웨비나
규제 준수와 공정 신뢰성을 확보하는 PUPSIT 실무 전략을 확인하세요.
EU 및 PIC/S GMP Annex 1 개정으로, 사용 전·멸균 후 무결성 시험(PUPSIT)은 오염 제어 전략(CCS)의 핵심 요소로 자리 잡았습니다.
특히 한국에서도 PIC/S GMP Annex 1 적용이 임박하면서, PUPSIT 도입은 더 이상 미룰 수 없는 과제가 되고 있습니다. 하지만 실제 공정에 PUPSIT를 적용하는 과정은 쉽지 않습니다. 다양한 제품 특성과 조건을 고려한 리스크 기반 접근, 그리고 최적화된 시스템 설계가 필요합니다.
본 웨비나에서는 Annex 1의 요구사항을 충족하면서도 효율적이고 실용적인 PUPSIT 구현 전략을 제시합니다. 최신 기술 트렌드와 실제 사례를 통해, 규제 준수와 생산성 향상을 동시에 달성하는 방법을 확인해 보세요.
본 웨비나에서는 아래와 같은 내용을 확인하실 수 있습니다.
2025년 11월 11일 (화) 오후 3시
온라인 (시청 링크는 등록하신 이메일 주소로 발송 드립니다)
Subtitle
웨비나 참여 이벤트
※ 고용 계약, 법률, 정부 규정 또는 그 밖의 적용 가능한 전문가로서의 행동 강령에 따라 Cytiva에서 제공하는 적당한 금액의 선물 또는 식사를 제공 받는 것이 금지되어 있을 경우, 설문조사에 참여는 가능하지만 선물 수령은 불가능합니다.
19 - 22 September, 2024
Kistamässan Exhibition & Congress Centre Kista, Sweden
웨비나 참여 이벤트
※ 고용 계약, 법률, 정부 규정 또는 그 밖의 적용 가능한 전문가로서의 행동 강령에 따라 Cytiva에서 제공하는 적당한 금액의 선물 또는 식사를 제공 받는 것이 금지되어 있을 경우, 설문조사에 참여는 가능하지만 선물 수령은 불가능합니다.
Subtitle
With Cytiva™ Protein Select™ resin and tag
12 September, 2024
The ELEVECTA™ cell line portfolio combines innovative design and deep expertise to deliver transient, packaging, and producer options that provide competitive performance, high quality, and flexibility.
Next generation in depth filter module technology for bioprocess clarification applications.
The SUPRAdisc™ II module design combines the filtration performance of Seitz™ media and the structural robustness of interlocking dual drainage plates.
9 - 22 September, 2024
Kistamässan Exhibition & Congress Centre Kista, Sweden
박정배, Resin Sales Specialist, Cytiva
항체 정제 공정은 생산성, 내구성, 그리고 품질의 균형을 요구합니다. Cytiva의 최신 Protein A 레진인 MabSelect PrismA X, SuRe 70은 이러한 요구를 충족시키기 위해 개발되었으며, 각각 높은 결합 용량과 내구성을 통해 차세대 공정 플랫폼에 최적화된 솔루션을 제공합니다. 또한, Mild elution 레진을 이용하여 낮은 pH 조건으로 인한 단백질 변성 및 응집 문제를 완화하는 솔루션을 소개할 예정입니다.
손지혜, AKTA & Imager Sales Specialist, Cytiva
바이오의약품 공정개발 및 생산과정에서 불순물 관리는 제품 품질과 안전성을 확보하기 위한 핵심 요소입니다.
연구, 공정 및 제조 단계 전반에서 불순물을 제거하고 정량화 하는 것은 제품의 품질과 안전성에 큰 영향을 미치는 필수적인 단계로 높은 품질 기준 유지를 위해 이러한 불순물의 수준은 매우 정확하고 신뢰할 수 있는 분석 방법을 통해 지속적으로 모니터링 및 관리되어야 합니다.
