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