3rd Annual Modern Challenges in Therapeutic Protein Production Event
14th June 2012
The purpose of this annual event is to look at the challenges facing therapeutic protein production and demystify some of the novel approaches and new technologies currently being developed
This event has CPD accreditation and will have a troubleshooting panel session.
Meeting Chair: Alison Mason, MedImmune, Cambridge
A decision-support tool for the optimal design of multi-product biopharmaceutical facilities
Dr Sofia Simaria, Advanced Centre for Biochemical Engineering, Dept. of Biochemical Engineering, University College London
Increasing pressures exist for the design of flexible and cost-effective multi-product facilities that can cope with diverse biopharmaceutical drug candidate characteristics and process variations. A computer-based decision-support tool using optimisation algorithms has been developed and applied to an industrially relevant case study on the production of therapeutic monoclonal antibodies. The most cost-effective purification sequences and chromatography column sizing strategies that meet demand and purity targets for each product in the facility are identified and graphical methods incorporated in the tool allow the visualisation of trade-offs in the set of optimal solutions so as to enhance the decision-making process .
Lessons learned for installation and operation of a 2000L SUB
David Wolton, CMC Biologics A/S, Denmark
CMC Biologics, an independent contract manufacturer of biological APIs, has installed the first-in-Europe Hyclone 2000L single-use-bioreactor for cGMP manufacturing of biotherapeutics in their Copenhagen facility. This presentation details the practical lessons learned from installation and qualification of large-scale SUB technology
Use of homologous recombination based gene engineering for CHO cell line optimization.
Joshua Kapp, Product and Business Development Manager, Horizon Discovery Ltd, Cambridge, UK
Since the sequencing and draft genome assembly of the CHO-K1 cell line was published in Nature Biotechnology in July 2011, it has set the stage for routinely modifying the CHO genome to improve the production of recombinant antibodies. Certain key genes such as FUT8, which encodes α 1,6 fucosyltransferase, an enzyme that catalyzes the post-translational fucosylation of expressed proteins, have already been targeted using gene engineering techniques to prevent fucosylation of recombinant antibodies. Many other proteins encoded by the CHO genome, however, have yet to be explored for their potential impact on the efficacy, safety and half-life of recombinant proteins. Horizon Discovery’s proprietary gene targeting platform enables routine modification of the CHO genome to develop the next generation of stable modified host cell lines.
Dave Simpson PhD, Chief Operating Officer, Glythera Limited, TBC, Sartorius Stedim UK Limited
Dr Alison Porter PhD, Head of Cell Line Development, FUJIFILM Diosynth Biotechnologies UK Limited
About the chair
Alison has been working in the Cell Sciences group at MedImmune for the past 11 years, most recently as a senior scientist within the Cell Sciences group.
Alison and her team work on development of cell culture media, feeds and bioreactor processes suitable for GMP production. The team also has a keen interest in implementing scale-down bioreactor systems which mimic a larger bioreactor at the millilitre scale.
Previous to Alison’s position at MedImmune she worked at Lonza Biologics for 2 years as a Fermentation Scientist. Alison holds a degree in Applied Microbiology from the University of Manchester.
About the Speakers
Joshua Kapp heads the Bio-production Business unit at Horizon Discovery Ltd. Joshua was previously involved in the planning of the company’s diagnostics reagents division which has become a cash generating business within 12 months. Horizon Bio-production applies a patented homologous recombination-mediated gene-editing platform exploiting the unique precision of rAAV targeting vectors to the field of bioprocessing through the provision of custom host cell line engineering services. Joshua has a background in preclinical medicine and business, attending medical school at Guy’s and St Thomas’ Hospital in London and business school at Imperial College’s, London Business School.
Sofia Simaria, an Industrial Engineer by training and is post-doc at UCL developing computer-based decision-support tools that capture the process-business interface of biopharmaceutical manufacture. She has been working on collaborative TSB funded projects between UCL and major biotech companies (eg MedImmune, Lonza) and has joined the newly formed EPSRC Centre for Innovative Manufacturing on Emergent Macromolecular Therapies at UCL.
Keywords: Gene correction/modification, AAV vectors, Cell line engineering, biopharmaceutical manufacturing processes, antibody purification, process economics, genetic algorithms, multi-product facility design, homologous recombination, cell line engineering, CHO cell lines, gene targeting, endogenous genome
Expected Number of Attendees
View Conference Website: 3rd Annual Modern Challenges in Therapeutic Protein Production Event
Price of Attendance
The Penridge Suite
470 Bowes Road