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

AGAWAM, MASS. – April 20, 2010 – 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. The typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical are discussed in a new, free, white paper.

The new white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” will be available from Microtest Labs at Interphex 2010, booth #147, April 20-22, 2010, in New York City.

The new white paper is also available for free download at: http://www.microtestlabs.com/control-environment.

The white paper focuses on 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”).

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.

The white paper is authored by Alex Mello, Director of Project Management, Manufacturing, of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services. In the white paper, he:

• Warns to test only when necessary to reduce interventions.
• Explains to test using methods that give data as quick as fittingly possible to condense processing times.
• Discusses 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.

For a copy of the free white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit Microtest Laboratories at Interphex 2010, booth #147, April 20-22, 2010 in New York City.

Or, visit the Microtest website at: http://www.microtestlabs.com/control-environment. 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.