A Speedier Process

By Tony Kontzer  |  Posted 2009-09-29 Print this article Print

Companies in the life sciences industry are adapting key technologies to fit their very specific business process environments.

A Speedier Process

In the world of contract pharmaceutical manufacturing, success hinges on two things: the ability to produce quality drugs that meet all the necessary requirements and the ability to do so quickly. More often than not, the two are inextricably connected. This explains why, in March 2008, Catalent Pharma Solutions decided to sell off its sterile injectables unit: It wanted to shed the drag that the much slower injectables business had on its bottom line.

The founders of the new business that resulted, Albuquerque, N.M.-based Oso BioPharmaceutical Manu-facturing LLC, knew that it would have to be as efficient as possible if it wanted to stand out as a contract manufacturer of injectables. The company started with a strategic IT investment, purchasing Sparta Systems’ TrackWise quality management software and configuring it to speed up the investigation of deviations found while manufacturing batches of injectables, called “lots.”

Oso’s TrackWise deployment essentially provides a template for performing those investigations. It gives staff the ability to survey information from the company’s document management and training systems, all from within TrackWise. This makes it easier to access the critical information the company needs to determine what led to the deviation.

As a result, Oso is able to identify and correct deviations in lots much quicker than it could before. When a production line worker forgets to turn on a probe that removes airborne particulates such as dirt and dust from the air, or when an operator doesn’t record how much active ingredient was added to a compound, the system streamlines the investigatory process by requesting and discovering all the needed information via one template.

“It’s basically a timing thing—it streamlines the business process from a quality assurance [standpoint],” says Brian Board, director of quality systems. The impact, according to Board, is “immeasurable. It makes our lives easier on a daily basis.”

As immeasurable as it may be, TrackWise has actually had a very measurable impact on Oso’s business. Since it was deployed, the software has not only provided that unified interface, but it has also enabled Oso to further reduce IT costs by eliminating about 60 percent of the custom functionality that had been built into its document management system.

Even more important is the fact that this streamlining of business processes allowed Oso to reduce the time needed for releasing injectable lots from as long as 90 days to just 30 days. That’s the kind of difference that can mean beating out the competition forcontracts to produce everything ranging from infertility injectables to vaccines.

Whether the objective is to crunch and disseminate data more effectively or to be more efficient in investigating deviations during the drug development process, strategic IT investments are helping life sciences companies speed up their responses to the demands of a fast-moving market.

That’s no easy feat for an industry that is characterized by complex development formulas and unwieldy regulations. However, a business-as-usual approach no longer works in a world of real-time decision making.

Tony Kontzer is a freelance writer for Baseline magazine.

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