Navigation Links
White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes
Date:3/19/2008

AGAWAM, Mass., March 19 /PRNewswire/ -- For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.

The informative white paper, "Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistakes," focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper.

In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights -- and their remedies -- are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations for Microtest Laboratories. Dobiecki's experience, which spans 25 years in the manufacturing and quality control of pharmaceuticals, medical devices, and biologic products, includes the preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections (PAI), as well as multiple U.S. and European Regulatory Inspections.

In the white paper, Dobiecki:

-- Details the nine key components of the RFP -- The First Step (in the

selection process)

-- Discusses the finer points of Evaluating the Contractor's Proposal

-- Explains the two types of Site Visits and what should be included on

the agenda

-- Provides cautionary tips for making The Selection itself

-- Warns of stumbling into making The Biggest Mistake which can derail a

successful selection at any step of the process.

To download the white paper, free of charge, visit: http://www.microtestlabs.com/asepticpaper.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical and biotechnology industries. Based in Agawam, Massachusetts, USA, 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. Steve Richter, Ph.D. http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. White Paper Details Environmental Health & Safety Compliance Strategies for Laboratories
2. Marteks lifesDHA(TM) Now Featured in Two New Flavors of Rachels(R) Wickedly Delicious Yogurt from WhiteWave Foods
3. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
4. White Paper Details Infection Control Challenges Hospitals Must Address During Construction
5. Free White Paper Available for Clinical Laboratory Managers: Effectively Isolating Anaerobic Bacteria
6. Free White Paper Helps Biotech Laboratories Maintain a High Level of Infection Control
7. Medco Chooses AllPoints at Anson in Whitestown, Indiana as Site for the Worlds Largest, Most-Advanced Automated Pharmacy
8. Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
9. Microtest Offers Free White Paper: Virus Testing for Biological Products: Partnering With a Contract Lab
10. New White Paper Details Six Steps to Investigate and Prevent Laboratory Accidents
11. Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... - FACIT has announced the creation of a ... Propellon Therapeutics Inc. ("Propellon" or "the Company"), to ... of first-in-class WDR5 inhibitors for the treatment of ... an exciting class of therapies, possessing the potential ... patients. Substantial advances have been achieved with the ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
(Date:6/23/2016)... FRANCISCO , June 23, 2016   EpiBiome ... has secured $1 million in debt financing from Silicon ... ramp up automation and to advance its drug development ... its new facility. "SVB has been an ... beyond the services a traditional bank would provide," said ...
(Date:6/23/2016)... NC (PRWEB) , ... June 23, 2016 , ... In ... University Hospital in Denmark detail how a patient who developed lymphedema after being treated ... tissue. The results could change the paradigm for dealing with this debilitating, frequent side ...
Breaking Biology Technology:
(Date:6/1/2016)... 1, 2016 Favorable Government Initiatives ... and Criminal Identification to Boost Global Biometrics System Market ... TechSci Research report, " Global Biometrics Market By ... and Opportunities, 2011 - 2021", the global biometrics market ... on account of growing security concerns across various end ...
(Date:5/12/2016)... 2016 WearablesResearch.com , a brand of ... results from the Q1 wave of its quarterly wearables ... consumers, receptivity to a program where they would receive ... insurance company. "We were surprised to see ... Michael LaColla , CEO of Troubadour Research, "primarily because ...
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted ... quarter of 2015 The gross margin was 49% (27) ... the operating margin was 40% (-13) Earnings per share ... operations was SEK 249.9 M (21.2) , Outlook   ... M. The operating margin for 2016 is estimated to ...
Breaking Biology News(10 mins):