The venue for this event will be
The Stevenage Bioscience Catalyst, within the GSK complex, Stevenage, UK
The Stevenage Bioscience Catalyst campus is a unique bioscience community created to provide small biotech and life sciences companies and start-ups with access to the expertise, networks and scientific facilities traditionally associated with multinational pharmaceutical companies.
The increased titres and productivity of the latest generation of cell lines are now well documented and understood. The rate limiting steps and capacity constraints within biopharmaceutical production have now moved to the downstream arena. This meeting combines both users and suppliers to provide an insight into how these constraints are being addressed by the industry as a whole.
This event has CPD accreditation and will have a discussion panel session.
On registration you will be able to submit your questions to the panel that will be asked by the chair on the day of the event
Meeting Chair: John Moys, ThermoFisher Hyclone, UK
9:00 – 9:45 Registration
9:45 – 10:00 Introduction by the Chair: John Moys, ThermoFisher Hyclone,, UK
10:00 – 10:30 Buffer evaluation - a critical step in process development
Dr Craig Hart, Cobra Biologics UK
Craig will discuss the importance of considering the buffers and their stability early in the mAb development process. The in-process formulations and hold step buffers should not only be stable at room temperature, but should be able to withstand freezing, should the need arise as the move is made into large scale production
10:30 – 11:00 Use of disposable technologies in the development of microbial biologics processes
Dr. Steve Loftus, FUJIFILM Diosynth Biotechnologies UK Ltd,¸UK
11:00 – 11:30 Speakers’ photo then mid-morning break/networking and trade show
Please try to visit all the exhibition stands during your day at this event. Not only do our sponsors enable Euroscicon to keep the registration fees competitive, but they are also here specifically to talk to you
11:30 – 12:00 Biosimilar Process Development Challenges
Dr Stuart Melvilles, Eden Biosciences, UK
As more blockbuster drugs reach patent expiry, an ever increasing number of biologics companies are developing biosimilars. The complex high molecular weight structures of biopharmaceuticals, their inherent heterogeneity and dependence on production in living systems gives rise to a number of difficulties during development. In this presentation Stuart will discuss the global challenges that face the industry encompassing upstream, downstream and analytical development challenges.
12:00 – 12:30 Single Pass Tangential Flow Filtration a New Technology for Overcoming Production Bottlenecks
Aloke Dey-Chowdhury, Pall Life Sciences¸UK
12:30- 13:00 A new paradigm for large scale mAbs downstream processes
Dr Fabien Rousset, Novasep, France
The need for new technologies that strongly reduce the process time and general equipment costs (included in the COGs) is more and more urgent. Novasep present a new paradigm that envisions possible future downstream processes. The capture step in the downstream processing of antibodies is the bottleneck and the most expensive process step due to the use of costly protein A affinity media.
Despite its incomparable efficiency for mAbs capture, the use of the standard affinity media (soft or semi-rigid polymers derived from agarose and polystyrene) directly impacts the productivity numbers by limiting flow rates and capacities. AbSolute® High Cap that re-invent the way to do capture within a mAb process.
Recently, some improvements were performed on the materials to use the media at very high flow rates and providing extremely high dynamic binding capacities. The direct consequence is a decrease of the equipment size for the process itself and a reduction of the overall footprint for the utilities. Another impact is linked to the environment with the decrease of buffer consumption thanks to the use of novel recombinant versions of protein A.
Another technology called Sequential Multi Column Chromatography using BioSc® applicable not only for the capture but intermediate purification and polishing steps as well helps to streamline production processes.
Downstream processes suffer from the lack of productivity mainly due to batch sequences that introduce lot of timeouts all along the process. This technology is based on extremely rapid cycling of the resin enhancing its efficiency when used under batch conditions.
Sequential Multi Column Chromatography targets to reduce required volumes of media, buffers and associated costs. Biosc® is very attractive due to its perfect adaptability to all processes already developed and optimized. This technology replaces batch mode by a highly improved sequenced process in order to utilize 100% of the capacity of the media. Process time, buffer consumption, volume of media, column sizes are decreased with a direct impact on productivity (up to x2 or x3). This technology is adaptable to any upstream volume that can be processed in time.
Both technologies are easily scalable and robust, specially designed for a rapid transfer to production, with a decrease of the associated costs and the risks of scale-up phases that possibly shorten the time to market.
These new paradigms revisit and debottleneck downstream processing. This lecture will analyse traditional capture conditions versus this paradigm for limited production of clinical trial material as well as for large-scale commercial manufacturing of mAbs with improved productivity.
13:00 – 13:30 Lunch/networking and trade show
This is also a good time to fill out your feedback forms and any questionnaires
13:30 – 14:30 Question and Answer Session
Delegates will be asked to submit questions to a panel of experts. Questions can be submitted before the event or on the day
14:30 – 15:00 The use of Chromatography Membranes for the development and scale-up of biopharmaceutical processes
Dr. Juan Pablo Acosta-Martinez, Sartorius Stedim Biotech, UK
Time and simplicity are very valuable elements during the development of any biopharmaceutical product. A rapid process development using minimum amount of material and its facile transfer from small to large scale are two challenges that every company has to face. The Membrane Adsorbers technology offers great number of benefits such as easy handling, high flow rates and easy scale up that makes them a good option for the development and production of biopharmaceutical products.