본 웨비나에서는 레진에서 유출되는 protein A 리간드 (Leached affinity ligand) 규제 동향과 Cytiva의 MabSelect PrismA레진, 최근 출시된MabSelect PrismA X 레진에 대응하는 최신 솔루션을 중심으로 바이오 제조 공정의 불순물 관리 전략을 소개합니다.
웨비나 참여 이벤트
※ 고용 계약, 법률, 정부 규정 또는 그 밖의 적용 가능한 전문가로서의 행동 강령에 따라 Cytiva에서 제공하는 적당한 금액의 선물 또는 식사를 제공 받는 것이 금지되어 있을 경우, 설문조사에 참여는 가능하지만 선물 수령은 불가능합니다.
Compact liquid chromatography system to support routine protein purification in research laboratories.
The ELEVECTA™ cell line portfolio combines innovative design and deep expertise to deliver transient, packaging, and producer options that provide competitive performance, high quality, and flexibility.
ÄKTA go™ protein purification system
| Throughput | Up to 300 units per load / 1200 units per 8-hour shift |
| Pump type | Peristaltic pump |
| Fill Volume Range | 1.0 – 50 mL |
| In-process control | Programmable up to 100% of units |
| Product contact materials | Single-use flow path assembly |
| Interior classification | ISO 5 / Grade A |
| Cleanroom classification | ISO 8 / Grade D |
| Dimensions | 1.7 x 1.5 x 2.2 m (5’6” x 4’9” x 7’2”) |
| Required cleanroom space | 15m² (160 sq. ft.) |
| Electrical | 208–240 VAC, single phase, 50–60 Hz, FLA 36 |
강연 제목: Annex 1 개정 대응 전략과 PUPSIT 실무 적용
시간: 약 30분
내용: 2022년 8월 개정된 EU GMP Annex 1은 무균 의약품 제조 공정 전반에 걸쳐 오염 제어 전략(CCS)과 멸균 직후 사용 전 무결성 시험(PUPSIT)의 중요성을 강조하고 있습니다. 한국 식약처 역시 해당 개정 사항을 반영해, 2026년 12월부터 PUPSIT 적용을 의무화할 예정이며 이에 따라 국내 제약업계는 실질적인 대응 전략이 필요한 시점입니다. Cytiva는 무균 충전 공정의 품질 보증을 위한 PUPSIT 솔루션을 다양하게 제공하고 있습니다. 본 웨비나에서는 Annex 1 개정의 주요 내용과 GMP에서 PUPSIT 적용을 위한 필터 선택, 시스템 구성 등을 소개할 예정입니다.
발표자: 이유미, Scientist I, Scientific and Laboratory Services, Cytiva
강연 제목: PUPSIT 공정 혁신: 자동화된 의약품 여과 시스템 소개
시간: 약 15분
내용: 싸이티바의 PUPSIT(PUPSIT: Pre-Use Post-Sterilization Integrity Test) 시스템은 멸균 후 필터의 무결성을 제품 여과 전에 검증하는 방식으로, 유럽 GMP Annex 1 및 한국 식약처 규정에 따라 무균 의약품 생산 시 필수적으로 요구됩니다.
싸이티바는 고객의 다양한 니즈에 맞춰 Manual, Semi-Automated, Fully Automated 옵션을 제공하며, 특히 Automated PUPSIT 시스템은 설치 오류 방지(HMI 가이드, Shadow board), 전자 배치 기록, 제품 회수 기능, 21 CFR Part 11 호환 등으로 고객의 운영 효율성과 규제 대응력을 극대화합니다. 단일 또는 이중 필터링 구성도 가능하며, 설치는 1인 기준 약 30분 내 완료됩니다. 또한, 오퍼레이터 실수를 줄이며, 데이터 기반 품질 관리가 가능해 제약사 및 CDMO 회사에 적합합니다. 식약처 유예기간 종료가 임박한 상황에서, 성공적인 PUPSIT을 위한 Automated Drug Product Filtration System을 소개할 예정입니다.
