Michael -- I think everyone would agree that micro labs need to move to the future and take advantage of rapid microbiological methods. The benefits associated with faster results are well known. Why do you think that automation of the rapid method is important?
Steve -- The traditional model for pharmaceuticals has been to spend significant time and money to develop a drug, and while the clock counts down on the IP, they drive billions of dollars per year from the protected revenue stream. When the patent expires there is still a nice gentle trail off of revenue. This environment has changed. Today, there is tremendous pressure on the traditional model from all sides, including pricing, competing medicines, payouts, and generics. Over the last decade, big pharma has found religion in terms of lean manufacturing, 6-Sigma and driving efficiencies in manufacturing. Quality Control (QC) lab activities have generally gone un-recognized as a contributor to these efficiency challenges, but that perspective is changing. This is especially true of the microbiology lab where manual methods are slow, error prone, labor intensive and not cost effective. Today we are seeing companies apply lean development and manufacturing principles to the labs. I was recently listening to a webcast where Tom Reynolds of BSM noted that Lean is not just about the elimination of waste but also the elimination of wasteful practices. This is where we find opportunities for automation, and why I think automation of rapid methods is important.
What HPLC brought to the analytical lab can be brought to the micro lab through automated microbiological methods. HPLC replaced manual wet chemistry and multiple process steps, resulting in an improved quality of data management with less error rates and greater reproducibility. Additionally, they are now realizing a single point of data entry automatically from these systems, improved efficiency and enhanced access to data distributed throughout a network. This means greater access to information and more efficient decision making. I see the same opportunities for automation to bring benefits to the micro lab. Pharma can realize faster time to market, reduced manufacturing cycle times and the reduction of a common theme among QC microbiologists: a workload that is tremendous, chaotic, and not all that fun. Automation is about improving the work-life balance, and the micro lab is the next wave of focus. Pharma is starting to understand the benefits of operational improvements in the lab and is being proactive.
More from my conversation with Steve in future posts.