A study on methodology for trend analysis and technology forecasting using unstructured patent data and natural language processing : focused on case of biopharmaceutical field

김시우 차의과학대학교 일반대학원 2022 국내석사

4차 산업혁명 시대에서 기술예측은 과학과 경제발전을 효과적으로 연결할 수 있고 다양한 미래 상황에 대비할 수 있다. 객관적인 데이터의 평가를 통한 과학적 근거에 기반한 기술 개발 전략 및 연구개발 방향을 설정하는 것은 과학 산업분야에서 주요 이슈가 되어 왔다. 현재 대부분의 국가에서 특허 제도가 확립되어 있다. 과학 산업분야의 연구자들은 본 출원공개 제도를 통해 연구와 투자의 중복을 방지하고 효과적인 연구개발 방향을 설정할 수 있다. 특허 데이터는 전 세계적으로 연간 약 3백만 건이 출원되고 있으며 이는 빅 데이터의 성격을 가지고 있다. 특허 데이터의 종류는 정형 데이터와 비정형 데이터가 있다. 특허 데이터는 공백 또는 유망기술을 도출하는 등 기술예측을 위한 데이터 소스로 사용될 수 있다. 기술예측을 위한 다양한 특허분석 방법론이 연구되어 왔다. 출원일, 출원인, 국가 코드, IPC code, CPC code 등의 정형 데이터를 이용한 특허분석 방법론들은 과학 산업의 첨단 기술을 분석하고 의미 있는 연구개발 방향을 제시하기 어렵다는 한계점이 존재한다. 또한, 특허 분석 결과는 산업 분야의 실질적인 니즈와 간극이 존재한다. 이를 극복하기 위해, 제목, 초록, 청구항 등 비정형 특허 데이터를 적극적으로 활용할 수 있는 방법론이 요구된다. 그러나 비정형 특허 데이터는 거대한 텍스트 코퍼스 형태로 존재하기 때문에 활용하기가 쉽지 않다. 이 비정형 특허 데이터를 분석하기 위해 자연어 처리 기법을 이용한 특허 분석 방법론이 제안되고 있다. 딥러닝 기반의 자연어 처리 기법은 기계 학습을 위한 훈련 데이터 세트가 필요하다. 그러나 이 훈련 데이터 세트를 준비하는 것은 어렵고 제공되고 있는 데이터 세트도 제한적이다. 본 연구에서는 산업분야의 실질적인 니즈와의 간극을 최소화하고 비정형 특허 데이터를 체계적으로 분석하기 위한 두 가지 특허 분석 방법론을 제안하였다. 제안된 방법론들을 검증하기 위해, 바이오의약품 분야에 적용하였다. 바이오의약품 분야는 신물질 발굴부터 신약개발까지 높은 투자가치와 고액의 자금과 장기투자가 가능한 지식기반 산업이다. 방법론 적용 결과, 바이오의약품 분야의 특허 데이터를 기반으로 동향 분석이 가능하였고, 공백 및 유망기술을 도출할 수 있었다. In the era of 4th industrial revolution, technology forecasting can effectively link science and economic development and prepare for various future situations. Establishing directions for R&D management and strategy for the development of technology based on scientific evidence through the evaluation of objective data has been a major issue in the scientific industry. Patent systems are now established in most countries. Researchers in the scientific industry can prevent overlapping R&D research and investment and set effective R&D directions through this application disclosure system. Patent data are filed about 3 million annually worldwide, and it has the characteristics of big data. There are two types of patent data: structured data and unstructured data. Patent data can be used as a data source for technology forecasting such as deducing vacant or promising technologies. Various patent analysis methodologies have been studied for technology forecasting. Patent analysis methodology using structured data such as application date, applicant, country code, IPC code and CPC code has limitations in that it is difficult to analyze advanced technologies in the scientific industry and suggest a meaningful R&D direction. Also, results of patent analysis have gaps with the practical needs of the industry. To overcome this, methodoloeis that can actively utilize unstructured patent data such as title, abstract, and claims is required. However, it is not easy to utilize unstructured patent data due to exist in the form of a big text corpus. Patent analysis methodologies using natural language processing techniques have been proposed to analyze unstructured patent data. Natural language processing techniques based on deep learning requires a training data set for machine learning. However, it is difficult to prepare this training data set and the provided data set is also limited. In this study, we proposed two patent analysis methodologies to minimize the gap with practical needs in the industrial field and systematically analyze unstructured patent data. To verify the proposed methodologies, we applied them to the field of biopharmaceuticals. The biopharmaceutical field is a knowledge-based industry with high investment value and a large amount of money and long-term investment from the discovery of new substances to the development of new drugs. As a result of applying methodologies, based on patent data in the field of biopharmaceuticals, trends analysis was possible and vacant and promising technologies could be deduced.

