■日時: 2018年6月28日（木） 13:40 - 14:40
■演者: 長谷川 孝夫 - 日本ポール株式会社 バイオテック事業部 シニアバイオテックスペシャリスト
■講演タイトル: Pall Biotech：バイオ医薬品連続生産のためのソリューション
■アップストリーム・ポートフォリオ: アレグロ STRシングルユースバイオリアクターシステム、Xpansionマルチプレートバイオリアクターシステム、アレグロXRS 25 二軸撹拌バイオリアクターシステム、iCELLis nano and 500 固定床バイオリアクターシステム、mPath™ベンチトップバイオリアクターコントロールタワー
■バイオ医薬品製造の連続生産ポートフォリオ： 音波凝集細胞除去システムCadence™ Acoustic Separator、マルチカラム連続クロマトグラフィーシステムCadence™ BioSMB System、バッチ生産または連続生産用 Cadence™ Virus Inactivation System 、 シングルパスTFFタンパク質濃縮システムCadence™ In-line concentrator、シングルパスＴＦＦ ダイヤフィルトレーションシステム
Cadence™ In-line diafiltration systems
■バッチプロセス・ポートフォリオ： Stax™ カプセルフィルター、 アレグロ・シングルユースクロマトグラフィーシステム 、ペガサス・プライム ウイルス除去フィルター
Join us at the Pharmtech exhibition to discover our most recent advances in continuous bioprocessing. Visit us at booth #A429, Hall 7, for a week of expert knowledge, cutting-edge technology and critical learning, all delivered with news of the latest industry trends and breakthroughs in science and technology.
Pharmtech & Ingredients is the largest international exhibition in Russia and the CIS presenting equipment, raw materials and technologies for manufacturing pharmaceutical products, nutritional supplements, blood products and cosmetics. It gives companies – producers and suppliers – a unique opportunity to present modern production and packaging equipment, laboratory equipment, projects and technological solutions for turnkey pharmaceutical manufacturing, for cleanrooms and for clinical trials conduction.
The Ingredients sector is intended to reflect the increased role of high quality active pharmaceutical ingredients and functional ingredients for producing modern medicines.
Pall has turned continuous bioprocessing theory into reality. Only Pall has the Continuous Ready products and integration expertise that has made Continuous Bioprocessing a reality. They enable bioprocessors to achieve the highest product quality, productivity and patient benefit with a dramatically smaller footprint and shorter lead times.
Pall Life Sciences invites you to join industry leaders for two days of expert knowledge, cutting-edge technology and critical learning. All delivered with industry case studies, latest industry trends and breakthroughs in science and technology.
Tuesday, November 14th
12:00 pm - 1:30 pm
Registration and Networking Lunch
1:30 pm -1:40 pm
Welcome and Introduction
1:40 pm - 2:10 pm
‘An Update on Significant Technology Advances Enabling Integrated Continuous Bioprocessing’
2:10 pm - 3:55 pm
‘Making a Business Case for Integrated Process Technology’
3:55 pm -4:25 pm
Break – Posters
4:25 pm - 6:10 pm
Workshop: 3 Technology Sessions Running in Parallel (40 Minutes/Workshop)
6:10 pm - 6:20 pm
Summary and End of Day 1
Departure from DoubleTree Hotel
Return to DoubleTree Hotel
Wednesday, November 15th
8:15 am - 8:30 am
8:30 am - 10:15 am
‘Experiences About Processing and Technology Challenges From Batch to Continuous’
10:15 am - 10:45 am
Break – Posters
10:45 am - 2:30 pm
Roundtable - Applying ICH Q8/Q9 to Continuous Processing
12:30 pm - 13:00 pm
Drivers for an Evaluation of Continuous Capture Chromatography at KBI Biopharma
13:00 pm - 13:05 pm
Event Summary and Closing
13:05 pm - 14:30 pm
Join us at this event to discover our total mixing solutions at this Swiss Cleanroom Community Event, the meeting place of the GMP and cleanroom sectors, held twice a year for knowledge transfer, product information and networking. The education and networking in this stimulating atmosphere are the success of the event.
We will take this opportunity to present you our total mixing solutions - a critical operation within many biopharmaceutical processes for applications ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation to final formulation.
