Microtest Expands Contract Parenteral Manufacturing Services With $7.5 Million Investment

AGAWAM, MASS. – October 21, 2006 – Microtest has dramatically expanded its contract parenteral manufacturing services with a $7.5 million capital improvement program underway at its Agawam, Mass. headquarters facilities and laboratories.

“With the investment – in laboratories, people, and technology – we’ve dramatically expanded our aseptic processing and support and doubled the size of our facilities,” said Microtest President Steven Richter. “Coupled with our 15-years of experience in medical device testing, we’ve created a single-source manufacturing solution for pharmaceutical manufacturers.

“We can deliver fill-finish services integrated with stability and testing services for a complete solution that lowers cost, improves quality, and compresses time to revenue,” he said. “The result is immediate project start-up, a single technology transfer, easier regulatory submissions, and accelerated time to clinical trials.”

Microtest will feature details of its expanded contract parenteral manufacturing services during the 2006 AAPS Annual Meeting and Exposition, Oct. 29 to Nov. 2, 2006 in San Antonio, TX, at exhibit booth number 891.

Microtests’s expanded contract manufacturing facilities feature:
• Dedicated Aseptic Processing Suites
o ISO 7 Glassware Preparation Area
o ISO 7 Formulation Room
o ISO 6 Fill Line Room with a fill line in a self-contained ISO 5 enclosure
o Lot sizes from <500 to 20,000 vials
o Fill volumes 0.5 ml to 30ml
• Dedicated Manufacturing Staff & Project Management
• In-Process and Release Testing of Final Drug Product
• Automated Labeling
• Aqueous and Oil based Product Handling
• Approved to Handle DEA Regulated Drug Products
• FDA and DEA Registered and Inspected Facilities
• QP Audited Facilities

The company’s facilities are designed for multi-product operations, which include FDA regulated biologics, drugs, and devices. Products range from Phase I clinical trial material to commercially available offerings. Microtest offers manufacturing solutions for vaccines, small molecules, biopharmaceuticals and Oligonucleotides.

Microtests’s improved capabilities include:
o Technology transfer
o Method transfer/qualification/validation
o Process flow determination
o Raw material specification/development/testing
o In-process development treatment
o Formulation (aqueous and organic)
o Vial filling, stoppering, and crimp capping
o Vial inspection
o Vial labeling
o Final product release testing
o ICH compliant stability programs
o Timely batch record reconciliation and review

Richter said Microtest provides a “highly flexible approach” that “enables single-source production and assures seamless integration” with a manufacturer’s processes and philosophy.

Microtest performs all method and technology transfer activities under an engineering run in a formalized system. The company’s method transfer qualification and validation activities can include any or all of the following: microbiology, virology, vial integrity, biologics analytical testing, and pharmaceutical analytical testing.

“Our process ensures we meet all government contract requirements and will accelerate a manufacturer’s time to clinical trials,” Richter said.

For more information, visit Microtest in booth number 891 at the 2006 AAPS Annual Meeting and Exposition, Oct. 29 to Nov. 2, 2006, or contact Microtest on the Web at www.microtestlabs.com, or toll-free at: 1-800-631-1680.

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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.