From the Editor: Control = Survival

Aug. 30, 2005
Pharmaceutical process control is advancing, but will its progress be fast enough?
By Agnes Shanley, Editor in ChiefThe Ice Age marked a turning point in human evolution. As temperatures plunged and Homo Sapiens arrived on the scene with projectile weapons, warm clothing and enclosed living spaces, Europe’s cave-dwelling Neanderthals died out.Today, the drug industry faces its own version of the Ice Age, as slower R&D pipelines and competition challenge manufacturers as never before. The U.S. public would argue that drug companies have created these problems. Why else would a jury have demanded a $250-million penalty in Merck’s first Vioxx case, or a District Court judge agree to a national class-action suit charging drug makers with “defrauding consumers?”Whatever its source, the juggernaut facing the industry is unstoppable. No drug company today will be immune from competitive pressures. Even Pfizer could not cushion the impact of two drugs coming off patent, and will be eliminating manufacturing and R&D jobs at a number of its facilities. The company, with its Right First Time and PAT efforts, leads the industry in efforts to modernize drug manufacturing, and is now spearheading an industry effort to standardize the IT and control interfaces for PAT. Abbott, which also has advanced PAT programs in place, is cutting jobs.Operators
don’t usually trust
advanced process control
at the beginning.
With training, though,
they learn to appreciate
the beauty of
a good algorithm.
How are they, and how can you, respond to all this uncertainty? By taking control of the processes you do have control over instead of maintaining the status quo.We’ve already seen where the status quo leads. Last month, it led the generics manufacturer Able Laboratories to leave the business altogether; the company had already recalled all its products after a blistering FDA site inspection last May.Some of the problems that FDA found at Able’s site were huge. It seemed that management was so focused on increasing output that it lost sight of the reasons for manufacturing drugs in the first place. Able’s QC unit, for example, was not given the authority to investigate, fully, any quality issues, and there were no procedures in place for determining the root causes of product variability.Clearly, Able’s was an extreme case. But, at any facility pressed to do more with less, there is a limit to what even the most motivated individuals can do. That is one reason why so many other industries have turned to automation and more advanced forms of process control.By connecting sensors to any manufacturing process in progress, Process Analytical Technology (PAT) provides drug makers with access to the same automation that chemicals, electronics and food industries have been using for years.And that automation includes advanced process control (APC) (see our cover story). APC may not be a panacea but it could take more of the guesswork, and error, out of drug manufacturing. At Technion University, a team is studying what a combination of APC and Six Sigma could do for biopharmaceutical manufacturing. (To check on the results they’ve seen so far search on “yield enhancement” at don’t usually trust APC at first, and tend to shut off the controls during upsets. With training, though, they learn to appreciate the beauty of a good algorithm. And algorithms have proven their worth in life-and-death environments. At Chicago’s Cook County Hospital, the inspiration for the television series "ER," doctors have been using an expert system to help with triage. Instead of sending anyone with chest pain to the ICU, they use an algorithm to evaluate patients. Tests show it has never been wrong.As manufacturing professionals, you must seize control of what you can. But as competitive pressures intensify, better process control technology, including APC, can only help. It may mean the difference between extinction and success — and not just for your facilities and companies but for the industry as we know it. Time is running out.