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Posts Tagged ‘BIO International Convention’


Friday, April 30th, 2010

“Information Transfer for Early Stage Fill/Finish Clinical Trial Material” Presentation is Featured at BIO International Convention

microtest-logo1

AGAWAM, MASS. – May 3, 2010 – Alexander Mello, Director of Project Management at Microtest Laboratories, Inc. will present “Information Transfer for Early Stage Fill/Finish Clinical Trial Material” at the BIO International Convention, May 5, 2010 in Chicago.

Outsourcing fill/finish on an early stage/new clinical trial material has many challenges. The presentation will outline early stage clinical trial product information/technical transfer and detail out the challenges in educating the Contract Manufacturing Organization (CMO) about the nuances and special treatments for your product. Mello will discuss the issues involved with new large molecule products and product specifications that need to be discussed prior to subcontracting manufacturing to the CMO, including namely fill/finish, final release testing, storage and shipping.

Topics will include:
• Initial discussions on product nuances and specifications
• Material handling
• Temperature control before, during and after the manufacturing process
• In-Process controls (testing and other process requirements)
• Fill/Finish restraints (shear, bruising, foaming etc)
• Inspection
• Release Testing
• Storage/Shipping

Alexander Mello is Director of Project Management for Microtest, a leader in pharmaceutical testing services. He has 18 years of experience spanning Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

The presentation, “Information Transfer for Early Stage Fill/Finish Clinical Trial Material,” is scheduled for May 5th, 2010, 2-2:30pm at Booth 3338. The presentation is sponsored by Genetic Engineering News.

For more information, visit Microtest at the BIO International Convention, booth #1944, May 3-6 in Chicago. Or, visit the Microtest website at: http://www.microtestlabs.com/pharmaceutical-testing-services/ or call 1-800-631-1680.

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.

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Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations

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Tuesday, May 1st, 2007

Microtest to Highlight Virology and Pharmaceutical Testing, Contract Manufacturing Capabilities at Bio International Convention

AGAWAM, MASS. – May 1, 2007 – Microtest Laboratories (http://www.microtestlabs.com/) will highlight its expanded contract manufacturing, virology, and pharmaceutical testing capabilities at the BIO International Convention, May 6-9 at the Boston Convention & Exhibition Center.

With its completion of a $7.5 million capital improvement program, Microtest has added a new state-of-the-art pharmaceutical testing laboratory, a series of segregated virology testing laboratories, new aseptic fill/finish manufacturing facilities, and purchased a MicroSeq® Microbial Identification System – along with the hiring of additional professional staff.

With this addition, Microtest has bolstered its services and emerged as a leader in the contract manufacturing market.

“As a customer-focused provider of both contract laboratory testing and contract manufacturing services, we offer unique cross-over benefits for our customers,” said Steve Richter, PH. D., Microtest President. “These include a complete range of pharmaceutical and virology test services that can support full in-process and product release testing as well as product stability testing, raw material qualification, and assay development/validation,” added Richter.

“Moreover, since we manufacture the pharmaceutical product – as a growing provider of fill/finish operations –we have all the systems and procedures in place to fully support all the requirements of the FDA, EMEA and any drug-regulating body in the world,” Richter noted.

For more information on Microtest capabilities and services, visit Richter in the Microtest booth, number 533/A20, at the BIO International Convention, May 6-9 in the Boston Convention & Exhibition Center in Boston.

Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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.

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Press release contact: Tizinani Whitmyre, www.tizinc.com

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