Rapid scale-up of pharmaceutical processes- Finding the trees in the forest
Multi-scale and/or multi-disciplinary approach to process-product innovation
Multiscale Modeling (T3-5)
Keywords: Scale up, Batch Process, Process Development, Konowledge Management
S. J. Lawton, AstraZeneca UK
The development of chemical processes for the manufacture of pharmaceuticals in early development is fraught with challenge for the practicing chemical engineer, particularly given the attrition rate of projects typical of the industry.
Scale-up is further hindered by the small quantities of material available for investigating such problems that may or that do arise.
AstraZeneca has developed an approach to the scale-up of some key unit operations, such that the knowledge of processing characteristics increases in-line with the increasing maturity (and hence likelihood of success) of a product.
By matching the investment in investigator resource to the business risk in the product and by providing a template approach, gains in both efficiency and effectiveness can be made.
Such an approach is known within AstraZeneca as a toolbox. This incorporates basic education on unit operation principles as applied within the company combined with common laboratory equipment and standard experimental methodologies to provide all locations with common capability. Finally, there are sets of pre-constructed mathematical models that provide a common language for the communication of information, removing the unnecessary duplication of effort when predicting performance at plant scale.
The Toolbox approach will be introduced; along with a case study to illustrate it’s use.
See the full pdf manuscript of the abstract.
Presented Tuesday 18, 09:45 to 10:05, in session Multiscale Modeling (T3-5).