Evaluation of international regulatory harmonization of domestic data integrity guidelines : focusing on MFDS, FDA, EMA, MHRA & PIC/S

최현정 중앙대학교 대학원 2024 국내석사

Preparation and characterization of polyethersulfone microfiltration membranes and lateral flow nitrocellulose membrane

박성률 중앙대학교 대학원 2023 국내박사

Biopharmaceuticals are new drugs with fewer side effects and excellent effects on the human body, and are beyond the physical and chemical limitations of existing synthetic drugs. Korea is growing as a center of biopharmaceuticals. Celltrion developed the world's first commercial biosimilar, Samsung Biologics became the world's largest contract manufacturing company, and Songdo became a global production base for biopharmaceuticals. A lot has changed since the outbreak of COVID-19 in 2019, and Korea has become the country that produces the most antigen kits for rapid diagnosis. Behind the growth of the bio industry was the rapid growth of biophar- maceuticals and the common sense of in vitro diagnostic kits. Another side of these products was the issue of essential parts for production. In biophar- maceuticals, microfiltration (MF) and ultrafiltration (UF) membranes played a key role in the downstream process, but in Korea, there was a problem in that they depended entirely on imports and could not escape from the oligopoly of certain companies. Another one is an in vitro diagnostic kit, which is a lateral flow nitrocellulose (LFNC) membrane, and is also facing a lack of supply and new technology development in the form of an oligopoly of a specific company. PES is originally a hydrophobic material, but more hydrophilic among hydrophobic materials, so it is widely used as a material for filtration and is also most widely used as a membrane material for biopharmaceuticals. In this study, by increasing the hydrophilicity of PES, It would be tried to prevent proteins and bio burden materials from being attached to the membrane and to increase flux. As a result, it was intended to derive benefits by reducing the area used for the membrane, saving energy, and saving process time. Developing a sulfonated polyethersulfone (sPES) material and producing a blended membrane with a ratio of PES/sPES of 12:1, it contributes to the performance improvement such as advantage of hydrophilic, and by manufacturing it into a finished bottle top filter product with a 500 ml funnel, it is used domestically and internationally. As compared with existing products, the best performance of 27,829 L/m2/hr was obtained while having the same pores of 0.2 um. In addition, by using dimethyl sulfoxide (DMSO), it was possible to develop the most eco-friendly product based on the LD50 of 14,500 MPK to the rat. By increasing the PES/sPES ratio from 12:1 to 12:3, the development of a membrane with better hydrophilicity and improved flux is a future plan. In addition, we will accelerate the development of membranes for biopharmaceuticals by expanding from bottle top filters and applying them to capsules and cartridge filters. In the case of LFNC, based on the material characteristics of nitrocellulose, the control of solid content and the characteristics according to the change of solid content were statistically approached through 565 pilot scale studies. As the solid content increased, the thickness and wicking rate increased, and this was also shown in the content of water, one of the additives. The correlation between the thickness and the wicking rate was investigated and it was observed that the wicking rate improved as the thickness increased. An anionic surfactant was used as a way to give hydrophilicity to nitrocellulose, which is basically hydrophobic, and it was confirmed that the number of pores on the surface increased as sodium dodecyl sulfate (SDS) was added. It was observed that the wicking rate also decreased as the thickness decreased. In addition, an increase in the content of SDS give disadvantage to the dispensing characteristics. Theoretically, the