BioLumix met with FDA’s Center for Drug Evaluation and Research (CDER) personnel to present its new technology, answer questions and demonstrate how the BioLumix rapid, automated microbiology can be used in the Pharmaceutical industry. The technology was warmly received by the CDER and BioLumix is encouraged by its ability to submit a Drug Master File (DMF). This will help to simplify and speed up the regulatory review process for companies adopting its technology.
The DMF is a technical document that contains support data for specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology. The DMF can be used to streamline the validation of the BioLumix system, saving companies that wish to adopt the technology time and money. For over the counter drugs the documents can serve as the basis for the validation package.
FDA’s Support and Encouragement of New Technologies
Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER stated that “FDA actively encourages use of new technologies including rapid microbiology methods” (RMM). During the 2007 PDA 2nd Annual Global Conference on Pharmaceutical Microbiology, Dr. Brenda Uratani, consumer safety officer for the CDER, described the benefits of using rapid methods in microbiology. Drs. David Hussong and Robert Mello (New Drug Microbiology Staff at CDER) published a paper and stated the following: “New microbiology methods can offer advantages of speed and precision for solving microbiological problems associated with materials or environmental influences. Neither Corporate economics nor regulatory attitudes should be a barrier to the use of new testing technologies or different measurement parameters. In fact, if we are to increase our understanding of quality-based products and processes, then quality by design principles and risk analysis methods must be extended to the development of new microbiological technologies. This approach will drive process engineering to yield real, measurable gains in microbiological product quality assurance.”
Dr. Bryan Riley, New Drug Microbiology Staff at CDER, published a paper describing the opportunities for RMM’s within the pharmaceutical industry, “The use of rapid microbiology methods by the pharmaceutical industry should offer many advantages. Receiving microbiology test results sooner will provide for better control and understanding of the manufacturing process via faster feedback”. He continued stating that “There are many exciting potential uses for rapid microbiology methods in the pharmaceutical manufacturing process, and industry should not feel that FDA will be a hindrance to the appropriate use of these methods.”
Why New Rapid Automated Methods Are Desired?
Newer microbiological methods can improve company’s quality of testing and result in significant financial savings. Such methods can reduce cycle times resulting in a leaner and more responsive supply chain. At every point where microbial testing is done (raw materials, work-in-progress, or finished products) batches may be held in quarantine for up to seven days before they are pronounced ready to move to the next stage. Waiting for microbial results can tie up working capital and results in storage expenses and a delay in supplying products to the market. The faster results can identify a contamination and enable implementation of corrective action, and cost savings. Consequently, an increasing number of pharmaceutical companies are becoming interested in adopting RMM’s. By utilizing rapid methods for microbiology, manufacturers can dramatically slash the amount of time products must be held for microbiology testing and drive new efficiencies with less capital tied up in finished goods inventory, and reduced warehouse space requirements.