• Title/Summary/Keyword: biopharmaceutical industry

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Recent NMR developments for pharmaceutical research

  • Lee, Kwanghwan
    • Journal of the Korean Magnetic Resonance Society
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    • v.20 no.1
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    • pp.27-35
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    • 2016
  • NMR spectrometer has been regarded as essential tool for structure elucidation in variable scientific field as like organic synthesis, natural product and macro protein research. Also NMR can be applied for defining dynamic behavior like ligand and receptor binding. One of advantage of research with NMR is that to be great confident to confirm structure and the measured sample could be recovered. Nevertheless NMR also has a weak points than other spectroscopic methods that require a lot of time for interpreting acquired spectrum and running time due to low sensitivity. For last two decade Bruker has developed hardware and software solution for overcome those weak points. In order to overcome low sensitivity Bruker introduced Cryo and Micro diameter probe head technology. And researcher can reduce the time for routine spectrum processing and interpretation works due to lots of introductions in software solutions for quantification, identification and statistics analysis. With four examples, this article describing those new hardware and software solutions in field of recent pharmaceutical research as follows. - New Horizons for NMR in the Biopharmaceutical Industry - The development and application of solid-state NMR spectroscopy (SSNMR) in pharmaceutical analysis - Assisted NMR Data Interpretation in Synthetic Chemistry - Complete Analysis of New Psychoactive Substances Using NMR.

In-Vitro Refolding of PEGylated Lipase (PEGylation된 Lipase의 In-Vitro 재접힘)

  • Kim, Min-Young;Kwon, Jin-Sook;Lee, Eun-Kyu
    • KSBB Journal
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    • v.20 no.5 s.94
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    • pp.338-340
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    • 2005
  • Covalent modification of a protein with polyethylene glycol (PEG) has become one of the most widely used and well established drug enhancement strategies in the biopharmaceutical industry. The general benefits enjoyed by PEGylation, such as prolonged serum half-lives or reduced immunogenicity in vivo, are well known. By now the PEGylation process has been performed with purified proteins, and it is required to recover the desired PEGylate by a multi-step purification process. The ultimate aim of our research is to develop an integrated process of PEGylation and in vitro refolding starting with inclusion body material. For this, we investigated the feasibility that a protein could be PEGylated under a denaturing condition and also the PEGylated proteins could be refolded correctly. Using lipase as a model protein, we found that it was PEGylated in the presence of 8M urea and that the PEG molecules covalently attached to lipase did not appear to hinder its refolding.

Trends in Monoclonal Antibody Production Using Various Bioreactor Systems

  • Jyothilekshmi, I.;Jayaprakash, N.S.
    • Journal of Microbiology and Biotechnology
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    • v.31 no.3
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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.

Virus Purification by Membrane Chromatography: A Review (멤브레인 크로마토그래피에 의한 바이러스 정제 : 리뷰)

  • Gayatri Bhamidipatia;Rajkumar Patel
    • Membrane Journal
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    • v.34 no.2
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    • pp.124-131
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    • 2024
  • Viruses have various applications in the biopharmaceutical industry. They are used in pesticide production, production of vaccines, gene transfers, cancer therapeutics, and more. The downstream processing of viruses is an essential step for their biological and pharmaceutical applications. Among the various processes, the purification of viruses is critical. Membrane chromatography plays a vital role in this process. While ion exchange membrane chromatography is a primarily used method, it has various limitations regarding size exclusion and insufficient purification. Also, it cannot be applied to the rapidly changing strains of viruses such as influenza. This review examines various improved methods of membrane chromatography or alternatives. It focuses on purification, viral recovery rates, and scalability of the methods.

