Firstly, Happy New Year! Please help yourself to a slice of cake.
In all areas of pharmaceutical development, one of the recurring challenges is scale-up, so of particular interest was a thought-provoking talk given by Roslin Cell's Aidan Courtney on scaling up cell manufacture from the point of view of translating research protocols into GMP processes. He noted, "the destination defines the journey," i.e., depending on the application of a particular cell therapy, the quantity of cells required for treatment becomes a crucial parameter. Courtney went on to provide numbers for a couple of example scale-up scenarios; ischemia therapy would probably require 108 cells per treatment, so estimating perhaps 10,000 treatments per year, the numbers start multiplying faster than the cells... He concluded that GMP translation and scale-up are challenges best addressed in tandem.Bridging the gap between discovery into development and onto commercial scale manufacturing is something that our sister publication, BioPharm International, is addressing in collaboration with BIO SmartBrief: "Drug Development Basic Training". I encourage you to check out some of the weekly articles and podcasts at http://BioPharmInternational.com/biosmart/ and to sign up for BIO SmartBrief.
I leave you with the passionate words of this year's winner of the Peter Dunnill Award, Professor Mike Hoare from University College London, who concluded in his bioProcessUK presentation on ultra scale-down for enhanced bioprocess discovery: "Design for manufacture; design for lower cost."