BIOLUMIX DMF ACCEPTED BY FDA

DMF Submission Accelerates Regulatory Approval Process to Use BioLumix Simplified, Rapid, Automated Microbiological System

Ann Arbor, MI: BioLumix today announced that the US Food and Drug Administration (FDA) has accepted a BioLumix Drug Master File (DMF) for the BioLumix Rapid Microbiological System. The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs. The DMF can be referenced by drug manufacturers, reducing the review times. In addition, Over The Counter () products can be tested in conjunction with BioLumix Validation Package. The BioLumix DMF includes the information that the FDA requires to assess alternative microbiological detection systems. It includes information about the technology, its accuracy, specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.

“FDA actively encourages use of new technologies including rapid microbiology methods (RMM)” stated Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER. Dr. Brenda Uratani, consumer safety officer for the CDER, described the benefits of using rapid methods in microbiology during the 2007 PDA 2nd Annual Global Conference on Pharmaceutical Microbiology. Drs. David Hussong and Robert Mello (New Drug Microbiology Staff at CDER) published a paper stating: “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.”

Since the DMF data can be referenced directly as part of FDA submissions, it will allow drug makers to expedite the review process for new drugs, thereby enabling an earlier market launch.

Why New Rapid Automated Methods Are Desired?

Newer microbiological methods can improve a 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.

Why BioLumix?

The BioLumix System is extremely easy to operate, it offering straightforward, streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product release. Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies. Advantages include

• Single-platform testing for all assays
• Real-time communication – early warning of contamination
• 48-hour Automated Certificate of Analysis
• Simplified testing with ready-to-use vials
• Validated for your product – IQ, OQ, PQ
• No product interference
• 21 CFR Part 11–compliant software
• Technology based on traditional media
• Remote-access customer support 24/7/365

Contact us today! We would welcome the opportunity to earn another satisfied customer

We're always available to answer any inquiries regarding the sytstem specifications, installation, validation, performance, benefits and cost savings. If you would like to speak with one of our experienced microbiologists or engineers, please contact us directly:

Phone: +1 734.984.3100 Email: info@mybiolumix.com