dispensing solution should be fixed vertically from the surface to the bottom of the membrane. If the solution would be diffused horizontally due to hydrophilicity, the color development is going to bad consequence like light color development as result of lower sensitive than vertical dispensing. Since dispensing and color development could not be accessed numerically, a relative comparison with Sartorius' cellulose nitrate (CN) 110 product was studied. The CN110 product has a thickness of around 100 um and takes 110 seconds to transfer to 40 mm, but in this study, the thickness was adjusted to CN110, but the wicking rate was 140 seconds, based on the CN140 product. The 220830-1 product was able to secure the target physical and biological equivalence in terms of performance with a thickness of around 100 um and a wicking rate of around 140 seconds based on the Sartorius CN product. The future plan is to statistically analyze the results of 565 studies and making a higher wet thickness to increase the dry thickness as thicker as the CN140 about 250 um and create a stable and excellent product while matching the wicking rate as faster as CN110 about 110 seconds. Referring to this study, dispensing characteristic, color development, and role of each material identified to the fabricating process will be utilized to enable successful follow-up research. 바이오 의약품은 인체에 부작용이 적고, 효과는 우수한 신약이며, 기존의 합성 의약품이 가지고 있는 물리, 화학적인 한계를 넘어서고 있다. 한국은 바이오 의약품의 중심지로 성장하고 있는데, 셀트리온은 세계 최초로 상업적으로 바이오 시밀러를 개발했으며, 삼성바이오로직스는 세계 최대규모 위탁생산 업체가 되었고, 이를 중심으로 송도는 바이오 의약품의 세계적인 생산기지가 되었다. 2019년 COVID-19가 발생한 이후로 많은 변화가 있었는데, 한국은 가장 많은 신속진단용 항원키트를 만들어내는 국가가 되었다. 바이오 산업의 성장 이면에 바이오 의약품의 비약적인 성장, 체외진단키트의 일상화가 있었는데, 이러한 제품의 또 다른 이면에는 생산을 위한 필수 부품에 대한 이슈가 있었다. 그것은 바이오 의약품에서는 microfiltration (MF), ultrafiltration (UF) membrane이 down stream 공정의 핵심적인 역할을 하고 있었지만, 한국에서는 전량 수입에 의존하며, 특정 업체의 과점 형태에서 벗어나지 못하고 있다는 문제가 있었다. 또 다른 하나는 체외진단키트이며, lateral flow nitrocellulose (LFNC) membrane이 그것이고, 또한 특정 업체의 과점 형태에서 공급부족, 새로운 기술개발의 부족에 직면하고 있다. PES는 본래 소수성 소재이나, 소수성 소재 중에서는 친수성이 우수한 편에 속하여 여과용 소재로 널리 활용되고 있고, 바이오 의약품용 멤브레인 소재로써도 가장 널리 사용되고 있다. 본 연구에서는 PES에 친수성을 더 높임으로써 단백질 및 얻고자 하는 물질의 멤브레인에의 부착을 방지하는 기능을 개선하고, flux를 높임으로써 사용 면적을 줄이고, 에너지를 절감하며 공정 시간을 절약함으로써 편익을 도출해 내고자 하였다. 그 과정에서 sulfonated polyethersulfone (sPES)소재를 개발하여, PES/sPES를 12:1의 비율로 blended membrane을 만들어 냄으로써 목표한 성능개선에 기여하고, 이를 500 ml funnel을 가진 보틀탑 필터 완제품으로 제작함으로써 국내외 기존 제품들과 비교함에 따라, 0.2 um의 기공을 똑같이 가지면서도 27,829 L/m2/hr의 가장 우수한 성능을 얻을 수 있었다. 뿐만 아니라, 최초의 개발 단계에서 dimethyl sulfoxide (DMSO)를 사용함으로써 14,500 MPK의 LD50을 바탕으로 가장 친환경적인 제품으로 개발할 수 있었다. PES/sPES의 비율을 12:1 에서 12:3까지 높여감으로써, 친수성이 더 우수하고 flux가 개선된 membrane에 대한 개발은 향후 계획이다. 또한 보틀탑 필터에서 확장하여 캡슐, 카트리지 필터에 적용함으로써 바이오 의약품용 membrane의 개발에 박차를 가할 것이다. LFNC의 경우 nitrocellulose의 소재적인 특성을 기초로 고형분의 제어와 고형분의 함량 변화에 따른 특성을 565건의 pilot scale 연구를 통하여 통계적으로 접근하였다. 고형분의 증가에 따라서 두께와 전개속도가 증가하는 결과를 얻었으며, 이는 첨가제 중 하나인 물의 함량에서도 동일하게 나타났다. 두께와 전개속도의 상관관계에 대해서 탐구하여 두께가 높아질수록 전개속도가 향상되는 것을 관찰하였으며, 이는 용액이 기재필름이 움직이는 분당 전개속도 당 분출되는 양이 많아질수록 두께와 전개속도가 모두 증가하는 것을 확인할 수 있었다. 기본적으로 소수성의 성질을 띄는 nitrocellulose의 친수성을 부여해줄 수 있는 방안으로 음이온 계면활성제를 사용하였으며, sodium dodecyl sulfate (SDS)를 첨가할수록 표면의 기공의 수가 증가하는 것을 확인하였으나, 이 경우 용액의 점도를 떨어트리고 두께 역시 감소함에 따라 전개속도도 감소하는 것을 관찰할 수 있었다. 뿐만 아니라, SDS의 함량 증가는 분주 특성을 저해시키는데, 가장 대표적으로는 분주된 용액이 멤브레인의 표면에서 바닥으로 수직방향으로 고정되어야 하는데, 친수성에 의해 수평방향으로 확산되는 현상을 나타냄으로써, 결과적으로 발색에서도 색이 연한 발색을 나타내게 되는 효과를 나타냄을 확인할 수 있었다. 분주와 발색은 수치적인 접근을 할 수 없었기 때문에 상대적인 비교를 눈으로 Sartorius 사의 cellulose nitrate (CN) 110 제품과 동등 비교할 수 밖에 없었는데, 220830-1의 제품은 CN110과 동등한 수준의 성능을 나타냄을 확인할 수 있었다. CN110 제품은 100 um 내외의 두께와 40 mm 전개에 110초 소요되는 제품이나, 이번 연구에서는 두께는 CN110에 맞추되 전개속도는 140초로써 CN140 제품을 기준으로 하였다. 220830-1 제품은 두께 100 um내외, 전개속도 140초 내외로 성능적으로 목표하는 물리적, 생물학적 동등성을 Sartorius CN 제품을 기초로 확보할 수 있었다. 향후 계획으로는 565개의 연구결과를 통계적으로 분석하여 코팅 두께를 높게 유지함으로써 CN140이 가지는 두께 약 250 um 수준까지 높이면서 전개속도는 110초인 CN110 제품에 맞추면서, 안정적이고도 우수한 제품을 만들어내는 것이다. 그 과정에서 동 연구과정에서 확인한 분주, 발색, 각 소재별 특성이 활용되어 성공적인 후속연구가 가능할 것이다.