발표자: 원동빈, Bioprocess Downstream Field Application Specialist, Cytiva
Morbi faucibus sit amet dolor sit amet cursus. Quisque vulputate tellus in magna eleifend, ut luctus orci commodo.
Praesent tellus neque, maximus sit amet mauris in, fermentum pharetra ante. Sed sit amet nibh commodo, fringilla lectus ac, dictum velit. Aliquam cursus feugiat congue. Aenean sit amet enim massa. Praesent mollis sagittis est, ut accumsan eros lobortis id. Maecenas at libero ex. Proin quis est vitae tortor ullamcorper pretium eu non nunc. Quisque at lacus accumsan, finibus sapien ac, viverra ligula. Donec commodo bibendum elit sit amet posuere.
Praesent lacus arcu, mollis ut volutpat pharetra, vulputate quis massa. Nam interdum fringilla bibendum.
Sed feugiat libero eu turpis tincidunt iaculis. In vel aliquam est, at porta neque. Donec hendrerit ultrices consectetur. Integer feugiat massa quis arcu ullamcorper, tristique facilisis massa feugiat. Phasellus risus mauris, pretium vitae tortor non, tristique fringilla tortor. Aliquam volutpat eros ac risus consectetur, quis gravida erat lobortis. Quisque id rutrum enim, sed fermentum nisl. Nulla volutpat turpis ac ligula venenatis maximus. In non dui ante.
Morbi faucibus sit amet dolor sit amet cursus. Quisque vulputate tellus in magna eleifend, ut luctus orci commodo.
Praesent tellus neque, maximus sit amet mauris in, fermentum pharetra ante. Sed sit amet nibh commodo, fringilla lectus ac, dictum velit. Aliquam cursus feugiat congue. Aenean sit amet enim massa. Praesent mollis sagittis est, ut accumsan eros lobortis id. Maecenas at libero ex. Proin quis est vitae tortor ullamcorper pretium eu non nunc. Quisque at lacus accumsan, finibus sapien ac, viverra ligula. Donec commodo bibendum elit sit amet posuere. Curabitur rutrum.
Praesent lacus arcu, mollis ut volutpat pharetra, vulputate quis massa. Nam interdum fringilla bibendum. Maecenas non odio dui. Suspendisse eros ex, ullamcorper et dui non.
Sed feugiat libero eu turpis tincidunt iaculis. In vel aliquam est, at porta neque. Donec hendrerit ultrices consectetur. Integer feugiat massa quis arcu ullamcorper, tristique facilisis massa feugiat. Phasellus risus mauris, pretium vitae tortor non, tristique fringilla tortor. Aliquam volutpat eros ac risus consectetur, quis gravida erat lobortis. Quisque id rutrum enim, sed fermentum nisl. Nulla volutpat turpis ac ligula venenatis maximus. In non dui ante. Sed ullamcorper quis nisi.
Morbi faucibus sit amet dolor sit amet cursus. Quisque vulputate tellus in magna eleifend, ut luctus orci commodo.
Praesent tellus neque, maximus sit amet mauris in, fermentum pharetra ante. Sed sit amet nibh commodo, fringilla lectus ac, dictum velit. Aliquam cursus feugiat congue. Aenean sit amet enim massa. Praesent mollis sagittis est, ut accumsan eros lobortis id. Maecenas at libero ex. Proin quis est vitae tortor ullamcorper pretium eu non nunc. Quisque at lacus accumsan, finibus sapien ac, viverra ligula. Donec commodo bibendum elit sit amet posuere. Curabitur rutrum pharetra nisl, vitae tincidunt ante consectetur et.
ELEVECTA™ transient cell line
Preseves flexibility while delivering excellent performance and quality - all aimed at quickly advancing candidates to clinical trials.
