There has been a gradual increase in the use of rapid microbiological methods within the drug industry, “but there has not been this mass exodus” to rapid micro that you might expect, said Michael J. Miller, PhD, President of Microbiology Consultants, Inc., at PDA 2010 in Orlando. Miller, a former Eli Lilly senior research fellow, has been a pied piper in urging the industry to modernize its means of environmental monitoring and in-process product testing.
Even though publications, speakers, and regulators have been advocating for it, industry has been slow to adopt RMM’s. When Miller asked his audience at PDA how many of them were using RMM’s, only a handful of listeners raised their hands. There must be a reason for this hesitancy, he stated.
It has to do with establishing a business case for adopting rapid methods, he said, echoing sentiments that he has expressed for the past few years. “It is absolutely important to establish a return on investment for rapid microbiology as compared to conventional microbiology,” he said. “Rapid methodologies will provide the results a lot faster than conventional methods, often with increased accuracy and consistency.”
Conventional methods “are not sustainable,” he continued. “We need to change . . . we need to be leaner, more agile.”
This is where rapid methods come into play, and the encouragement is there. The 2004 cGMPs from FDA stresses that manufacturers should move towards real-time quality assurance. The PAT initiative also encourages manufacturers to move towards real-time product release testing. FDA’s aseptic processing guidance also encourages rapid methods for environmental monitoring, in-process control testing, and finished-product release.
It’s tough to implement new technologies, he acknowledged, and the costs can be siginificant. “It’s easier said than done,” he agreed. “But it’s not fair to just look at those up-front costs,” said Miller.
Some strategies that Miller suggests for assessing RMM’s:
- Review your current conventional methodology and look at opportunities for using rapid microbiological methods.
- Recognize RMM business opportunities. You can reduce testing time and cost, and possibly headcount. You can reduce the number of off-line assays, make immediate decisions on in-process materials, and more. “These are all very good business opportunities,” Miller said.
How can one develop a business case?
- Assess the costs associated with you conventional microbiological method, including the cost per test, the testing and data sampling hours expended, and the estimated cost of employee hours per test. These are just a few of the factors to consider, Miller noted.
- Assess the cost associated with your rapid method. This includes the initial investment in capital costs, operator training, and validation and qualification. Additional regulatory filings may be required in this step.
- Look at the cost savings/avoidances associated with RMM, including reduced testing, reduced time, reduced headcount, and possibly reduced downtime.
- Assemble financial models. There are a number of models that can be used, said Miller: Return on Investment, Payback Period, Net Asset Value, and more.
According to Miller’s own case studies, payback period for upgrading to rapid methods is approximately six months, depending on the project. There’s a business case to be made for rapid methods, he said. Manufacturers just need to take the time to develop it.