Pall provides the broadest range of single-use mixers, covering all potential applications and requirements. Our magnetic drive technologies (Magnetic and LevMixer® units) represent the foundation of the largest installed base of mixing technology globally.
With our automation expertise and complementary technologies such as the Pall powder transfer bags and the Allegro™ MVP system, we can provide full automation around mixing applications with our standard systems, or customized solutions.
We look forward to meeting you!
Join us during this day of professional growth, discussion and update on the main trend of Advanced Therapy Medicinal Products.
- Developing T-cell therapy program
- “Hospital Exemption”
- Neural stem cells in MS: from bench to bedside
- CAR-T industrialization
- Clinical applications of MSCs in HSCT and beyond
- Latest advances for CARCIK.CD19 clinical protocol
- Bioreactors for viral vectors manufacturing
- Regulatory perspective
13:00 – 14:00
Presentation: Lentiviral/Retroviral Vector Manufacturing Production using iCELLis® Disposable Fixed-Bed Bioreactor iCELLis System"
Manuela Cota, Upstream Vector Development Supervisor, MolMed S.p.a. (Italy)
Lentiviral vectors (LVV), produced with transient quadri-transfection in 293T adhesion cell line and retroviral vectors (RVV), produced with a stable packaging cell line, are used in gene therapy studies. In the context of advanced clinical studies or commercial phase, an important manufacturing challenge is the optimization of vector production in large-scale platforms. To address this issue and to obtain a scalable and robust process, development studies were performed using iCELLis fixed-bed disposable bioreactors.
The optimized parameters included seeding cell density, DNA concentration, transfection agents, timing and volumes of harvest. Final vectors were characterized for infectious viral titer (TU/mL), particle content (ng p24 or ng p30), process related impurities and then compared to vectors produced by current GMP processes based on Cell Factories (CFs).
Productivity was 5.7 x 106 TU/mL with an infectivity of 6 x 104 TU/ng p30 and 3.1 x 107 TU/mL with an infectivity of 8 x 104 TU/ng p24 for RVV and LVV, respectively. Productivity using bioreactors was higher than that obtained in GMP CFs based processes while impurities profiles (BSA, HCD, HCP) were overall comparable. Vectors manufactured in bioreactor were used to transduce primary cells (CD34+ and T cells) showing high transduction efficiency and vector copy number. Although the downstream process currently in use for GMP LVV production can be successfully applied to vectors produced in small scale bioreactors, a different strategy is under development to accommodate larger volumes. Preliminary data indicate the possibility to efficiently purify vectors with no detrimental impact on process performance, vector infectivity and stability.
The ESGCT Annual Meeting provides an opportunity for scientists, clinicians and industry professionals to share new data, learn from peers, and discover global advances within the Gene and Cell Therapy field.
Pall's cell therapy technologies and services include powerful manufacturing platforms designed to help you overcome the challenges associated with producing live cells destined for therapeutics, and streamline your pathway to commercialization in these very exciting applications.
Our business philosophy and culture are centered on helping our customers achieve their goals. Together, our combined expertise is advancing the development of cell therapies that will improve the lives of patients worldwide.
Mercoledì 7 Giugno dalle 9 alle 12 partecipa al nostro workshop “Verso una produzione in continuo, basata su unità integrate e modulari.”
Lo sviluppo di specifiche tecnologie produttive, Continuous Ready Technology, unitamente agli intrinsechi benefici derivanti dalle tecnologie monouso, Single Use Technology, rendono possibile la transizione da produzioni batch a processi in continuo. La prossima frontiera per l’Industria Farmaceutica è rappresentata dall’adozione del processo in continuo su larga scala. Ciò rappresenterà l’ideale punto di arrivo di un rinnovamento che passa attraverso delle tappe intermedie: Single Use Facility - Process Intensification - Integrated Unit Operation - Continuous Process.
- Cadence™ Acoustic Separator
- Kleenpak® Presto Sterile Connector
- Allegro Single-Use Filing Needles
- Pyrofree♦ Vials
Richiedi un incontro con i nostri Specialisti e scoprire la nostra gamma di tecnologie Continuous Ready!
Over the past decade, biomanufacturing has become a strategic driver to scalable and flexible operations, controlled costs. The advances in manufacturing technologies–in particular continuous manufacturing, process analytical technology, single-use systems, alternative downprocessing techniques lead to improve the efficiency of the processes contributing to cost reduction which becomes a challenge for all the drug makers.