Development of ion conducting polyurethane-urea polymers for cold-chain pharmaceutical storage applications

Hong, Okbi Sungkyunkwan University 2025 국내석사

Pharmaceutical cold-chain logistics require selective and accurate temperature sensors for each product at low temperatures to ensure the safe transport and stability of temperature-sensitive drugs. Current sensors used for these applications are not able to detect the temperature of individual products due to high cost and material limitations, posing a significant challenge for biopharmaceutical logistics. To address this, we developed a novel ion-conducting polymer matrix based on poly(urethane-urea), designed specifically for low-temperature environments. Poly(urethane-urea) derivatives with varying molecular weights and hard segment contents were synthesized and characterized using electrochemical impedance spectroscopy to evaluate their resistance. The optimized polymer demonstrated hyteresis after exposure at temperatures around 30 °C with conductivity of approximately 10-6 S/cm, which is suitable for improving safety in cold-chain systems. These findings highlight the potential of ionically conductive polymers to extend the operational range of pharmaceutical storage materials, providing a promising solution for the secure and effective transport of sensitive low-temperature biopharmaceuticals.

Research on Influencing Factors of Cluster Competitiveness of Biopharmaceutical Industry in China : A Case of Yangtze River Delta

주문영 세한대학교 대학원 2024 국내박사

The biopharmaceutical industry, emblematic of cutting-edge high-tech sectors, has emerged as one of the fastest-growing industries in the global economy. Propelled by demographic aging, the upgrading of consumer preferences toward healthcare, recent policy directives, China's biopharmaceutical industry is demonstrating a trajectory of high-quality development. As a knowledge-intensive sector, the industry, particularly in processes like technological innovation and drug development, heavily relies on collaboration with relevant enterprises and institutions. This collaborative nature has fostered the naturally occurring regional clustering of China's biopharmaceutical industry. Presently, the biopharmaceutical industry in China has coalesced into four major pharmaceutical industry clusters: the Bohai Rim, Yangtze River Delta, Pearl River Delta, and Chengdu-Chongqing metropolitan regions. Among these, the Yangtze River Delta pharmaceutical industry holds a leading domestic position, with approximately one-fourth of the nation's enterprises and workforce. Aligned with the national directives articulated in the "Establishment of a World-Class Biopharmaceutical Industry Cluster in the Yangtze River Delta" strategy of 2020 and the "Outline of 2035," the role of the Yangtze River Delta's biopharmaceutical industry as a pinnacle is becoming increasingly prominent. The development of its industrial cluster competitiveness bears significant implications for advancing national strategic emerging industries and elevating the international standing of China's biopharmaceutical industry. This research focuses on the biopharmaceutical industry cluster in the Yangtze River Delta, employing the renowned GEM model as an analytical framework for cluster competitiveness. Utilizing research methods such as factor analysis and regression analysis, the study unfolds across three dimensions: Firstly, it theoretically elucidates the mechanisms behind cluster competitiveness. Employing the GEM model, it constructs an evaluation indicator system for the competitiveness of the biopharmaceutical industry cluster. By selecting development data from 2015 to 2022 for the biopharmaceutical industry in the four provinces and one municipality in the Yangtze River Delta, the study employs factor analysis to comprehensively assess the competitiveness of the biopharmaceutical industry cluster across six dimensions: resources, facilities, enterprises, auxiliary industries, domestic markets, and overseas markets. Secondly, this study combines the meso-level of each cluster and the micro-level of enterprises to comprehensively analyze the influencing factors of cluster competitiveness in the pharmaceutical industry according to three different levels such as the overall cluster, enterprise scale, and different regions. It also compares the differences in cluster competitiveness among different scales and regions. Thirdly, this research focuses on the key factors of R&D investment in the competitiveness of the biopharmaceutical industry. Through a three-tier approach, it comprehensively analyzes the influencing factors of R&D investment and compares the heterogeneity of R&D investment among different regions. Based on the regression analysis results and the developmental characteristics of the Yangtze River Delta biopharmaceutical industry, this paper proposes strategies to enhance the cluster competitiveness of the biopharmaceutical industry. Keywords: Biopharmaceutical Industry; Cluster Competitiveness; Yangtze River Delta; GEM Model.

