Between change and reality

How much more regulation can the pharmaceutical industry bear? That was one of the questions addressed at the recent Chemgineering pharmaceutical symposium. To keep the answer short and simple: Not much more. Even worse, regulations, lagging far behind technical developments, are in urgent need of adaptation to current circumstances. The head of Chemgineering Dr. Herbert Matthys hit the nail on the
head stating that almost nothing had changed in process engineering for 150 years. Even now, he said, discontinuous systems are being used although continuous processes—and hence microreactors—could bring enormous progress in terms of process and cost optimization. It was not the technical possibilities that were the limiting factor, he maintained, but rather the traceability demanded by the authorities, traceability that could not be guaranteed as a matter of course in continuous processes. The situation with biopharmaceuticals was even more precarious, said Dr. Friedrich Nachtmann of Sandoz. Processes had to be finalized as early as for products going into the clinical phase III it was not possible to change the processes and procedures afterwards. The result? Companies have to carry an almost unconscionably high risk.

However, there are chinks of light ahead. “Cost dampers” can play a part to enable production to be competitive at international level. A first point of attack is system concept design: optimal size, the decoupling of reactor and processing facility, a high level of automation. It delivers much shorter production cycles and a high standard of product quality. This explains why billions of Euros still pour into European biotechnology. Good examples are the investment by Roche in Biologics III/IV in Penzberg (see page 10) and by Pfizer from Illertissen in the production of highly effective drugs (both in Germany), including a new treatment for osteoporosis. The recent refusal by the FDA to license this drug demonstrates the great risk of such projects.
While on the subject of automation, the Working Group on Pharmaceutical Process Engineering (APV) in Mainz (Germany) started a study in conjunction with the Institute of Technology Management in St. Gallen (Switzerland) aiming to determine the importance attached to operative excellence by the pharmaceutical industry. The results of the study also put a finger on the automation wound: the extremely high quality standard in pharmaceutical production is not the result of seamless quality management, but rather the consequence of enormous expenditure on monitoring and controls. The underlying fact is that merely documenting a process falls a long way short of improving it.

-Thomas Röhl-