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A Perspective on the Opportunities for Pharmaceutical Quality Control

Posted by Admin User on November 5, 2010

It has been an exciting first few months for me since I joined Rapid Micro Biosystems as the chief commercial officer.  During that time, I’ve had several great opportunities to speak with executives in the pharmaceutical manufacturing industry at two different conferences (the Next Generation Pharmaceuticals Summit and PDA’s global microbiology conference), as well as in one-on-one customer meetings.  These meetings have allowed me to develop a good understanding of the challenges faced by pharmaceutical manufacturing and how automated rapid micro detection can offer significant operational value.

The two common themes among executives are a focus on lean initiatives and operational performance, as well as reduction of the risk of a contamination event within the pharmaceutical manufacturing process. As I have spoken with these executives, I have learned that typically the micro quality control lab is one area that has not been actively addressed as part of their lean initiatives.   In fact, one executive shared with me that his company’s lean initiatives had improved the production processes to the point that the micro QC step became the bottleneck for production release.

The good news for this executive and others are that opportunities exist to reduce micro QC testing times, and eliminate the tedious, manual practices involved in micro QC testing.  Automating their microbial detection can help these companies in several areas.  First, the shortened time to result can eliminate the need to keep excessive safety stock, and to hold product for extended periods.  The automated nature of the detection can eliminate the need for individuals to manually read and record the colony forming units (CFU’s), an activity open to human error.  Finally, the ability to have a system provide real-time alerts and LIMS integration provides the opportunity for increased responsiveness and remote analysis

A few of the executives I spoke with at these conferences saw the value of automated rapid microbial detection, but were struggling to articulate that benefit to upper management.  This appears to be a common issue, and we recently wrote a whitepaper on the subject that can help companies build their business case. 

Hearing from these executives first hand energizes me about the opportunities for Rapid Micro Biosystems and our automated rapid microbial detection technology. 

For those of you heading to Orlando next week for the ISPE annual meeting, please stop by booth #200 to introduce yourself.  I’d love to meet you.

Julie Sperry
Chief Commercial Officer
Rapid Micro Biosystems