Navigation Links
Celsis Rapid Detection's Updated Drug Master Files (DMFs) Accepted by FDA
Date:5/27/2010

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 equ
'/>"/>

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

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... Baylor Research Institute (BRI) at Dallas ... in Phoenix, AZ , today announce ... treatments for patients with a broad range of cancers. Aligning ... clinical trials and access to technology to drive the development ... bedside across Baylor Scott & White Health,s 49 ...
(Date:5/21/2015)... YORK , May 21, 2015  Susan ... Research (FPWR), a nonprofit organization dedicated to supporting ... Prader-Willi syndrome (PWS), announced today that FPWR has ... and Irina Shaulov contributed $1 million ... clinical initiatives.  ...
(Date:5/21/2015)... May 21, 2015 Imagine being ... - and those of others. Being able to read ... and read people to anticipate their thoughts and actions ... emotions and feelings to create unique abstract paintings and ... games. Get inside a first-person-shooter as it creates action, ...
(Date:5/21/2015)... (PRWEB) May 21, 2015 As part ... Medical Center (BDWMC), Sun Health Foundation funded a $3.25 ... new inpatient pharmacy with the most up-to-date features and ... June 2. The pharmacy's 45 staff members will begin ... 4,895-square-foot space in the coming days. , The ...
Breaking Biology Technology:Precision Medicine Collaboration to Increase Options for Cancer Patients 2Precision Medicine Collaboration to Increase Options for Cancer Patients 3Precision Medicine Collaboration to Increase Options for Cancer Patients 4The Foundation for Prader-Willi Research Receives $1M Contribution in Support of Clinical Initiatives 25 Days to Meet ARGUS - The World's First Contactless Emotions Scanner 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 3
... , ALISO VIEJO, Calif., Sept. 1 ... become an Agilent Certified Service Provider on the Agilent microarray ... (aCGH) which is an application used by researchers to discover ... , (Logo: http://www.newscom.com/cgi-bin/prnh/20090428/LA06744LOGO ) , ...
... , FRAMINGHAM, Mass. and SYDNEY, ... ) (ASX: HIN) today confirmed that trading of its CHESS ... temporarily suspended for the reasons stated below. In consequence, ... temporarily suspended. Based on discussions with representatives of NASDAQ ...
... AMSTERDAM, September 1 SynCo Bio Partners ... biopharmaceuticals,announced today that it has expanded its business into ... to manufacture a live biotherapeutic,for an emerging Japanese pharmaceutical ... product is an innovative live biotherapeutic,based anticancer drug. The ...
Cached Biology Technology:Ambry Genetics Announces Certified Service Provider Status for Agilent Microarrays 2HeartWare International, Inc. Temporary Suspension of Trading 2HeartWare International, Inc. Temporary Suspension of Trading 3SynCo Bio Partners Enters the Japanese Market as it Signs its First Agreement With a Japanese Pharmaceutical Company 2
(Date:5/20/2015)... May 20, 2015 NXT-ID, Inc. (NASDAQ: ... wholly owned subsidiary, 3D-ID LLC, a company engaged in ... for the biometrics technology portion of the recently awarded ... the Department of the Army. 3D-ID LLC ... for government, law enforcement and security agencies. ...
(Date:5/14/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/5whpxg/fingerprint ... Sensors Market in Smart Mobile Devices " report ... 2014 was a watershed year for fingerprint sensors in ... Pay,. Apple gave fingerprint sensors a raison d,etre in ... sensors are a must-have feature in flagship smartphones. ...
(Date:5/10/2015)... , May 11, 2015 Fingerprint Cards ... FPC1025 and FPC1155 from the distributor World Peace Industrial Group ... distributors in Asia . Deliveries are planned ... be used by smartphone manufacturers in China ... the communicated revenue guidance of + 1 000 MSEK for 2015. ...
Breaking Biology News(10 mins):NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 2NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 3Global Smart Mobile Devices Fingerprint Sensors Market 2015-2019: Key Vendors are Authentec, Validity Sensors, Fingerprint Cards, Next Biometrics Group. IDEX, and Qualcomm 2Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 235 Million 2
... eat affect the intensity of its taste? It depends on ... Pickering and colleagues from Brock University in Canada. Their work ... have an effect on the intensity of sour, bitter and ... is published online in Springer,s Chemosensory Perception journal. ...
... Journalists may now apply for press accreditation ... (ACS) 244 th National Meeting & Exposition, Aug. ... described national meetings of ACS ― the world,s largest ... because of the scope and importance of the scientific ...
... Julian Hiscox and Dr John Barr of the University,s Faculty ... Porton (HPA) to build a bank of molecular signatures that ... changes seen in cells. Currently the team is barcoding different ... - a virus associated with the onset of asthma in ...
Cached Biology News:To get the full flavor, you need the right temperature 2Virus 'barcodes' offer rapid detection of mutated strains 2
The PxE Thermal Cycler (PxE) is a licensed 96 well PCR machine, developed to provide all fundamental features for value for money thermal cycling....
... The Px2 Thermal Cycler is Thermo Electron's ... to date with easy to use sophisticated ... for easy programming. Designed to offer performance, ... Px2 incorporates a number of customer driven ...
For testing the AQUA technique on your MS instruments....
The Lambda Control Kit contains lambda DNA and two 25mer primers, which can be used to amplify a 500bp fragment. The lambda DNA is purified by CsCl gradient centrifugation and organic extraction foll...
Biology Products: