Main Conference - Day 1 - GMT (Greenwich Mean Time, GMTZ)
Main Conference - Day 1 - GMT (Greenwich Mean Time, GMTZ)
- Ketki Vispute - Associate Director, CAR-T Manufacturing, Autolus
- Elin Forsberg - Senior Scientist, Cell Therapy, Cardiovascular, Renal and Metabolism (CVRM), Biopharmaceuticals R&D, AstraZeneca
Wyatt Technology is the leading provider of advanced tools for the characterisation of macromolecules and nanoparticles in solution, measuring absolute molar mass, size, charge and interactions. Our technology includes the finest instruments and software available for: chromatographic and composition-gradient multi-angle static light scattering, high-throughput dynamic light scattering, field flow fractionation, differential refractometry, electrophoretic mobility and differential viscometry.
This presentation shows the application of MALS and DLS to characterise AAVs, LNPs, liposomes and other delivery systems and the information that can be obtained using real life examples. This is then extended with the introduction of a novel separation technique, FFF, ideally suited to larger and more complex viral vectors and then finishing with a review of MALS techniques applied to add real time process feedback in lab, pilot and production environments.
- Phil Cresswell - Account Manager – Ireland, Waters Wyatt Technology
- Janneke Meulenberg - Managing Director, MeiraGTx Netherlands B.V.
- Markus Haindl - Global Head Gene Therapy Technical Development, Roche Diagnostics, Germany
- Nasser Sadr - Senior Director Global Analytical Development, uniQure
The successes of genomic medicines such as gene therapies and RNA-based vaccines continue to multiply. As these types of medicine become more important, so do systems to make them safely and consistently. In this talk we’ll review the current state of manufacturing in this area with a focus on viral vectors. And we’ll highlight key innovations that will enable a new era in viral vector manufacturing.
- Emmanuelle Cameau - Strategic Technology Partnership Leader, Cytiva
- Marina Tarunina - Research Director, Plasticell Ltd
As the curative potential of gene therapies are unlocked, the need to find innovative manufacturing solutions for the production of viral vectors becomes critical to meet patient needs, ensuring the cost effective delivery of life saving drugs in the right place at the right time. FUJIFILM Diosynth Biotechnologies’ approach to innovation to bring new manufacturing solutions to the market, allied to a deep understanding of customer needs, and the requirements of taking products through clinical phases to commercialisation, will help overcome some of the current challenges of manufacturing ATMPS. This talk will discuss how innovation at FUJIFILM Diosynth Biotechnologies is being used to alleviate obstacles currently facing ATMP manufacturing from pre-clinical to commercial and beyond.
- Matthew Vaughan - Technical Project Leader, FUJIFILM Diosynth Biotechnologies
- Nripen Singh, Ph.D. - Head of Process and Product Development, Passage Bio
As the curative potential of gene therapies are unlocked, the need to find innovative manufacturing solutions for the production of viral vectors becomes critical to meet patient needs, ensuring the cost effective delivery of life saving drugs in the right place at the right time. FUJIFILM Diosynth Biotechnologies’ approach to innovation to bring new manufacturing solutions to the market, allied to a deep understanding of customer needs, and the requirements of taking products through clinical phases to commercialisation, will help overcome some of the current challenges of manufacturing ATMPS. This talk will discuss how innovation at FUJIFILM Diosynth Biotechnologies is being used to alleviate obstacles currently facing ATMP manufacturing from pre-clinical to commercial and beyond.
- Matthew Vaughan - Technical Project Leader, FUJIFILM Diosynth Biotechnologies
- Carlotta Peticone - Principal Scientist, Cell Process Development, Orchard Therapeutics
- Jorge Costa - Life Sciences Industry Consultant, Emerson Automation Solutions
There is significant need to improve existing AAV manufacturing platforms to achieve robust, high-yielding, scalable and cost-efficient processes. At Ultragenyx we employ a producer cell/helper-virus based infection process for AAV production which has been demonstrated to be scalable from bench to 2000L scale with high yield up to 1E12 GC/mL and effectively eliminate the high cost of goods associated with the traditional AAV platforms. This presentation will review the most recent progresses on our platform and give case studies on how we solved program- or clone- specific challenges on cell growth, product quality and productivity.
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
The manufacturing of biologics has been shifting from traditional stainless steel to Single-Use-Systems (SUS) which offer advantages such as flexible processes and small-scale production. However, as SUS are made from polymeric materials, they introduce new risks such as higher extractables and leachable content during fluid handling. Some of these impurities are a result of physical processes like peristaltic pumping, while others are introduced through dissolution of the polymeric material in the process solvent. In this talk, we will consider the selection of materials in fluid transfer tubing and their effect on the amount of extractables and leachables produced, ultimately improving the yield and purity of the final biologics particularly in the cell and gene therapy space.
- Rowanne Lyons - Scientist, DuPont de Nemours
- Eric Halioua - President & Chief Executive Officer, PDC*line Pharma
- George Frodsham - CEO, MediSieve Limited