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

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      https://www.riss.kr/link?id=T16662828

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      다국어 초록 (Multilingual Abstract)

      영어
      한국어
      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.
      번역하기

      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...

      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.

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      국문 초록 (Abstract)

      한국어
      영어
      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.
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      바이오 의약품은 인체에 부작용이 적고, 효과는 우수한 신약이며, 기존의 합성 의약품이 가지고 있는 물리, 화학적인 한계를 넘어서고 있다. 한국은 바이오 의약품의 중심지로 성장하고 있...

      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.

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      목차 (Table of Contents)

      • Part Ⅰ. Preparation and characterization of polyethersulfone microfiltration membranes 1
      • Ⅰ. Introduction 2
      • 1. Biotechnology in stocks market in Korea 2
      • 2. Bio manufacturing and processing 3
      • 3. Background of the study 4
      • Part Ⅰ. Preparation and characterization of polyethersulfone microfiltration membranes 1
      • Ⅰ. Introduction 2
      • 1. Biotechnology in stocks market in Korea 2
      • 2. Bio manufacturing and processing 3
      • 3. Background of the study 4
      • 4. The role of membranes in bioprocess 6
      • 5. Virus clearance via membranes 8
      • 6. Effect of Materials of membrane 11
      • 7. Tangential-flow filtrations (TFF) in bioprocess 12
      • 8. Disposable membrane filtration on single-use process 17
      • 9. Perfusion membrane filtration 20
      • 10. Commercial membrane manufacturer 25
      • Ⅱ. Theory 27
      • 1. Membrane fabrication and separation 27
      • 2. Microfiltration Membrane 39
      • 3. Membrane fouling and concentration polarization 45
      • Ⅲ. Experimental 51
      • 1. PES microfiltration membrane with sulfonated PES 51
      • 2. Membrane Fabrication process as pilot scale 53
      • 3. PES Membrane Characteristics 53
      • Ⅳ. Result and Discussion 57
      • 1. Polymerization of Sulfonated PES 57
      • 2. Lab scale PES membrane fabrication 59
      • 3. Pilot scale PES membrane fabrication 71
      • 4. Bottle top filter Assembly 74
      • Ⅴ. Conclusion 79
      • Part Ⅱ. Preparation and characterization of lateral flow nitrocellulose membrane 81
      • Ⅰ. Introduction 82
      • 1. COVID-19 and In Vitro Diagnostic antigen test 82
      • Ⅱ. Experimental 95
      • 1. NC membrane fabrication 95
      • 2. NC Membrane Characteristics 95
      • Ⅲ. Result and Discussion 99
      • 1. Pilot scale NC membrane fabrication 99
      • Ⅳ. Conclusion 143
      • Part Ⅲ. Comprehensive Conclusion 145
      • Reference 149
      • 국문초록 228
      더보기

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