Celsis hopes for new business from FDA recognition

By Susan Gotensparre

- Last updated on GMT

Related tags Food and drug administration

The US Food and Drug Administration has accepted two Celsis drug
master files (DMFs) that could increase the adoption of its rapid
microbiological detection technology among pharmaceutical

The two DMFs cover microbial screening of pharmaceutical products and were accepted by the FDA within the last four months. They described the use of the firm's Rapid Microbiological Method (RMM), a technology used in its Celsis RapiScreen and AkuScreen products.

Pharmaceutical firms using Celsis RapiScreen or AkuScreen will be able to take advantage of an increased efficiency for regulatory approvals, as the DMF means that the FDA has accepted the technology. Drugmakers can also expect reduction in working capital requirements and shorter manufacturing cycle times, allowing them to meet "just-in-time" manufacturing demands, and improved cash flow from the ability to rapidly detect and deal with contamination issues, according to Celsis.

"Because FDA reviewers can evaluate regulatory filings and simultaneously access additional information about Celsis technology, regulatory submissions are less likely to be delayed due to questions about the technology​," Diane Younker, Celsis global regulatory affairs manager, told In-PharmaTechnologist.com.

The DMFs holds confidential information about the instrumentation, software, reagents and claim support to be referenced by pharmaceutical firms in their regulatory submissions. Celsis said its technology can be used for screening of all pharmaceutical material types, such as raw materials, in-process materials and finished products.

"Pharmaceutical and biopharmaceutical companies understand the benefits of faster product release with rapid microbial methods and are eager to implement rapid technology across a broad product range​, said Younker.

" With the acceptance of two DMFs, including the most recent AkuSCreen, Celsis is demonstrating an ongoing commitment to its customers by helping to streamline implementation​.

The driving force behind Celsis' DMF developments has been to provide their customers with support, allowing them to obtain regulatory approval of submissions quickly and easily.

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