The Penridge Suite, London, N11 1NL, UK : Friday, 16 September 2011 09:00 - 17:00
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 unit operations. This meeting aims to explain each of these unit operations and may offer some possible solutions.
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, Sartorius Stedim, UK
9:00 – 9:45 Registration
9:45 – 10:00 Introduction by the Chair: John Moys, Sartorius Stedim, UK
10:00 – 10:30 Harvest & Recovery of High Value Biopharmaceuticals
Andy Clutterbuck, Eden Biodesign, UK
10:30 – 11:00 Selection and Scale-up of Ultrafiltration Membranes
Martyn Paddick, BPL, Elstree, UK
Considerations for the selection of ultrafiltration membranes and issues regarding the scale up of ultrafiltration processes from lab scale to full production scale.
11:00– 11:30 Mid-morning break, Poster Viewing and Trade Show
11:30 – 12:00 Running a single use platform process - Advantages and Obstacles.
John Milne, Technical Manager, BioUETIKON, Ireland
Within the biopharmaceutical industry single-use technologies are increasingly evolving and becoming commercially available for a wide variety of applications and processing steps. When compared with traditional reusable systems, single-use or disposable technologies can reduce costs and increase flexibility and speed which are important drivers within the industry. This presentation will look at the integration of a single use platform process in a contract manufacturing setting and in particular at the perceived advantages and obstacles that are presented using such an approach. As a contract manufacturing organisation (CMO) specialising in the manufacture of mammalian cell culture derived therapeutics, BioUetikon has seen at first hand the benefit to its development, pilot-production business of adopting a single-use strategy. The flexibility to incorporate a variety of projects by utilising existing facilities with reduced turnaround times has been deemed advantageous by clients and satisfies the obvious need for a competitive business approach to the Company. Some practical challenges to the efficient incorporation of disposable consumables will be considered using the example of the manufacture of a therapeutic monoclonal antibody for a recent clinical trial.
12:00 – 12:30 Sequential Multi-column Chromatography.
Chris Davis, Process Group Manager, Mott MacDonald, UK
Whilst there have, over the last 10 to 20 years, been significant developments in the area of upstream processing there have been fewer developments in the area of purification. The development of sequential multi-column chromatography has the potential to offer significant cost reductions over traditional column chromatography. The presentation will report on a desk-top study evaluating this new technology.
12:30 – 13:30 Lunch, Poster Viewing and Trade Show
13:30 - 14:30 Question and Answer Session and Speakers photo
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 Affinity Platform Approaches for the Purification of Non-Antibody Bio-Therapeutics
Sharon Williams, Product Development and Downstream Processing Manager, ProMetic BioSciences Ltd. UK
Non-antibody proteins represent 65% of the bio-therapeutics market and include growth factors, hormones, cytokines, plasma proteins, therapeutic enzymes and protein vaccines. Whilst Protein A has provided a useful affinity capture platform for monoclonal antibody purification, equivalent platforms for non-antibody molecules have proved elusive.
Synthetic ligands, obtained through the use of computational chemistry and ligand library screening can be targeted to almost any protein. Such ligands provide a means of capturing and purifying non-antibody proteins and are also very robust and can be reused for many purification cycles. Ligands may be generated by screening general ligand libraries, modelling known binding compounds or identifying potential ligand binding sites on the protein of interest and modelling complementary binding ligands in-silico. Techniques such as molecular docking provide useful tools for predicting how potential ligands might interact with a particular region of a protein and virtual screening algorithms can be used to pre-select potential ligand candidates for synthesis and in-vitro screening.
15:00 – 15:30 Afternoon Tea/Coffee, Last Poster Viewing and Trade show
15:30 – 16:00 Innovative Technologies for Downstream Biomanufacturing
Omar Wahab, Sartorius Stedim, UK
The separation of different biomolecules from the functional drug product is fundamental when designing any biopharmaceutical manufacturing process. This separation should leave a high purity drug product of high efficacy, but still maintain a recovery that leaves the process economical at campaign scale. The downstream processing has seen many challenges over the past few years; from handling high product titres into the so called “purification bottle neck” to running single-use platforms. The recent surge in single-use technologies has helped reduce personnel, validation costs and risk to product safety, as well as reducing time to market. This presentation will discuss some of these cutting edge single-use technologies/hybrid systems in the downstream purification process, and give an insight to the process economics of such technologies.
Examples of technologies used in the manufacture of recombinant proteins, monoclonal antibodies and vaccines will be shown together with detailed case studies for the separation of impurities such as host cell proteins, DNA, viruses, endotoxins, detergents and aggregates from the target protein. Membrane chromatography is fast becoming a preferred choice for the polishing chromatography step. This technology will be discussed in detail, alongside the new trends in more longstanding technologies such as depth and crossflow filtration. Finally novel technologies for virus inactivation will be discussed, such as Ultraviolet – C Irradiation and automated systems for the low pH holding step will be presented.
