This conference is focused on the use of single-use equipment in biopharma and sterile production. Meet us on our booth to discover our recent advances in Viral Vector manufacturing. Spend some time to ask our experts for advice and take advantage of this face-to-face experience. Looking forward to meeting you.
This page will be updated closer to the event start date. More information about our participation including new technologies, platforms, products and systems will be added in due course.
Pharmtech & Ingredients - the largest exhibition of equipment, raw materials and technologies for pharmaceuticals production in Russia and EEU countries.
Join us on our booth A3093 Hall7, take this opportunity to meet us and find solutions for your current projects!
Do not miss our presentation on Wednesday, November 20 from 2.20 p.m. to 4.20 p.m. in zone B:
Regulatory Compliance: Is Your Validated Process Up to Date? What About Evolving Regulatory Expectations?
The landscape for the manufacture of sterile medicinal products is evolving. Complex formulations are on the rise. These bring filterability challenges and bacterial retention challenges. Validation of clinical phases bring additional challenges in terms of GMP compliance and Regulatory expectations. With SUT adoption, polymeric components pose new challenges to end users. Join us for this two-hour interactive presentation to find out more.
- Evolving Landscape for the manufacture of Sterile Medicinal
- QRM and QbD
- Standardized Extractable Packages for Component Qualification
- Approach to Process specific evaluation of E&L
The involvement of microbiology experts and opinions leaders, regulatory body representatives, new technologies suppliers and consultants from Italy and Europe, made this event unique and higly evalued by Pharma, Biotech, Medical Devices companies and by the technologies suppliers, for the great opportunity to meet professionals and get and share technical knowledge and strategies about the future of Sterile Manufacturing.
Take the opportunity to meet us in the exhibition area and find solutions to your challenges in sterile manufacturing.
We will host two presentations during this event:
Thursday, November 14, 11.55 a.m. - 12.20 p.m.
Presentation: How to Safely and Reliably Implement Filter Pre-Use Post-Sterilization Integrity Testing (PUPSIT)
Antonio Pierno, Principal Engineer, Scientific Laboratory Services – Pall Biotech
Friday, November 15, 11.20 a.m. - 11.50 p.m.
Presentation: QRM Approach Applied to Define a SUS Integrity Control Strategy and Associated Control Technologies
Patrick Evrard, Sr. Principal Engineer, Single-use Technologies, Scientific Laboratory Services - Pall Biotech
Looking forward to meeting you!
Welcome to BioProduction, take the opportunity to engage 500+ decision makers seeking manufacturing technologies and services to accelerate their biologics and novel molecules towards commercial success!
Whatever your bioprocessing journey, we have the technologies, services and knowledge to support your chosen path and to help you arrive at your destination simply and quickly. Our depth of portfolio supports your entire process, whether your preference is for traditional manufacturing methods or to access the benefits of single-use. Beyond this, our unique set of Continuous Ready technologies empowers you to leverage the benefits that this brings, in whole, or as part of a hybrid solution so your process can develop and grow. Not certain of what direction you want to take? Let us share our insights and experiences on booth 120D32 Hall 12.0.
Tuesday, November 5 at 5 p.m.
Presentation: Continuous Bioprocessing –The Alignment of Future Strategies to Industry 4.0
Peter Levison, Executive Director Business Development, Pall Biotech
The toolbox of continuous bioprocessing technologies available today offers choices for each unit operation in an end-to-end process providing improved facility utilization, optimized productivity, improved product quality all leading to enhanced patient safety. As we move toward Industry 4.0 we see that automation, control and data management are key aspects of future new continuous bioprocesses. There will be an increased use of virtual reality to design facility layout and optimize equipment usability and digital twins will be used to evaluate various continuous production scenarios and create risk mitigation strategies.
Wednesday, November 6, 1.30 p.m. to 1.40 p.m.
LIVE LAB SESSION
Presentation: Cadence® BioSMB: Our Disposable Flow Path, Continuous Multi-Column Chromatography Solution
Marc Bisschops, Director SLS Continuous Bioprocessing, Pall Biotech
Since its introduction in 2010, continuous bioprocessing has been gaining significant momentum. The first clinical manufacturing campaigns have been successfully completed in 2019.
