Navigation Links
New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You
Date:8/24/2011

AGAWAM, Mass., Aug. 24, 2011 /PRNewswire/ -- For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, "Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need," explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

"In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it's critical that the selected CMO has comprehensive capabilities that are both in-house and readily available," notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

"Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product," he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

To download the new, free white paper, "Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need," visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello's 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622  


'/>"/>
SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Reportlinker Adds White Biotechnology
2. Reportlinker Adds Future of White Biotechnology in China
3. ACO Proposed Rule Simplified: MedeAnalytics Releases Comprehensive White Paper
4. Scott & White Healthcare President and CEO Alfred B. Knight, M.D. to Retire in 2011, Will Lead Foundation
5. Ingenuity Systems Announces Toxicogenomics Best Practices White Paper
6. PharmAthene Submits White Paper to BARDA for Advanced Development Funding for SparVax(TM) - Novel Recombinant Protective Antigen Anthrax Vaccine
7. UC Riverside graphene specialist Jeanie Lau receives national honor at White House
8. Free Organic Electronics White Paper Discusses Rfid Tags, OLED, AM OLED, PM OLED, Electroluminescence, e-Paper, OE Market Forecast
9. Brown engineering professor wins prestigious White House award
10. PharmSource Releases White Paper on Role of U.S. Foreign Corrupt Practices Act (FCPA) in the Bio/Pharma Industry
11. PhRMA Statement on AARP-White House Press Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... March 22, 2017 The global ... a research report by Transparency Market Research (TMR). The ... Inc., and AbbVie Inc., accounted for a share of ... players in this market are focusing aggressively on mergers, ... which is likely to lead to market consolidation in ...
(Date:3/22/2017)... /PRNewswire/ - FACIT announced a seed stage investment ... start-up created by FACIT focused on developing a ... with non-dilutive capital, achieves a targeted $3.0M financing ... Propellon to accelerate the nomination of a candidate ... entering a strategic partnership for clinical trials in ...
(Date:3/22/2017)... Pa. , March 22, 2017 /PRNewswire/ ... global independent provider of product and service ... today that it has acquired EPL Archives, ... supports customers across the entire regulated product ... archive sample, document storage and ancillary services. ...
(Date:3/22/2017)... ... , ... Okyanos Cell Therapy has announced Tallahassee, FL will be the next ... Cell Therapy: The Next Phase in the Evolution of Medicine.” As the Bahamas’ first ... Therapy Act, Okyanos maintains a mission to help “no-option” patients and those with ...
Breaking Biology Technology:
(Date:3/22/2017)...   Neurotechnology , a provider of high-precision ... the release of the SentiVeillance 6.0 ... recognition using up to 10 surveillance, security and ... new version uses deep neural-network-based facial detection and ... a Graphing Processing Unit (GPU) for enhanced speed. ...
(Date:3/20/2017)... , March 20, 2017 At this year,s ... -based biometrics manufacturer DERMALOG. The Chancellor came to the DERMALOG stand ... is this year,s CeBIT partner country. At the largest German biometrics ... in use: fingerprint, face and iris recognition as well as DERMALOG´s multi-biometrics ... ...
(Date:3/13/2017)... 13, 2017 Future of security: Biometric Face Matching software  ... ... DERMALOGs Face Matching enables to match face pictures against each other ... identify individuals. (PRNewsFoto/Dermalog Identification Systems) ... DERMALOG,s "Face Matching" is the fastest software for biometric Face Matching on the ...
Breaking Biology News(10 mins):