11.09.2007 11:30:00
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New Laboratory Information Management Solution From Applied Biosystems Brings Efficiency and Cost Effectiveness to Drug Development and Manufacturing Process
Applied Biosystems (NYSE:ABI), an Applera Corporation business, today
announced a new laboratory information management system (LIMS) that is
expected to help pharmaceutical companies maintain regulatory compliance
and decrease the cost of managing their manufacturing operations. The
SQL*LIMS® Plug and
Play Pharma Package™
solution is a pre-configured and validated LIMS developed specifically
for the pharmaceutical industry that has been shown to reduce up-to 85%
of the cost and as much as 75% of the time associated with deployment1.
Software-based LIMS solutions are used by pharmaceutical companies to
manage their drug development and manufacturing processes. This includes
tracking raw materials and samples as they enter and travel the
laboratory workflow. Maintaining best practices and consistency in these
operations are necessary for complying with regulatory requirements and
ensuring a safe and reliable supply of pharmaceutical products.
The deployment and validation of LIMS software has traditionally been
expensive and time consuming. The validation process alone requires that
a company audit the LIMS system to demonstrate that it adheres to
specific national and international regulations such as operational
procedures, security definitions, and testing methods. As a result,
considerable time and expense are often spent in designing, customizing,
and validating traditional LIMS systems, which can significantly
increase the total cost of the overall solution.
Analysis conducted by Applied Biosystems indicates that a typical LIMS
implementation takes approximately eight months, with most of that time
spent configuring and validating the system. Because SQL*LIMS Plug and
Play Pharma Package is specifically designed and validated for the
pharmaceutical manufacturing industry, Applied Biosystems’
customers have been able to implement the system in as little as two
months.
Kern Pharma, S.L, a pharmaceutical development and manufacturing company
based in Spain is one of the first organizations to implement the
SQL*LIMS Plug and Play Pharma Package. This particular pharmaceutical
company was attracted to the solution’s
out-of-the-box functionality that allows it to be implemented with
minimal reallocation of human resources away from their primary
manufacturing responsibilities.
"What makes SQL*LIMS Plug and Play Pharma
Package unique is that it arrives ready to deploy, with the operational
functionality required for managing the pharmaceutical manufacturing
process,” said Albert Almajano, IT project
manager at Kern Pharma. "We expect that
SQL*LIMS Plug and Play Pharma Package will become an integral part of
our ongoing efforts to improve efficiency and maintain regulatory
compliance in our drug development and manufacturing operations.”
Applied Biosystems designed SQL*LIMS Plug and Play Pharma Package as a
complete solution that integrates critical functions involved in drug
manufacturing operations with the computer hardware and an Oracle
database that enables distribution across an enterprise. The
pre-configured functionality enables system administrators to easily
activate user definitions, security parameters, reporting templates and
testing methods issued by national and international regulatory bodies.
This can help pharmaceutical companies who are upgrading their existing
LIMS as well as those who are new to manufacturing to quickly implement
a validated system that incorporates industry best practices and meets
regulatory requirements.
"Pharmaceutical companies are too often
spending excessive time and money on building and implementing business
solutions that require skill sets or other cost-related resources that
take away from their core business purpose,”
said John Bainbridge, general manager for the LIMS business at Applied
Biosystems. "To help these customers, we’ve
taken everything Applied Biosystems has learned about laboratory
information management systems and have packaged it into a complete
solution that significantly decreases the time and costs associated with
LIMS deployments. This enables pharmaceutical companies to focus on what
they do best, which is developing and manufacturing drugs.”
Applied Biosystems has been a global leader in providing LIMS technology
for more than 25 years. Today, more than 30,000 professionals worldwide
use the company’s SQL*LIMS®
Software in industries as diverse as pharmaceuticals, chemical and
petrochemical manufacturing, environmental science, food and beverage
production, and forensic analysis. For more information, please visit: http://info.appliedbiosystems.com/sqllims.
About Applera Corporation and Applied Biosystems
Applera Corporation consists of two operating groups. The Applied
Biosystems Group serves the life science industry and research community
by developing and marketing instrument-based systems, consumables,
software, and services. Customers use these tools to analyze nucleic
acids (DNA and RNA), small molecules, and proteins to make scientific
discoveries and develop new pharmaceuticals. Applied Biosystems’
products also serve the needs of some markets outside of life science
research, which we refer to as "applied
markets,” such as the fields of: human
identity testing (forensic and paternity testing); biosecurity, which
refers to products needed in response to the threat of biological
terrorism and other malicious, accidental, and natural biological
dangers; and quality and safety testing, for example in food and the
environment. Applied Biosystems is headquartered in Foster City, CA, and
reported sales of approximately $2.1 billion during fiscal 2007. The
Celera Group is primarily a molecular diagnostics business that is using
proprietary genomics and proteomics discovery platforms to identify and
validate novel diagnostic markers, and is developing diagnostic products
based on these markers as well as other known markers. Celera maintains
a strategic alliance with Abbott for the development and
commercialization of molecular, or nucleic acid-based, diagnostic
products, and it is also developing new diagnostic products outside of
this alliance. Through its genomics and proteomics research efforts,
Celera is also discovering and validating therapeutic targets, and it is
seeking strategic partnerships to develop therapeutic products based on
these discovered targets. Information about Applera Corporation,
including reports and other information filed by the company with the
Securities and Exchange Commission, is available at http://www.applera.com,
or by telephoning 800.762.6923. Information about Applied Biosystems is
available at http://www.appliedbiosystems.com.
Applied Biosystems Forward Looking Statements
Certain statements in this press release are forward-looking. These may
be identified by the use of forward-looking words or phrases such as
"should, "planned," and "expect," among others. These forward-looking
statements are based on Applera Corporation's current expectations. The
Private Securities Litigation Reform Act of 1995 provides a "safe
harbor" for such forward-looking statements. In order to comply with the
terms of the safe harbor, Applera Corporation notes that a variety of
factors could cause actual results and experience to differ materially
from the anticipated results or other expectations expressed in such
forward-looking statements. These factors include but are not limited
to: (1) rapidly changing technology and dependence on the development
and customer acceptance of new products; (2) sales dependent on
customers' capital spending policies and government-sponsored research;
and (3) other factors that might be described from time to time in
Applera Corporation's filings with the Securities and Exchange
Commission. All information in this press release is as of the date of
the release, and Applera does not undertake any duty to update this
information, including any forward-looking statements, unless required
by law.
1 The reduction of cost and time estimates are
based on internal Applied Biosystems test results.
Applera, Applied Biosystems, AB (Design), and SQL*LIMS are registered
trademarks of Applera Corporation or its subsidiaries in the US and/or
certain other countries.
©Copyright 2007. Applied Biosystems. All
rights reserved.
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