New Facility Offers Increased Capacity, Additional Quality Systems
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SAN DIEGO, Calif. – February 10, 2004 - Pharmatek Laboratories, Inc. today announced
the completion of its new state of the art cGMP stability storage and testing capabilities. The
company has added additional storage capacity including standard storage conditions,
meeting ICH guidelines, as well as a range of other environmental conditions required for
specialty products.
This expanded service offering follows the Company's move in August of 2003 to a new
pharmaceutical chemistry development laboratory located in the heart of San Diego's
biopharma region. Pharmatek's expanded stability storage includes multiple new chambers
covering a broad range of storage conditions.
Pharmatek performs release and stability testing for all types of drug products, from small
molecule drugs to biomolecules to drug-coated medical devices. Analytical services include:
long-term stability testing, accelerated stability testing, comparative stability testing, forced
degradation studies and stability testing of Active Pharmaceutical Ingredient (API) and
Clinical Trial Material (CTM) to support clinical trials, IND, NDA and aNDA applications.
"Our scientists have years of experience performing all types of analytical testing on a wide
range of drug substances and drug products. We have made a significant investment to
increase capacity and put additional quality systems in place to provide this service on a
much larger scale," explained Tim Scott, President and COO of Pharmatek. There has long
been a shortage of high quality cGMP storage services, particularly on the West coast," added
Scott, "pharmaceutical and biotech companies in Southern California, the Bay Area, Seattle,
British Columbia and elsewhere in the West like to have high quality storage and testing of
their samples in their same time zone."
Each cGMP environmental chamber operates independently, with separate temperature and,
where applicable, humidity controls. All chambers are continuously monitored by a
computerized Tatus Monitoring System. Temperature and humidity setpoint windows are
±2șC and ±5% RH, respectively, with deviations outside setpoint ranges resulting in an
immediate alert to Pharmatek staff.
Additionally, all storage chambers are supported by full generator back up in case of power
failure with a second backup generator if needed. Backup power is fully operational within
6 seconds of power failure.
About Pharmatek Laboratories, Inc.
Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization supporting the pharmaceutical and biotechnology industries. Pharmatek focuses on bringing client compounds from discovery to the clinic with services that include compound selection, analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing.
Company Contact:
Elizabeth Hickman, Marketing Manager
Pharmatek Laboratories, Inc.
(858) 805-6383
ehickman@pharmatek.com
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