The BioPark, Hertfordshire, AL7 3AX, UK
24th Feb 2011
This event has CPD accreditation and will have a troubleshooting 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 9:00 – 9:45 Registration 9:45 – 10:00 Introduction by the Chair: Dr Brendan Fish, NPI-PT Director at GSK Barnard Castle 10:00 – 10:30 Faster, cheaper, better: How novel approaches are helping develop biotherapeutics for tomorrow.
Developing successful biotherapeutics takes many years and is a costly process. Time to the clinic can be reduced by improving efficiency of the processes used at each stage of the drug development cycle and cost of goods can be decreased by optimising manufacturing processes. This talk focuses on some strategies and new technologies which have been adopted at MedImmune to streamline and optimise our cell line development and upstream production processes. 10:30 – 11:00 Slonomics Technology - Generation of Multiple Length Variants in Synthetic Antibody Libraries
Dr. Thomas Waldmann, Sloning BioTechnology GmbH, Germany
Traditional research has focussed on process development to improve therapeutic protein yield and quality. Another more recent approach is to engineer the genes themselves to obtain the desired protein - a process known as directed evolution. The Slonomics® technology platform generates highly diverse and precise combinatorial libraries for such protein engineering. Unlike traditional mutagenesis methods that rely on single stranded oligo nucleotides, the process uses double stranded DNA triplets as universal building blocks for the synthesis of any gene sequence - 'one amino acid at a time'. For library production, a mixture of codons can be introduced at any desired sequence position, in any combination and at any ratio. The absence of functional bias and the sequence independent synthesis process result in exceptionally high quality libraries containing the complete set of desired mutants. Any sequence position can be mutated individually, in a stretch, or in multiple sequence combinations. In addition, individual mutation patterns can be uniquely combined with length diversifications or randomly mutated sequence regions. 11:00- 11:10 Speakers photo 11:10 – 11:30 Mid-morning break and poster viewing 11:30 – 12:00 Strategies to decrease cell line development - a review of the current technologies Dr Jenny Thirlway, Eden Biodesign, Liverpool, UK One of the largest lead times in moving a biological drug candidate from the bench to a ‘first in man’ clinical trial is the development of a stable, high expressing production cell line. Here we present a strategic review of the key activities required to develop a cell line and discuss the pros and cons of the current proprietary technologies (including generation of cDNA, expression technologies and clone screening & selection) that are used to compress the timelines for cell line development. , 12:00 – 12:30 Talk title to be confirmed
Dr John Moys, Sartorius Stedim, UK
12:30–13:30 Lunch and Poster Viewing 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 Forced degradation studies of proteins formulated by high-throughput techniques Dr. Paul Dalby, University College London Microplate-based, and increasingly microfluidic platforms, enable very small quantities of proteins to be analysed under a wide range of formulation, stress and bioprocess conditions. A platform of automated high-throughput methods for pre-formulating protein conformational stability, solubility and tolerance to freeze-drying will first be introduced. Their application to pre-formulation, the design of bioprocesses and the early identification of problematic protein leads will be discussed. The benefits and current limitations of high-throughput approaches for gaining increased understanding of protein behaviour will also be discussed by comparison to forced degradation results and further detailed biophysical analyses of proteins in solution. 15:00 – 15:30 Afternoon Tea/Coffee and Last Poster Viewing 15:30 – 16:00 Quality Issues, Guidelines and Requirements for Biological Products Charles Christy, Covance Laboratories Ltd¸ Harrogate, UK The talk will cover the range and specific details of analytical testing that is currently required for biological products with specific reference to cell line release, process validation for contaminant clearance (virus, HCP, rDNA), and to characterise, ensure batch-to-batch consistency and appropriate product stability. This talk will cover the regulatory requirements and the relevant guidelines for both the EMEA and the FDA for biological therapies. Finally the talk will give guidance on the most appropriate analytical techniques required to demonstrate product consistency, purity, safety and potency. 16:00 – 16:30 Regulatory aspects of therapeutic protein production Dr Stephen Thompson, S-cubed Ltd, Oxfordshire, UK The evolution of regulation of biological products has resulted in the key concept of ‘the process is the product, and the product is the process’. Biotech products are complex and diverse, resulting in a ‘case by case’ approach to assessment. While there is an absence of useful precedent in the regulatory requirements for biologicals, there is more scope for devising development programmes based on knowledge of the product and process. This presentation will cover the regulatory requirements and relevant guidelines for biological therapies, and the evidence require to meet regulator’s expectations for a well-characterised product and well-characterised process. 17:00 Chairman’s summing up.
|