15:00 – 15:30 Afternoon Tea/Coffee, networking and trade show
15:30 – 16:00 New absorbant nanoparticle technology for continuous chromatography
Dr Daniel Bracewell, University College London¸UK
Electrospun polymeric nanofibres offer a possible solution to limited productivity in downstream processing. Here we fabricate cellulosic nanofibers, which are packed into a cartridge to promote flow distribution and functionalized. The resultant material is more resilient to fouling and can be operated at much higher flowrates for a given pressure drop while maintaining capacity. To utilise these excellent mass transfer properties continuous chromatography is used to offer significant productivity improvements.
16:00 – 16;30 Disposable technologies in Downstream Processing
Mr Andrew Clutterbuck, Merck Millipore, France
16:30– 17:00 Chairman’s summing up
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This meeting was organised by Euroscicon (www.euroscicon.com), a team of dedicated professionals working for the continuous improvement of technical knowledge transfer to all scientists. Euroscicon believe that they can make a positive difference to the quality of science by providing cutting edge information on new technological advancements to the scientific community. This is provided via our exceptional services to individual scientists, research institutions and industry.
About the Chair
John Moys of the Bioprocess Production Division of ThermoFisher Hyclone, has 25 years experience within the industry, in both up and downstream processing. Previously head of Applications Support, North Europe for Sartorius Stedim Biotech, he has 17 years experience with Sartorius across the UK, Europe and Asia. Prior to this, he had accrued over 8 years of practical experience within manufacturing, quality control and R&D for the in-vitro diagnostics and antibody manufacturing sectors.
About the Speakers
Fabien Rousset is responsible for chromatography resins development at Novasep Process. Fabien was from 2004 to 2011 working for PALL Corporation as Resins R&D manager. Prior to PALL Fabien worked for another leading Biopharmaceutical organisation as a specialist materials development scientist with responsibility for new technology developments - resins and membranes. Fabien is a Ph.D graduate from the University of Paris - Chemistry and physico-chemistry.
After graduating from the University of Abertay Dundee with a degree in Biotechnology Stuart Melvilles joined Avecia Biologics (now Fujifilm Diosynth Technologies) working on the technology transfer, process development and GMP manufacture of therapeutic proteins from microbial cells. Following a brief spell working with Biosceptre, a University spin out company in Sydney, and Teva, a small molecule generic company he joined Eden Biodesign in early 2009. He is currently the technical lead for the development of a biosimilar for rhFSH.
Daniel G. Bracewell is a Reader at UCL. He completed his first degree at Imperial College London before moving to UCL where he completed a Masters and PhD in the Department of Biochemical Engineering. Several years in industry followed in both analytical and fermentation development roles before he returned to UCL. He currently supervises 15 doctoral and postdoctoral projects related to the purification and stability of biopharmaceuticals, many of these studies are in collaboration with industry. The common theme is well designed scale-down mimics of unit operations, with appropriate analytical methodology to achieve new levels of process understanding.
Steve Loftus Completed HISdegree in Medical Microbiology at Newcastle University in 2001 before going on to do a PhD in Biochemistry/Biophysics at The University of York. Joined Avecia Biologics in 2006 working on the development and scale up of microbial biologics for GMP manufacture at 1000 and 5000 L scale. Fujifilm acquired the company in 2011 and merged it with Diosynth, North Carolina becoming an industry-leading Contact Manufacturing Organisation.
Juan Pablo Acosta-Martinez is a Chemical Engineering graduate from University of Guadalajara, Mexico and was awarded a PhD in Biochemical Engineering from University College London in 2010. He started his career working in areas such as process engineering and consultancy. He later became the lead bioprocess development engineer in Probiomed, one of the leading biopharmaceutical companies in Mexico. In 2011 he joined Sartorius Stedim Biotech as Project Manager for all activities in the field of Virus and Contaminant Clearance covering all Europe. He has been working on developing clients purification and polishing platforms.
Craig Hart holds a BSc Hons in Molecular Biology from Glasgow University with focus on Molecular and Microbial Biotechnology and Molecular Immunology. After a short spell as a biochemist working at a children’s hospital in Glasgow, Craig joined Q-One Biotech in 1994 within the virology testing team. In 1995 he switched roles to become a member of the viral clearance validation group working alongside clients to perform the downscaled spiked studies of their purification processes latterly in a Study Director role. Craig joined Zeneca in 1997 as a member of the analytical biotechnology team based in Macclesfield with responsibility for chromatographic assays and biosafety testing management. Following the merger with Astra he moved to Sweden in a Senior Scientist role within the Centre of Excellence for analytical biotechnology in Södertälje. In 2004 Craig returned to the process development area as a Senior Scientist in the downstream development group with responsibility for the development of downstream processes for monoclonal antibodies and recombinant proteins. From 2008 Craig has held positions of team manager for the development group and from 2009 to 2011 Team Manager for the full Purification team after the divestment to Recipharm. From November 2011 Craig will take on the role of Principal Scientist within Purification. Craig holds specialist knowledge in biosafety testing, viral clearance studies and regulatory guidance.
Keywords: Purification, downstream processing, primary separation, primary capture, chromatography, filtration, polishing, fill
& finish, Single use Technologies, purification, biopharmaceutical, nanofibres; productivity, Membrane Adsorbers, Scale Up, Process Development, Biosimilars, Process Development,
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