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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