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.

Free White Paper: Advanced Detection of Mycoplasmas

Free White Paper: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers

Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing.

Learn how real-time PCR analysis is an effective alternative testing method for fast, preliminary mycoplasma detection.

Visit: http://www.microtestlabs.com/mycoplasmapaper/default.asp

Microtest Offers Comprehensive Accelerated Aging Studies for Medical Device Manufacturers

AGAWAM, MASS. – June 16, 2009 –Microtest Laboratories is an industry leader in providing validation studies is now offering accelerated aging studies as part of Microtest’s portfolio of package validation services.

Microtest uses accelerated aging studies to aid medical device manufacturers in predicting what will occur to the packaging or product during normal storage conditions. Studies are used to set preliminary shelf life dates, the period during which the product remains stable for its intended use.

Available accelerated aging studies from Microtest include:

• Standard chamber temperature studies (-70C, -20C, 25C 60% RH), (30C 65%RH), (35C 75% RH), (40C 75%RH), (50C 10-50% RH),( 55C 10-50%RH), (60C 10-50%RH)
• Post-stability/aging testing
• Custom studies
  

Backup storage is guaranteed. All chambers are monitored by SCADA, a 24-hour temperature monitoring system that alerts Microtest personnel to out of tolerance conditions, and feature back-up power.

“Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (http://www.microtestlabs.com/). “And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.”

Microtest is widely recognized for its problem-solving expertise in medical device contract manufacturing. Services include single-source production and testing, plus dedicated product management.

For more information on Microtest’s complete portfolio of services, visit Microtest Laboratories on the Web at www.microtestlabs.com/medical-device-testing/package-validation-testing.html, or call 1-800-631-1680.

Or, visit Microtest at the 2009 MD&M East, June 9th-11st, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

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., www.tizinc.com