한국 바이오제약 산업의 기업효율성과 개방형혁신 영향 분석

노윤길 충북대학교 2024 국내박사

The biopharmaceutical industry has a high future growth potential, characterized by enormous R&D investment, high risk and high return, strict regulations by regulators and the occurrence of economies of scale at the global market level. The biopharmaceutical companies that are in the nature of the R&D-oriented and state-controlled industry have come to seek new and diverse business models to efficiently develop products. In addition, Biopharmaceutical companies has increasingly embraced open innovative R&D models, moving away from the existing closed R&D approach. In response to recent changes in the external environment, this study was classified Korea biopharmaceutical companies by business modes and was analyzed the corporate efficiency. Next, by checking the trend of changes in corporate efficiency by business model, the change in corporate efficiency was analyzed during the analysis period. Finally, the factors affecting corporate efficiency were analyzed from an open innovation perspective to analyze which innovation activities affect corporate efficiency. The analysis data was from 2015 to 2021 of the ‘Bio Industry Survey’ conducted by the Korea Biotechnology Industry Organization (KBIO) every year through surveys, and the actual analysis was analyzed from 2018 to 2021 reflecting the three-year performance lag. First, Korea biopharmaceutical companies were classified into an ‘Integrated business model group’ that combines production and research, and a ‘R&D focused business model group’ that generates profits by focusing on research. As a result of analyzing corporate efficiency using the DEA analysis method, the R&D focused business model group was analyzed to be more efficient than the Integrated business model group and the comparison by size was analyzed to be highly efficient for companies with large sales. Next, Korea biopharmaceutical companies based on business model was checked Malmquist productivity index, as a result, during the analysis period, including the period when COVID-19 was severe, Korea biopharmaceutical companies saw their overall efficiency increase. However, this efficiency was analyzed to have a greater impact on internal management such as management efficiency than technological innovation. Finally, Tobit analysis was conducted to confirm the factors affecting this efficiency from an open innovation perspective and among the open innovation types, non-technical cooperation types were found to have a positive (+) effect on corporate efficiency rather than technological cooperation types. In individual activities, it was confirmed that joint ventures had a positive (+) effect, and joint research had a negative (-) effect. It is judged that three years of R&D time in the biopharmaceutical field is insufficient to confirm its effectiveness. However, because of the analysis based on the start of open innovation, it was confirmed that joint research had a positive (+) effect in some groups, reaffirming that R&D is an area that requires long-term support. Through the above analysis, Korea biopharmaceutical industry was found that R&D focused business model companies were managing more efficiently than Integrated business model companies that produce and research at the same time. And it was confirmed that corporate efficiency needs to be increased by improving sales volume. In addition, it was confirmed that biopharmaceutical companies require intensive investment in R&D, but financial investment is an efficient management strategy rather than R&D that requires long-term resource investment to increase efficiency in the short term. Through this study, we can identify the characteristics of business models and open innovation in the Korea biopharmaceutical industry, and what efforts need to be made to increase the efficiency of the company. Key words: Biopharmaceutical industry, Corporate efficiency, Business model, Open Innovation, DEA, Tobit, Malmquist index

