White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

AGAWAM, MASS. – August 12, 2008 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed.

A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). It is available for download at: http://www.microtestlabs.com/control-environment.

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

In the white paper, the authors:

• Warn to test only when necessary to reduce interventions.
• Explain to test using methods that give data as quick as fittingly possible to condense processing times.
• Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Technorati tags: Contract Manufacturing Organization, CMO, aseptic fill/finish manufacturing, contract bulk drug manufacturing

White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes

AGAWAM, MASS. – March 20, 2008 – 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 Mistake,” 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 IND's, NDA/ANDA's, 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, 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.

# # #

Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

bookmark to del.icio.us

Technorati tags: Contract Manufacturing Organization, CMO, aseptic fill/finish manufacturing, contract bulk drug manufacturing