Recovery and purification of biosynthetic products: Downstream processing for the 21st century - 27 November 2013

The growing interest in biotechnology development and the high demand for biopharmaceuticals have contributed to the growth of the global biopharmaceutical market, which now comprises over 200 prodcuts. This market has reached $106 billion in 2009 and is forecasted to grow with a CAGR of 11.2% by 2016.

The main challenges of the biopharmaceutical industry now are to increase the efficiency and reduce the costs of the manufacturing process, with respect to the protein recovery, purity and efficacy. Therefore, new strategies are being implemented for the upstream and downstream processing. In the upstream, genetic engineering and glycoengineering approaches, as well as single-use bioreactors are being developed and applied. However, as culture yields are continuously increasing, the bottleneck in the manufacturing process has shifted to the dowstream processing, which accounts for ~ 80% of the total production cost. Many aspects are being considered for improving economics in downstream processing, such as simplification of the chromatographic purification processes, application of membrane technology, crystallization and precipitation.

This meeting will focus on the advances, innovation and challenges in the area of downstream processing of biopharmaceuticals.

This event has CPD accreditation and is part of
The 2013 BioProcessing Summit - www.BioprocessingSummit2013.com

Meeting chair: Dr Graziella El Khoury, University of Cambridge, UK

Who Should Attend
Biotech and Pharma Industry: CEOs, Chief Scientists, Group Heads, Senior and Junior Scientists, Research

ManagersAcademic and Research Institutes: Group and Lab Heads, Postdoctoral Scientists and Research Students

The Deadline for abstract submissions for oral presentation is July 10th 2013
Abstracts for poster presentation only can be submitted up to two weeks before the event
You can download the instructions for authors at
www.euroscicon.com/AbstractsForOralAndPosterPresentation.pdf

Talk times include 5 – 10 minutes for questions

9:00 – 9:45 Registration

9:45 – 10:00 Introduction by the Chair: Dr Graziella El Khoury, University of Cambridge, UK

10:00 – 10:30 Advances in Therapeutic Protein Purification.
Dr Graziella El Khoury, University of Cambridge, UK

As the upstream titres of therapeutic proteins are continuously increasing, one of the major challenges of the biopharmaceutical industry now is to reduce the cost of the dowsntream processing, which typically accounts for ~ 80% of the total production cost. However, the purification process needs to be reliable to produce highly pure, bioactive proteins suitable for human use. This talk will highlight recent advances in therapeutic protein purification, with specific examples on the downstream processing of top selling biopharmaceuticals, including monoclonal antibodies (mAbs) and recombinant human erythropoietin (rHuEPO).

10:30 – 11:00 Fitting non-platform products into platform timelines Dr Alison Tang, Medimmune DSP, Cambridge,UK

11:00 – 11:30 Speakers’ photo then mid-morning break and poster exhibition and trade show

11:30 – 12:00 Semi-selective protein precipitation using salt-tolerant copolymers for industrial purification of therapeutic antibodies Mr Florian Capito, Institute for Organic Chemistry and Biochemistry, Technische Universität Darmstadt, Germany

Semi-selective precipitation employing customized salt-tolerant ionic copolymers was evaluated as antibody (mAb) purification step. Precipitated mAb was easily re-dissolved in small volume, enabling concentrating mAb up to hundred-fold, while residual polymer could be removed to > 98 %. mAb recovery of > 90 % and host cell protein clearance of > 80 % were achieved, not requiring any pre-dilution of the cell culture fluid. Precipitation showed no impact on mAb binding affinity. Compared to protein A based purification, yield and purity were lower; yet for high titer processes already being implemented, precipitation is more cost-effective and easier to scale.

12:00 – 12:30 Oral Presentations

12:30 – 13:30 Lunch, poster exhibition and trade show

13:30 – 14:30 Question and Answer Session

14:00 – 14:30 Liquid-liquid extractions of proteins. Batch or continuous? A past or a future? Professor Derek Fisher, Brunel University, UK

14: 30 – 15:00 Afternoon Tea, last poster session and trade show

15:00 – 15:30 To be confirmed

15:30 – 16:30 Bacillus protein secretion, an aid to downstream processing Professor Colin R. Harwood, Centre for Bacterial Cell Biology, Institute for Cell & Molecular Biosciences, Newcastle University

Bacillus species are prolific secretor of proteins that are directed into the culture medium. The main secretion pathway, the Sec translocase, requires targeted secretory proteins to be in a translocation competent, substantially unfolded, state. Consequently, secretory proteins must fold as they emerge on the trans side of the membrane. While this has the advantage of facilitating their folding into their native and therefore functional configuration, it adds an element of vulnerability to proteins that intrinsically fold slowly. Approaches to address this issue and improve the yield of proteins in the culture medium will be discussed.

16:30 - 17:00 Chairman’s summing up

Registration Web Site: www.regonline.co.uk/down2013

About the chair:

Graziella El Khoury received her MSc degree in Physiology and her PhD in Biotechnology from the University of Lyon, France. Her PhD thesis focused on the implementation of miniaturised immunoassays for peptide and protein microarrays. She is a Postdoctoral Research Associate in the Department of Chemical Engineering and Biotechnology working on the development of synthetic ligands for affinity chromatography and the downstream processing of biopharmaceuticals. She has been awarded the “Journal of Molecular Recognition Year Travel Award for a Young Scientist” at the 19th Biennial Meeting of the International Society for Molecular Recognition - Affinity 2011.

About the speakers:
Colin Harwood is a graduate of London and Leeds Univerities and is currently Professor of Molecular Microbiology at the Centre for Bacterial Cell Biology, Newcastle University. He has studied Bacillus protein secretion for more than 25 years and Bacillus molecular biology for more than 40 years. He has collaborated widely with some of the major producers of industrial enzymes, and uses his knowledge of the fundamental processes involved in protein secretion to engineer strains with increased yields.

Florian Capito’s current scientific focus is on new purification strategies within production of biotherapeutic proteins, bioanalytics and bio- process monitoring. After obtaining his Bachelors degree in molecular Biology at Johannes- Gutenberg University Mainz, he did his Masters in Proteinscience at Lunds Universitet, Sweden, before starting his PhD thesis at Technical University of Darmstadt in conjunction with Merck KGaA, which he will finish beginning 2014. Besides his current research, his expertise is within protein-structure modeling, structure- function comparison, protein bioinformatics and protein chemistry.