16:00 – 16:30 A novel chromatography technique for purifying large molecules
GE Healthcare
By designing layered beads with different ligands in inner and outer layer new properties and features of the chromatography resins can be obtained. Layered beads has potential to give unique functionalities and solve difficult separation problems as well as improve process economics. Examples with novel resin designs and their properties are shown, and with examples on how layered beads can improve process economics and throughput in vaccine processing. Many downstream vaccine processes in current production either use centrifugation with sucrose gradients or size exclusion chromatography as unit operations in the purification strategy, with limited throughput. The presentation will show how impurities such as host cell proteins and DNA fragments are eliminated in one single chromatographic step with layered beads using multimodal ligands in combination with size exclusion. Process examples of this generic process will be shown with purification of human influenza virus, as well as adeno virus.
16:30 – 17:00 Implementing biologics filling with implementation of single use systems
Brendan Fish, GlaxoSmithKline, UK
17:00 Chairman’s summing up
Media Partners
About the Chair
John Moys is the head of applications support, North Europe for Sartorius Stedim Biotech. He has over 15 years experience with Sartorius in both technical and commercial roles and has carried out projects in the UK, Europe and Asia. Prior to joining Sartorius he had over 8 years working in industry in manufacturing, quality control and R&D roles in the in-vitro diagnostics and antibody manufacturing sectors.
About the Speakers
Omar Wahab started his career working at Abbott Laboratories, where he worked in downstream process optimisation and technical transfers. In 2007 Omar moved to Sartorius Stedim to take over the role as downstream process development specialist covering North Europe. He has been working on developing client’s downstream manufacturing platforms and incorporation of new technologies.
Martyn Paddick is a Project Scientist at Bio Products Laboratory Ltd working on the development of intravenous immunoglobulin products.
John Milne is a Science graduate from University College Dublin and was awarded a PhD in Biochemistry in 1996. Following a series of postdoctoral research positions in the areas of molecular enzymology and protein chemistry, he joined BioUetikon Ltd (formally Archport Ltd.) in 2000 employed as Downstream Processing Manager specialising in the development, optimisation and validation of protein purification protocols for molecules proceeding to clinical trial and commercial manufacture. Following an investment 2007 by CPH Chemie + Papier Holding AG he has been employed as Technical Manager responsible for technical operations and supporting new project assessment. BioUetikon provides high quality process development, optimisation and Bioproduction services for mammalian cell culture derived therapeutics in a multi-suite GMP certified facility.
Chris Davis, Process Group Manager for the Nuclear and Process Division of Mott MacDonald, and is a chartered chemical engineer with 21 years of experience in process engineering, consultancy, and design management on projects of every scale in the biopharmaceutical industry. He has been involved in all stages of process development, production operations, design, commissioning, and validation. His responsibilities have included consultancy and concept studies, feasibility, preliminary engineering, detailed design, installation, and validation.
Brendan Fish is Director of New Product Introduction and Process Technology for GSK at Barnard Castle. With a career spanning over 20 years, he was Director of Bioprocess Sciences at MedImmune Cambridge where he was responsible for all aspects of the development of purification methodologies, product characterisation, QC, formulation and delivery for MedImmune products in relation to their use in commercial pharmaceutical processes. This included initial design and optimisation, scale-up, process cost modelling, process integration and technology transfer to GMP Production for clinical trial supply. Brendan was also at Delta Biotechnology Limited as a Consulting Scientist. He played a key role in the development of their biotechnology-based products providing expert opinion and strategies for QA, QC, Production, Marketing, Operations, Regulatory Affairs and Engineering on all aspects of Process Development. Early in his career, he was a Post-doctoral fellowship at University of Toronto in Canada working in the School of Nutritional Sciences, studying the anti-nutritional effects of lectins in the diet
Sharon Williams is the Product Development and Downstream Processing Manager for ProMetic BioSciences Ltd. This is a biotechnology company that produces and supplies materials for the production and purification of biopharmaceuticals and for the capture and removal of bio-contaminants. Her role is to manage the development of new products from conception to product launch and subsequent use in the field. She also oversees the development downstream processes using these materials.
She has been working in downstream processing since she started her PhD in the Biochemical Recovery Group at University of Birmingham, where she investigated adsorbent design for nanoparticle recovery. She continued this work as a Post Doctoral Research Associate at the University of Cambridge where she investigated the affinity purification of viruses.
Keywords: Purification, include downstream processing, primary separation, primary capture, chromatography, filtration, polishing, fill & finish, Single use Technologies, chromatography, purification, biopharmaceutical
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Registration Web Site: www.regonline.co.uk/downstream2011
Post expires at 7:48am on Friday September 16th, 2011
