Navigation Links
Celsis Rapid Detection's Updated Drug Master Files (DMFs) Accepted by FDA

CHICAGO, May 27 /PRNewswire/ -- Celsis International, the global leader in rapid microbial detection, announced it has recently updated its Drug Master Files with the U.S. Food & Drug Administration (FDA) to include information on testing both non-sterile and sterile raw materials, in-process solutions and finished goods on the Celsis system.

"A growing number of our Rapid Detection customers are using their Celsis systems to confirm sterility," said Judy Madden, Vice President of Celsis International. "By updating and expanding the information available in our DMFs regarding micro limits and sterility testing, we are helping to simplify and, ideally, speed the regulatory review process," she explained.

Celsis offers a variety of resources to help customers with their filings, including the assistance of an experienced regulatory compliance manager. "We understand the economic value to our customers in getting their products to market faster," said Madden. "Companies won't realize the full financial benefits of rapid detection unless their systems are successfully validated. For this reason we have always delivered outstanding global scientific, technical and customer support as an integral and important part of every Celsis system."

The FDA accepts DMFs from suppliers like Celsis that can be referenced by pharmaceutical companies submitting new, supplemental or amended drug applications. The DMF is a technical document that contains reference support data as well as proprietary information about manufacturing and formulation.  Celsis has two DMFs, the originals dating back to 2006, for the RapiScreen™ and AKuScreen™ assay families. The newly updated DMFs include data for specificity, limit of detection, robustness, ruggedness and equivalence, for use with both microbial limits and sterility testing. They can be used to supplement or streamline the validation of a Celsis system, saving companies' time in preparation and saving the FDA time in review and approval.

For more information, contact Celsis Rapid Detection at +1 312 476 1282 or visit

About Celsis International

Celsis International is a leading global provider of innovative life science products and laboratory services to the pharmaceutical and consumer products industries. Each Celsis division delivers substantial time and cost savings to its customers while ensuring product quality and safety for consumers. Celsis' extensive client base includes leading pharmaceutical and consumer products companies, as well as all of the top 25 pharmaceutical companies worldwide. Visit for more information.

SOURCE Celsis International
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Celsis Receives Frost & Sullivan 2008 Best Practices Award
2. Celsis Launches RapiScreen(TM) Beverage Microbial Screening System
3. Celsis In Vitro Technologies and Promega to Offer Fast, Reliable Solutions for ADME-Tox Testing With Primary Hepatocytes
4. Celsis Introduces ReACT(TM) RNA-Based Microbial Detection Assays
5. Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes
6. Chicago-Based Celsis International Goes Private
7. Celsis IVT Granted U.S. Patent for LiverPool(TM) Hepatocytes
8. Celsis IVT Settles LiverPool Patent Infringement Suit With XenoTech, LLC
9. Pathway Medical Technologies Adds Joe Rafferty as VP, Sales, and Moves To Larger Facility to Accommodate Rapid Growth
10. NanoLogix Inc. Appoints Director of IP and Makes Progress on Rapid Anthrax Detection
11. Spectral partner launches EAA(TM) Rapid Sepsis Diagnostic in Germany
Post Your Comments:
(Date:11/25/2015)... 25, 2015 The Global ... a professional and in-depth study on the current ... (Logo: ) , The ... including definitions, classifications, applications and industry chain structure. ... international markets including development trends, competitive landscape analysis, ...
(Date:11/24/2015)... N.J. (PRWEB) , ... November 24, 2015 , ... The ... the recipient of the 2016 USGA Green Section Award. Presented annually since 1961, the ... through his or her work with turfgrass. , Clarke, of Iselin, N.J., ...
(Date:11/24/2015)... VANCOUVER , Nov. 24, 2015 /CNW/ - iCo ... ICOTF), today reported financial results for the quarter ... are expressed in Canadian dollars and presented under ... the United States ," said Andrew ... "These advancements regarding iCo-008 are not only value ...
(Date:11/24/2015)... - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ) (the "Company"), ... Toronto Stock Exchange, confirms that as of the date ... that would cause the recent movements in the Company,s ... About Aeterna Zentaris Inc. . ... Zentaris is a specialty biopharmaceutical company engaged in developing ...
Breaking Biology Technology:
(Date:10/29/2015)... Oct. 29, 2015  The J. Craig Venter Institute ... "DNA Synthesis and Biosecurity: Lessons Learned and Options for ... Health and Human Services guidance for synthetic biology providers ... --> --> Synthetic ... the potential to pose unique biosecurity threats. It now ...
(Date:10/29/2015)... Oct. 29, 2015 Today, LifeBEAM ... partnership with 2XU, a global leader in technical ... smart hat with advanced bio-sensing technology. The hat ... to monitor key biometrics to improve overall training ... the two companies will bring together the most advanced ...
(Date:10/26/2015)... and LAS VEGAS , Oct. ... Labs , an innovator in modern authentication and a ... announced the launch of its latest version of the ... enabling organizations to use standards-based authentication that supports existing ... S3 Authentication Suite is ideal for organizations deploying customer-facing ...
Breaking Biology News(10 mins):