
    • BMB Reports
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    • 제51권2호
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    • pp.85-91
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    • 2018
  • Pluripotent stem cell (PSC) variations can cause significant differences in the efficiency of cardiac differentiation. This process is unpredictable, as there is not an adequate indicator at the undifferentiated stage of the PSCs. We compared global gene expression profiles of two PSCs showing significant differences in cardiac differentiation potential. We identified 12 up-regulated genes related to heart development, and we found that 4 genes interacted with multiple genes. Among these genes, Gata6 is the only gene that was significantly induced at the early stage of differentiation of PSCs to cardiomyocytes. Gata6 knock-down in PSCs decreased the efficiency of cardiomyocyte production. In addition, we analyzed 6 mESC lines and 3 iPSC lines and confirmed that a positive correlation exists between Gata6 levels and efficiency of differentiation into cardiomyocytes. In conclusion, Gata6 could be utilized as a biomarker to select the best PSC lines to produce PSC-derived cardiomyocytes for therapeutic purposes.