개방형 혁신의 한계와 진화 : 한국제약바이오산업

왕혜주 충북대학교 일반대학원 2025 국내박사

In the COVID-19 pandemic, open innovation is no longer an option but an essential strategic measure for firms in the biopharmaceutical industry. The Covid-19 health emergency has plunged the world into an unprecedented crisis. Certainly, the COVID-19 pandemic has contributed to the development of new strategic partnerships in the biotechnology industry, even in the open innovation model (open innovation alliance). The biopharmaceutical industry has unique characteristics that are different from other technology-intensive industries. This industry is characterized by high complexity and an implicit knowledge-intensive innovation environment, fundamental uncertainty and frequent failures, long development periods and enormous development costs, multidisciplinary nature, continuous emergence of new technologies, and the integrated nature of the R&D process and nonlinear innovation process. These unique characteristics also make open innovation for biopharmaceutical firms no longer an option but an essential strategic measure. Therefore, an integrated study is needed in terms of strategic aspects, operational management aspects, and structural aspects of the network, and this study aims to compare and analyze the results with those of advanced countries by applying them to catching-up countries. First, using data from Korea, one of the most representative latecomer countries in the biopharmaceutical industry, we collected basic information, open innovation activities, and patent performances of Korean biopharmaceutical firms and organized them into a database to examine factors affecting open innovation in the biopharmaceutical industry (government R&D support, absorptive capacity, and alliance management capacity). After excluding samples with missing or incorrect information, we conducted a negative binomial regression analysis on 527 firms, considering the characteristics of the dependent variable, patent performance. The results showed that open innovation in the form of technology cooperation, not technology purchase, had a positive effect on technology innovation performance. Meanwhile, absorptive capacity and government R&D support showed that technology purchase and technology cooperation had a positive moderating effect on technology innovation performance. Alliance management capacity was not significant for the relationship between technology purchase and technology innovation, and conversely, alliance management capacity showed that technology cooperation positively moderated technology innovation. In the first stage, this study examined the impact of inbound open innovation (technology purchase, technology cooperation) and moderating factors (absorptive capacity, government R&D support, and alliance management capability) on technological innovation performance. In the second stage, this study examined the impact of inbound open innovation (technology purchase, technology cooperation) and moderating factors (absorptive capacity, government R&D support, and alliance management capability) on technological innovation performance. In the second stage, this study examined whether they affected outbound open innovation (technology transfer). examined whether they affected outbound open innovation (technology transfer). All of them had a positive impact. This study confirmed that such open innovation does not necessarily lead to positive innovation performance and has limitations under various conditions. In other words, this means that the impact of open innovation activities on technological innovation performance may vary depending on the context. In addition, the biopharmaceutical industry is an implicit knowledge -intensive industry that creates useful synergy effects by utilizing complex and powerful interactions based on science. Accordingly, this study investigated the impact of resources and capabilities on open innovation in the cooperative network composition of the Korean biopharmaceutical industry, one of the latecomers, using data from domestic biopharmaceutical firms. As a result of the analysis, the biopharmaceutical industry in Korea, a latecomer to the biopharmaceutical industry, is different from other industries in that various innovation entities work in a complex and organic manner, overcoming the limitations of previously presented models and interpretations of results and presenting a more innovative model for domestic and foreign biopharmaceutical firms. This study is also significant in that it can contribute to suggesting policies that can strengthen the government's R&D infrastructure and commercialization support to create a biopharmaceutical ecosystem, strengthen the industry-academia-research institute-hospital network, and suggest a step-by-step cooperation model to activate research centered on innovation entities and expand research cooperation between firms, universities, and research institutes, thereby helping biopharmaceutical firms grow into total healthcare firms encompassing prevention-diagnosis- treatment-management Keywords Korean biopharmaceutical industry; R&D intensity, Government R&D subsidy; Alliance management capability; Network configuration. * A thesis for the degree of Doctor in February 2025.