A Study on the Visual Characteristics of Korean Pharmaceutical Companies' CI Symbol Marks (국내 제약회사 심벌마크의 시각적 특징 연구)

  • Hong, Il-Yang
    • The Journal of the Korea Contents Association
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    • v.16 no.9
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    • pp.443-450
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    • 2016
  • Korean biopharmaceutical industry is a high value-added industries of the country as a key business strategy of the country. The overseas market is accelerating rapidly due to drug demand according to population aging, new drug R&D investment performance visualization, changes in biopharmaceutical R&D center, strategic foreign technology exports, and the active support of government. Therefore, the domestic pharmaceutical companies also should enhance the competitiveness as global pharmaceutical companies and need to build the image of their own company that can be trusted by consumers. This study compared and analyzed visual characteristics shown in the CI symbol mark and age-specific preferences of domestic pharmaceutical companies recognizing the importance of CI as a marketing tool. As a result, preference for the symbol mark had been shown to be significantly higher preference of the old logotype as the age group is higher being proportional to awareness. In addition, the picture-type symbol mark was totally preferred rather than the word mark. Among the picture-type symbol mark, the form of the nature was strongly preferred rather than abstract form. The company also requires a sense of responsibility for recognizing changes in the mass to the globalization. It is hoped that this study will help to develop symbol mark direction as the basis for the identity strategies to improve the image of domestic pharmaceutical companies with global competitiveness.

An Empirical Study on the Influence of the Selection Factors of the Cold Chain Third Party Logistics Companies on Satisfaction (의약품 콜드체인 3자 물류업체의 선정요인이 만족도에 미치는 영향에 관한 실증연구)

  • Sun, Il-Suck;Ahn, Sung-Jin
    • 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.

Evaluation of Viral Inactivation Efficacy of a Continuous Flow Ultraviolet-C Reactor (UVivatec) (연속 유동 Ultraviolet-C 반응기(UVivatec)의 바이러스 불활화 효과 평가)

  • Bae, Jung-Eun;Jeong, Eun-Kyo;Lee, Jae-Il;Lee, Jeong-Im;Kim, In-Seop;Kim, Jong-Su
    • Microbiology and Biotechnology Letters
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    • v.37 no.4
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    • pp.377-382
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    • 2009
  • Viral safety is an important prerequisite for clinical preparations of all biopharmaceuticals derived from plasma, cell lines, or tissues of human or animal origin. To ensure the safety, implementation of multiple viral clearance (inactivation and/or removal) steps has been highly recommended for manufacturing of biopharmaceuticals. Of the possible viral clearance strategies, Ultraviolet-C (UVC) irradiation has been known as an effective viral inactivating method. However it has been dismissed by biopharmaceutical industry as a result of the potential for protein damage and the difficulty in delivering uniform doses. Recently a continuous flow UVC reactor (UVivatec) was developed to provide highly efficient mixing and maximize virus exposure to the UV light. In order to investigate the effectiveness of UVivatec to inactivate viruses without causing significant protein damage, the feasibility of the UVC irradiation process was studied with a commercial therapeutic protein. Recovery yield in the optimized condition of $3,000\;J/m^2$ irradiation was more than 98%. The efficacy and robustness of the UVC reactor was evaluated with regard to the inactivation of human immunodeficiency virus (HIV), hepatitis A virus (HAV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), porcine parvovirus (PPV), bovine parvovirus (BPV), minute virus of mice (MVM), reovirus type 3 (REO), and bovine parainfluenza virus type 3 (BPIV). Non enveloped viruses (HAV, PPV, BPV, MVM, and REO) were completely inactivated to undetectable levels by $3,000\;J/m^2$ irradiation. Enveloped viruses such as HIV, BVDV, and BPIV were completely inactivated to undetectable levels. However BHV was incompletely inactivated with slight residual infectivity remaining even after $3,000\;J/m^2$ irradiation. The log reduction factors achieved by UVC irradiation were ${\geq}3.89$ for HIV, ${\geq}5.27$ for HAV, 5.29 for BHV, ${\geq}5.96$ for BVDV, ${\geq}4.37$ for PPV, ${\geq}3.55$ for BPV, ${\geq}3.51$ for MVM, ${\geq}4.20$ for REO, and ${\geq}4.15$ for BPIV. These results indicate that UVC irradiation using UVivatec was very effective and robust in inactivating all the viruses tested.