ELEVECTA™ packaging cell line
Contains all genes except the transgene; allows streamlining the screaning of assets that use the same capsid to target the same tissue type.
ELEVECTA™ producer cell line
Contains all genes to produce AAV; simply induce. The result is a simplified, robust, upstream process that easily scales to treat hundreds of thousands.
A standard grade filter used in qualitative analytical techniques to determine and identify materials. For use in büchner funnels.
A standard grade clarifying filter excellent for cloudy suspensions and for water and soil analysis.
A general qualitative filter with creped surface. High filtration speed, faster than grade 202 and retain coarse particles gelatinous precipitates.
A standard grade clarifying filter excellent for cloudy suspensions and for water and soil analysis.
A standard grade filter used in qualitative analytical techniques to determine and identify materials. For use in büchner funnels.
Description
ÄKTA go™Achieve desired purity with ease in routine purifications – make the most of valuable bench/cold-room space |
ÄKTA pure™Flexibility in research – match most current and future purification challenges |
ÄKTA start™Entry level chromatography solution for the preparative purification of proteins in lab scale. |
ÄKTA oligosynt™Compact, fully automated oligonucleotide synthesizer to support research and process development laboratories. |
|
|---|---|---|---|---|
| Support for affinity chromatography, ion exchange chromatography, and multimodal (mixed mode) chromatography | yes | yes | yes | yes |
| Support for affinity chromatography, ion exchange chromatography, multimodal (mixed mode) and size exclusion chromatography | yes | yes | no | no |
| Support for hydrophobic interaction chromatography | yes | yes | yes | no |
| Scale up, method development and optimisation using design of experiment (DoE) | no | yes | yes | yes |
| Automated: resin/column scouting, multistep purification, external equipment | no | yes | no | yes |
| Wavelength (nm) | Fixed at 280nm | Optional Fixed at 280, dual 260/280 or multi – up to 3 between 190-700 | Fixed at 280nm | Optional Fixed at 280, dual 260/280 or multi – up to 3 between 190-700 |
| Recommended flow rate (mL/min) | 0.01-25.0 | 0.001-25/0.01-150 | 0.01-25.0 | 0.001-25/0.01-150 |
| Maximum operating pressure (Mpa) | 5 | 20/5 | 7 | 20/4 |
Beyond supporting your gene therapy processes with our technology and application knowledge, we're passionate about advancing solutions in areas where the status quo isn’t good enough. That's why we're excited to tell you about our ELEVECTA™ cell lines ― a significant advancement in viral vector manufacturing.
From posters and webinars to application notes and online learning, simply click on the links below to access some of our latest resources to support your cell and gene therapy advances.
Scientist I, Scientific and Laboratory Services, Cytiva
Bioprocess Downstream Field Application Specialist, Cytiva
Bioprocess Downstream Hardware Sales Specialist
Associate Scientist, Product Develipment, Cytiva
Chief Technology Officer, Danaher
Associate Scientist, Product Development, Cytiva
Senior Director of Innovation Advocacy, Cytiva
Associate Scientist, Product Develipment, Cytiva
Agenda and schedules are subject to change. All times listed are in CEST.
On the first day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.
| Time | Details | |
|---|---|---|
| 8:00 - 9:00 | Registration | |
| 9:10 - 10:40 | Nestor Santiago and Gillian Goodwin | Biacore™ system assay development revisited - Recipe for successful SPR data |
| 10:50 - 12:20 | Cynthia Shuman and Eric Roush | Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system |
| 12:30 - 14:30 | Lunch break | |
| 14:45 - 16:00 | Christin Radon and Emeric Gueneau | Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation |
| 16:10 - 16:40 | Anja Drescher and Mike Murphy | Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison |
| 16:50 - 17:20 | John Sinfield and Shannon Bryan | Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish |
On the second day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.