In the upcoming Biomanufacturing A3P Congress, you will have the opportunity to learn about key trends, methodologies and insights on manufacturing, process development, quality management and compliance of bioproducts.
Pall® Products Featured
Cadence™ Acoustic Separator, Kleenpak® Presto Sterile Connector, Allegro Single-Use Filing Needles, Pyrofree♦ Vials
Just some of the reasons to see us at booth #B6 or at presenter sessions and forums throughout the event. We look forward to meeting you!
Join us at the Virus and TSE Safety Forum for three days of expert knowledge, cutting-edge technology and critical learning, all delivered with news of the latest industry trends and breakthroughs in science and technology.
Spend some time to ask our technical experts for advice on a range of process-related subjects, and engage with our presenters following a series of technology and market overview presentations which will take place on day two. During the event, Pall scientists will be presenting a series based on all-new technical data in the Poster and Exhibit Hall, so make sure to take some time to meet with them and discuss the results. You'll also get the chance to see a range of ground-breaking, class-leading new technologies and products.
Pall® Products Featured:
Kleenpak® Presto Sterile Connectors, Pegasus™ Prime Virus Removal Filters, Allegro™ Single-Use Filling Needles, Pyrofree♦ Vials
Just some of the reasons to see us at booth #16 or at presenter sessions and forums throughout the event. We look forward to meeting you!
Join us at the ESACT Meeting on May 15-17 at booth #1 to discover recent advances in Cell Culture Technologies.
Spend some time to ask our experts for advice on a range of process-related subjects. You'll also get the chance to see a range of ground-breaking, class-leading new technologies and products.
Did you know that our 1000 L Allegro™ STR1000 Single-Use Stirred-Tank Bioreactor can be easily installed in minutes? We will demonstrate this live on our booth!
- Monday May 15: 10.30-11.00 and 17.00-17.30
- Tuesday May 16: 10.30-11.00
- Wednesday May 17: 10.30-11.00
Poster Sessions in Exhibition Hall
We will be presenting a series based on all-new technical data in the Poster Sessions in Exhibition Hall, so make sure to take some time to meet with us and discuss the results.
Monday May 15 from 14.00 to 15.30
- Cost Modelling of Upstream Production Process of Lentiviral Vectors in HEK-293 Cells Comparing Multi-Tray 10 Stacks and Fixed-Bed Bioreactor - PO131
Presenter: Pascal Lefebvre – Global Product Manager, Pall Life Sciences - Belgium
- Acoustic Wave Separation – A Scalable Disruptive Technology for Continuous Clarification of Fed Batch Cell Culture Prior to Capture Chromatography - PO069
Presenter: Britta Badertscher – Technical Specialist, Pall Life Sciences - Switzerland
- A High-Throughput Cell Proliferation Assay For Screening Single-Use Materials For Cell Culture Compatibility - PO367
Presenter: Todd Sanderson – Senior Scientist, Pall Life Sciences - USA
Tuesday May 16 from 14.00 to 15.30
- Development of a Scalable Viral Vector Upstream Process for Gene Therapy: rAAV-8 Production by Transient Transfection of HEK-293 Cells in iCELLis® Bioreactor - PO350
Presenter: Pascal Lefebvre – Global Product Manager, Pall Life Sciences - Belgium
- Scalable Stem Cell Expansion Bioprocess using Single-Use, Fed-Batch Reactor Engineered for High Productivity - PO126
Presenter: Dave Splan - Principal Research Scientist, Pall Life Sciences - USA
- Engineering Characterization of the Allegro Stirred Tank Reactors for Successful Cell Culture Scale-Up - PO106
Presenter: Joe Capone - Global Product Manager, Pall Life Sciences - USA
Do not miss this opportunity to meet us!
Pall® Products Featured
- Allegro STR1000 Single-Use Bioreactor
- iCELLis 500 Fixed-Bed Bioreactor and iCELLis nano Bioreactor
- Xpansion® 200 Multiplate Bioreactor System
- SoloHill® Microcarriers
- Allegro Unison hMSCs and Media
- Allegro™ Microcarrier Delivery System (AMDS)
Just some of the reasons to see us at booth #1 or at poster sessions throughout the event. We look forward to meeting you!