The key enabling technology for continuous downstream processing is multicolumn chromatography. The Cadence BioSMB technology by Pall Biotech is unique in its flexibility and its single-use flow path. This has made it one of the leading solutions in the field of continuous downstream processing.
During the live lab tour, we will present the Cadence BioSMB PD system that is used for process development and process characterization. We will discuss the system architecture and how this translates into manufacturing scale in the Cadence BioSMB Process system.
A Road Map to Licensure for Multicolumn Capture in a mAb Process
Application of multicolumn chromatography for affinity capture in process scale manufacturing of monoclonal antibodies has significant impact on cost savings from reduced sorbent and buffer requirements compared to conventional batch operation. A case study is presented investigating the Cadence® BioSMB system to support incorporation of multicolumn chromatography for capture into an existing commercial antibody drug platform. Here we take an approach that relies on modelling breakthrough curve data to derive process conditions that demonstrate multicolumn chromatography can achieve capture efficiency and product quality consistent with current process specifications. By leveraging mechanical stability of the sorbent, we demonstrate multicolumn chromatography can operate within time constraints for capture with only 7% of the sorbent volume currently required for processing. A risk based approach is then explored to identify aspects relevant to column performance, bioburden management and process integration. In this approach, data from both single column and multicolumn experiments help us to better characterize the space for operation and provide justification to satisfy requirements for regulatory submission.
Looking forward to meeting you!
The European Society of Gene and Cell Therapy organises its 27th annual congress in Barcelona. The congress brings together scientists working in the fields of gene and cell therapy from throughout Europe and beyond. It is a platform for highlighting the latest research and techniques through the scientific sessions, which include keynote lectures, invited speakers, selected speakers, poster sessions and exhibitions.
Come and meet the Pall Biotech team at booth 66 in theeExhibition area to discuss your projects.
Three scientific posters will be presented:
- Comparison of Static, Suspension and Fixed-Bed Bioreactors to Manufacture Commercial Gene Therapy Products
- Adherent HEK293T Cells Cultured in Pall’s iCELLis® Nano Bioreactor with OptiPEAK HEK293T Blood-Free Chemically Defined Media Exhibit Robust and Rapid Population Doubling Times
- Pall Xpansion® Bioreactor Supports Progenitor Cell Growth to >1 Million cells/cm2 and Proper Cell Differentiation
Meet with us at our booth and near our posters during the poster session.
Join us during this day of professional growth, discussion and updates on the main trend of Advanced Therapy Medicinal Products.
The agenda will cover:
- Advanced therapies, transplantation and clinical experimentation
- Spotlight on CAR-T cells
- Industry Advances in Advanced Therapies
- Regulatory aspects in Advanced Therapies
13:30 – 13:45
Presentation: "Accelerator Process Development Services: Your Journey to Industrialization Starts Here"
Marco Sanvito, Senior Regional Marketing Manager, Pall Biotech (Italy)
The journey to commercializing a therapeutic is a complex and challenging one. It is filled with tasks that include ensuring patient safety, building a product portfolio, working with regulatory agencies, achieving economies of scale on a process typically designed at the academic level, defining a product platform, and addressing fluctuating demands – all while keeping down costs. With the ever-shrinking pool of resources and technical expertise, these can be daunting tasks to achieve. At Pall, we understand the issues you are facing, and while we may not be able to solve all your journey’s challenges, what we can do is help to minimize the risk. We deliver a robust, reproducible and scalable process that helps you move beyond laboratory scale process choices to those that are proven to support industrialized processes. Using our global centers of excellence and our industry leading technology, we specialize in designing, optimizing and transferring scalable processes from pre-clinical to validated cGMP manufacturing.
Take some time to see us at presenter sessions throughout the event. We look forward to meeting you!
At the next A3P International Congress, the conferences will allow you to supervise the quality of your productions & controls from the "Contamination Control Strategy" to the visual inspection to be in a position of excellence during regulatory inspections.