| Time | Details | |
|---|---|---|
| 7:00 - 8:30 | Registration | |
| 8:40 - 10:40 | Nestor Santiago and Gillian Goodwin | Biacore™ system assay development revisited - Recipe for successful SPR data |
| 10:50 - 12:20 | Cynthia Shuman and Eric Roush | Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system |
| 12:30 - 14:30 | Lunch break | |
| 14:45 - 16:00 | Christin Radon and Emeric Gueneau | Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation |
| 16:10 - 16:40 | Anja Drescher and Mike Murphy | Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison |
| 16:50 - 17:20 | John Sinfield and Shannon Bryan | Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish |
On the third day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.
| Time | Details | |
|---|---|---|
| 8:30 - 9:15 | Registration | |
| 9:25 - 10:40 | Nestor Santiago and Gillian Goodwin | Biacore™ system assay development revisited - Recipe for successful SPR data |
| 10:50 - 12:20 | Cynthia Shuman and Eric Roush | Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system |
| 12:30 - 14:30 | Lunch break | |
| 14:45 - 16:00 | Christin Radon and Emeric Gueneau | Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation |
| 16:10 - 16:40 | Anja Drescher and Mike Murphy | Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison |
| 16:50 - 17:20 | John Sinfield and Shannon Bryan | Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish |
Agenda and schedules are subject to change. All times listed are in CEST.
| Time | Details | |
|---|---|---|
| 8:30 - 9:00 | Welcome and opening | |
| 9:00 - 10:30 | Stephan Poetsch | ÄKTA™ chromatography systems family, system specifications and UNICORN with the new developments in the portfolio |
| 10:30 - 11:00 | Break | |
| 11:00 - 12:00 | Stephan Poetsch | ÄKTA™ basic care and troubleshooting - To prevent problems during protein purification |
| 12:00 - 13:30 | Christin Radon and Emeric Gueneau | Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation |
| 13:30 - 15:00 | Anja Drescher and Mike Murphy | Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison |
This free interactive course provides a high-level overview of preclinical study in cellular and gene therapy (CGT) development.
Attending DiPIA 2024 was incredibly inspiring! Connecting with global experts in SPR technology gave me new insights and ideas for my research.
Dr Mary Collins
University of Cambridge
DiPIA 2024 brought together leaders in protein interaction analysis. The sessions on SPR’s evolution were fascinating and opened up new possibilities for my work.
Dr John Davis
Institute for Biological Research
Attending DiPIA 2024 was incredibly inspiring! Connecting with global experts in SPR technology gave me new insights and ideas for my research.
Dr Anna Collins
University of Cambridge
DiPIA 2024 brought together leaders in protein interaction analysis. The sessions on SPR’s evolution were fascinating and opened up new possibilities for my work.
Dr Steven Davis
Institute for Biological Research
Attending DiPIA 2024 was incredibly inspiring! Connecting with global experts in SPR technology gave me new insights and ideas for my research.
Dr Mary Collins
University of Cambridge
DiPIA 2024 brought together leaders in protein interaction analysis. The sessions on SPR’s evolution were fascinating and opened up new possibilities for my work.
Dr John Davis
Institute for Biological Research
Bioprocess Downstream Hardware Sales Specialist
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
Associate Scientist, Product Develipment, Cytiva
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
Chief Technology Officer, Danaher
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
Associate Scientist, Product Development, Cytiva
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
Senior Director of Innovation Advocacy, Cytiva
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
Associate Scientist, Product Develipment, Cytiva
Vivamus hendrerit lectus sit amet rhoncus vestibulum. Quisque suscipit diam nec nunc vehicula mollis.
Nam blandit eleifend neque, id aliquam sem laoreet nec. Curabitur vitae maximus tellus. Ut pellentesque orci vitae nisi pharetra, non vestibulum nulla mattis. In hendrerit diam ut neque aliquam feugiat. Nulla rutrum sagittis nulla, vel tempor ipsum fermentum vitae. Curabitur venenatis semper lorem, ut pretium felis laoreet eget. In semper gravida tellus eu.