Impact of R&D Network Embeddedness on Innovation Performance of Chinese Biopharmaceutical Firms: Based on the Mediating Role of Knowledge Transfer Capability and Innovation Culture Atmosphere and the Moderating Role of Enterprise Cognition

LIN XIAOLI 국립부경대학교 기술경영전문대학원 2024 국내박사

Analysis of turnover factors of employees by job field in the Biopharmaceutical industry

Park, Jungtae Sungkyunkwan University 2022 국내박사

연구배경: 미래 신성장동력산업으로 관심이 확대되고 있는 바이오제약 산업은 현재 업계의 급격한 발전으로 인해 인력난을 겪고 있으며, 인력 부족의 주된 원인 중의 하나로 종사자들의 잦은 이직이 확인되었다. 특히 이직 발생률이 높은 분야는 생산, 영업/마케팅, 그리고 임상/RA 분야로 이들 3개 분야의 이직의도에 대한 상세하고 포괄적인 이해는 한국의 바이오제약산업 성장에 매우 중요하다고 볼 수 있다. 연구목적: 본 연구는 바이오제약 산업 성장의 핵심 요소인 생산, 영업/마케팅, 임상/RA 분야별 종사자들의 정확한 이직요인을 파악하고 그에 대한 대책을 마련하여 기업의 이직률을 줄이고 기업이 안정적으로 성장을 이룰 기회를 생성, 궁극적으로 바이오제약 산업의 발전에 기반이 되는 틀을 마련하는 것을 그 목적으로 한다. 연구방법: 구글 설문조사 방법을 이용하여 바이오의약품 회사의 생산, 영업/마케팅, 임상/RA 분야에서 일하는 종사자들에 대한 이직요인을 조사하였다. 설문조사는 2020년 9월부터 2020년 10월까지 약 2개월 동안 진행하였고, 설문 대상자는 인구통계학적 변수에 대한 quota를 기준으로 선정하여 국내외 바이오의약품 업체 종사자들을 대상으로 500명을 조사하였다. 설문지 구성은 개인특성관련요인, 직무관련요인, 조직관련요인 등을 고려하여 설정하였으며, 이직의도와 각 요인의 상관관계를 확인하기 위해 다중회귀분석을 실시하였다. 연구결과: 직종별 주요 이직요인으로 생산직 종사자는 조직몰입도 및 감독자에 대한 만족도가 높을수록, 그리고 부양가족의 책임이 낮을수록 이직의도가 낮은 것으로 조사되었다. 영업/마케팅 종사자는 여성보다 남성이 이직의도가 낮고, 또한 중견/대기업에 다니고 있거나, 직무자체 및 봉급에 대한 만족도가 높을수록 이직의도가 낮은 것으로 조사되었다. 임상/RA 종사자는 중견/대기업 종사자일수록, 그리고 직무자체에 대한 만족도가 높을수록 이직의도가 낮은 것으로 확인되었다. 결론: 본 논문에서 바이오제약산업의 직무, 조직, 개인문제를 결합한 다양한 상황에서 3개 직종별 이직요인을 분석하였으며, 연구결과에서 생산,영업/마케팅.임상/RA 각 직종별 이직요인 분석에 차이가 있는 것으로 나타났다, 특히 생산직종은 조직몰입도 및 감독자 그리고 가족부양 책임부분이 이직요인으로 분석되어 영업/마케팅. 임상/RA 의 주요 이직요인인 중견/대기업 근무여부, 직무자체의 만족도 와는 다르게 분석되었으며, 또한 영업/마케팅은 추가적으로 성별에 따라, 봉급 만족도에 따라 이직요인에 차이가 있는 것으로 분석 되었다 이와같이 3개 분야별 이직요인 분석에 차이가 있기 때문에 이직율을 줄이기 위해서 각 직종별 종사자들의 이직의도 요인 해소를 위한 needs를 파악하고 차별적인 방안수립이 필요하다. 본 연구의 결과를 바탕으로 바이오제약 기업에서 발생하는 이직의 주된 요인을 확인하고 이직률을 줄일 수 있는 적절한 방안을 수립하여, 기업이 안정적으로 성장할 수 있는 기틀을 제공할 수 있을 것으로 기대한다. Background: The biopharmaceutical industry is rapidly growing due to persistent and ever-increasing demand for medical products and an aging population. The rapid growth of the biopharmaceutical industry inevitably demands an increase in the highly skilled workforce. Recruiting and maintaining professional workers is mandatory in three areas that dictate the growth and success of an organization, namely production, sales/marketing, and clinical/RA. However, these fields have the highest turnover rate among other fields in biopharmaceutical industry and thus a detailed and comprehensive understanding of turnover intentions in these fields is very important for the growth of the Korean biopharmaceutical industry. Purpose: This work aims to contribute to the growth and development of the domestic pharmaceutical industry by suggesting correct improvement measures and strategies for employees in the fields of production, sales/marketing, and clinical/RA, to reduce unnecessary turnover and helping the companies to optimize their HR management Method: Google survey was used to find the turnover factors of employees working in three fields. The survey was conducted from September 2020 to October 2020, and 500 survey participants were selected from domestic and foreign biopharmaceutical companies, based on their demographic variables. The composition of the questionnaire was set in consideration of turnover intention factors related to individual characteristics, job-related factors, and organization-related factors. Multiple regression analysis was performed to confirm the significant correlation between turnover intention and each turnover intention factor. Results: As a major turnover factor, it was found that the higher the level of organizational commitment and satisfaction with supervisors, and the lower the family obligation, the lower the turnover intention for production employees. As for sales/marketing employees, it was found that males had lower turnover intentions than females, and employees in mid/large sized companies or with higher satisfaction with their job itself and salary also had low turnover intention. For clinical/RA, employees in mid/large sized companies or with higher satisfaction with their job itself found to have lower turnover intention. Conclusion: In this study, the turnover factors for the three job fields have been analyzed in various conditions combined with job-related, organizational-related, and personal characteristics in the biopharmaceutical industry. It was found that there were significant differences in the turnover factors of each field. In particular, the turnover intention for production employees found to be lower when they have organization commitment or no family support obligation, or satisfy with their supervisor, whereas the turnover intention for sales/marketing and clinical/RA found to be lower when they work in mid/large size companies or when their job satisfactions are met. In addition, the intentions were also affected by gender or salary for sales/marketing employees. It is expected that the companies will identify the turnover factors and exact needs of employees derived in this study and use such findings to establish a plan to leverage job satisfaction in accordance with internal conditions and compensation policies of a corporation, thereby providing a foundation for stable growth of the company.

