Microtest Labs Provides Complete Fill and Finish Manufacturing
Services for Clinical Trial Material
AGAWAM, MASS. – May 3, 2010 – Microtest Laboratories
will highlight its newly
expanded fill and finish manufacturing service for all Phases
of clinical trials at the BIO
International Convention, booth #1944, May 3-6 in Chicago.
Microtest is a leader in providing flexible, customizable aseptic
processing and fill/finish services for all pharmaceutical producers
conducting Phase 1, 2, or 3 clinical trials.
“Virtual companies and smaller pharma manufacturers with
no infrastructure for
manufacture can partner with Microtest to provide their clinical
trail material to clinics in an efficient and timely manner. Large
manufacturers that don’t wish to divert high-capacity production
lines will find Microtest a fast, efficient, cost-effective alternative,”
said Alex Mello, Director of Project Management, Microtest. “Manufacturers
of any size will discover a partner in Microtest with all the
specialized knowledge, experience, and facilities they need.”
Microtest provides the flexibility for all types of pharmaceutical
and biopharmaceutical
manufacturing. Microtest will formulate per the approved batch
record, which may include mixing, agitation, heating/cooling,
etc. Microtest can provide problem solving experience to any of
the specifics of a manufacturer’s process. Post formulation,
Microtest’s analytical capabilities allow for a full spectrum
of available in-process tests to ensure that the drug product
is formulated to the strict specifications set by the manufacturer.
Post in-process testing, filtration occurs utilizing the manufacturer’s
specified filtration system, redundant as applicable. The product
is filled into the designated vial type/size specified by the
manufacturer as well as stoppered and capped using the manufacturer
defined container closure system. Product is filled, capped and
sealed under an ISO Class 5 environmental area.
Post fill, the product undergoes full 100% manual visual inspection,
which is quality-
controlled post-inspection by a qualified operator by performing
an AQL inspection. Product is labeled per approved labels and
stored in Microtest’s fully validated material control department
at a multitude of storage conditions.
“As Microtest is a leader in testing of pharmaceutical drug
products, we offer the full release package on-site thereby ensuring
the most expeditious release of the product,” Mello said.
“The specification documents allow for maximum efficiency
when the samples are taken and released to our QC laboratories
– both QC Microbiology and QC Analytical. Our representatives
can discuss the testing on any final drug product specification
and determine the most efficient release strategy.”
Microtest fill/finish operations comply with both U.S. FDA and
European EMEA guidelines. Microtest has been inspected by the
U.S. FDA, U.S. DEA, and qualified persons for both the manufacture
and release testing of final drug product.
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/aseptic-processing/fill-finish/
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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