9:00 – 9:45 Registration
9:45 – 10:00 Introduction by the Chairs: Dr John J.S. Cadwell, President and CEO, FiberCell Systems Inc, USA
10:00– 10:30 Production in hollow fiber
Vincent Dewar GSK
10:30 – 11:00 Talk title to be confirmed
Professor Robert Edwards, Durham University, UK
11:00- 11:10 Speakers photo
11:10 – 11:30 Mid-morning break
11:30 – 12:00 Talk title to be confirmed
12:00 – 12:30 Moving from the flask to proof of principle - what regulatory questions do I have to answer?
Dr Colin Love, BioVex UK
12:30–13:30 Lunch and Poster Viewing
13:30 – 14:00 PAT and Quality by Design – a Process SystemsEngineering View
Professor Julian Morris, Technical Director CPACT and Professor of Process Control, Centre for Process Analytics and Control Technology, Newcastle University, UK.
Unlike in off-line assays, in-situ or on-line real-time spectroscopic measurements are almost inevitably subjected to fluctuations/variations of process variables such as temperature as well as sample compactness, instrumental effects and other external process variables and physical properties of samples. This makes the task of extracting the relevant chemical information, and ultimately reliable process understanding for process modelling and for closed loop process control and optimization, from spectroscopic measurements well beyond being routine in pharmaceutical manufacturing. Challenges also relate to the routine integration (fusion) of analytical and process sensor based chemical and biological measurements which may be dynamic, nonlinear and of disparate forms. All these exacerbate the building robust, transferable, calibrations (models). The presentation will discuss the application of recently developed multivariate methods to enable the assured application and on-line real-time use of process analytics for process monitoring and control.
14:00 – 14:30 Coproduction of biopolymers consisting of Medium chain length 3-hydroxyalkanoic Acid and Exopolysaccaride by Pseudomonas CMG607w of marine origin
Nazia Jamil Department of Microbiology and Molecular Genetics, University of the Punjab, Lahore-54590, Pakistan
14:30 – 15:00 Selected oral abstracts
15:00 – 15:30 Afternoon Tea/Coffee and Last Poster Viewing
15:30 – 16:00 Gram Quantity Production of Monoclonal Antibodies and Recombinant Proteins in a Hollow Fiber Bioreactor System
Dr John J.S. Cadwell, President and CEO, FiberCell Systems Inc, USA
16:00 – 16:30 Talk title to be confirmed
17:00 Chairman’s summing up.