바이오제약 공정폐수처리에 있어서의 펜톤기법의 활용

윤성문 인하대학교 대학원 2013 국내석사

In this study, the Fenton reaction was studied for its possibility of application as advanced treatment and its optimal condition for the removal of refractory organics from the biopharmaceutical process wastewater. The wastewater originated from a plant producing a biopharmaceutical API. Treatability studies were conducted under laboratory conditions with wastewater, containing COD varying from 200 to 500 mg/L, which was produced in the plant in order to determine the optimal operational conditions to utilize in the full-scale treatment plant. Optimum dose ratio of COD/H2O2 and Fe2+/H2O2 was 0.4 and 0.6 respectively, providing 40–45% COD removal. With the full-scale plant operating continuously, the daily effluent was 240m3 and application of Fenton process with the optimal dosage ratio of COD/H2O2 and Fe2+/H2O2 showed an average of 40% COD removal and up to 50% and the following aerobic reaction had an average of 37% COD removal efficiency. Further, there was a significant improvement in accumulated COD removal at post aerobic reaction by 40%(from 37% to 77%) to show steady and fairly good treatment of COD where COD removal rate was 86% in overall treatment process and treated water showed below 80mg/L. Application of Fenton process improved the biodegradability and reduced the COD of the biopharmaceutical wastewaters and Fenton oxidation was an effective pretreatment method for the non-biodegradable portions of the wastewater, which renders them more biodegradable for successive biological processes.