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Clinical Trials, Pilot Plants and Automated Rapid Detection

Posted by Admin User on January 13, 2011

Over the holidays while I was catching up on my reading I came across an article from back in 2009 that noted that the average time for the clinical and approval phases of drug development is approximately 8 years.  Many factors contribute to this time window, but any reduction in time can have a significant impact to revenue and productivity.

When we speak to companies about their challenges in pharmaceutical manufacturing, the conversation usually focuses on the manufacturing process for approved drugs.  It makes sense, since this is where most tests are performed and often where the most opportunity lies.

I’ve come to realize that the clinical phase represents a key opportunity for automated rapid microbial detection, specifically in the pilot plants.  These often overlooked facilities are running multiple products in small batches through their fermenters and bioreactors in preparation for clinical trials. 

As an example, a small batch of clinical trial product A may run, with clinical trial product B to follow.  In between these runs, the fermenter or bioreactor has to be carefully cleaned.  Some of the tests associated with the quality control can take as long as 7-10 days to uncover contamination.  And, if there is contamination, a timely investigation must be performed. 

Imagine what a reduction in the time could mean to this process.  What would it be worth to a pharmaceutical company if they could get one more drug into clinical trial during the calendar year using the same infrastructure?  Thousands of dollars? Millions of dollars?

The pilot plant is a prime area for increased value through rapid detection.  Reducing detection times can mean faster lot releases, increased drug throughput, and improved ability to process and investigate samples. Ultimately, this accelerates the return to service of equipment in the pilot plant, keeping the clinical trials on schedule.

Considering the investment that pharmaceutical manufacturers make to bring drugs to market, increasing the payback of a pilot plant through rapid automated detection is compelling.  Sign up for a free assessment of your pilot plant to see if rapid microbial detection can add value.

Julie Sperry
Chief Commercial Officer
Rapid Micro Biosystems