As for the workshops on Wednesday, they will address specific topics in front of a participative audience by mixing theory and practice with among As for the workshops on Wednesday, they will address specific topics in front of a participative audience by mixing theory and practice with among others the utilities (water and gas), the cleanings, the new technologies (SUT) and the integrity of the data.
See you for this 31st congress, during which your participation will allow the technological advances of clean and sterile!
Come to our booth and find the Presto connectors hidden in the production facilities using virtual reality. We look forward to meeting you!
Cell Culture B4B-Connection is entirely dedicated to Cell Culture. This edition will focus on cell culture in R&D but also in bioproduction. All leading actors will join this event from small scale production, solutions provider, innovative materials suppliers, industrials, CMO, CDMO, CRO.
A broad field of topics will be discussed: cell storage, cell culture medium, cell lines, viral or non viral vectors, gene therapy, 2D and 3D cell culture, upstream processes, upscale, CAR-T, adherent or suspension cells, small volume / large volume, mixing, bioreactors, sensors for control, optical technologies, microscopes, cell therapy, cell engeneering, viral vector optimization, characterization, analytics and quality control.
The idea is to open discussion around technical challenges and solutions from three angles:
- Innovative Tools and Materials
- New perspectives and paradigm shifts
Come and meet our Pall experts to learn more about our Accelerator℠ Process Development Services. The team will give a presentation on October 8th, 2019 at 12:00 PM entitled 'Accelerator℠ Process Development Services: Bioprocesses Development and Manufacturing of Gene Therapy Products'.
The journey to commercializing a therapeutic molecule is a complex and challenging one - filled with obstacles that include building a product portfolio, ensuring patient safety, dealing with regulatory agencies, achieving economies of scale on a process typically designed at the academic level, defining a product platform, and addressing fluctuating demands - all while keeping down cost. With the ever-shrinking pool of resources and technical expertise, these can be daunting tasks to achieve.
Meet with us on our table top and during our talk!
Join us for an exciting interactive seminar.
As gene therapies move towards commercialization, a robust, scalable and affordable manufacturing process is critical to ensure these novel therapies reach the patient and that a pipeline of clinical assets can be rapidly developed.
This seminar will address the current manufacturing challenges faced by the industry and offer potential solutions. Choosing the right technologies capable of producing the required amount of virus at the right quality is more important than ever.
Pall’s automated, end-to-end integrated platform solution coupled with our Accelerator℠ Process Development Services offers a holistic approach designed to decease risk, costs and speed you to market for your viral vector manufacturing.
Reasons to join:
- Meet the experts
- Discover scalable single-use technologies
- Learn about our PDS capabilities
- Listen to end-user case studies
09:00 a.m. – 09:30 a.m.
Registration and coffee/tea
09:30 a.m. – 10.15 a.m.
Market Overview and Challenges for GT Commercialisation
Clive Glover, Pall Biotech
10:15 a.m. – 11:00 a.m.
Pall Integrated Solutions for Gene Therapy
Chris Feeney, Pall Biotech
11:00 a.m. – 11:30 a.m.
11:30 a.m. – 12:10 a.m.
Accelerator Process Development Services for Viral Vector Production
Byron Rees, Pall Biotech
12:10 a.m. – 12:55 p.m.
Case Study for Adeno-associated Virus
Yatindra Tirunagari, Freeline Therapeutics
12:55 p.m. - 14.00 p.m.
14:00 p.m. - 14.30 p.m.
Biopharmaceuticals has become a main pillar in the pharmaceutical industry, with significant transformation in the development, strategy, technology and operations. This transformation is a continuous process, which is impacted by other developments in digitalisation amongst other factors.
Entirely new concepts, such as gene - and cell therapy, are being brought to market, which offer even more possibilities to regenerative medicine or disease remission. However, there are still operational and technological challenges.
The 2019 ISPE Europe Biotechnology Conference will address these topics with industry case studies and plant tours. Most important, the conference will allow for collaborative dialogue with presenters, regulators, industry, peer groups and top managers in an interactive forum.
Take this opportunity to meet with us at tabletop #24 or during coffee break and find solutions to your on-going projects.