Associates of Cape Cod’s CTS was one of the first laboratories established
specifically for endotoxin testing by the LAL method. Today, more than 25
years later, CTS is still the world leader for experience, service, and
quality. CTS has a long history of solving problems for clients; CTS creates
testing solutions that meet regulatory requirements. Technical Skills, Quality,
Service, and Speed are keys to CTS reputation as the premier laboratory
for Endotoxin and Glucan testing.
PRODUCT TESTING
Testing for endotoxin is performed at many steps in the manufacture of
drugs and medical devices. Endotoxin testing is required for the release
of finished product (see Validation of End Product and Release Testing).
Testing for endotoxins is also frequently performed to assess raw materials,
in-process materials, vendors, as well as projects and components in Research
and Development. Endotoxin testing is often a component of investigations
into product quality issues.
CTS works with clients to perform testing rapidly. CTS assists quality
departments in identifying endotoxin sources, and troubleshooting product
and production issues. CTS can help with integrating endotoxin testing
into the quality system at the client's company.
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RAW MATERIALS TESTING
Raw materials can be tested as part of a traditional QC program or Process
Analytical Technology (PAT). Identifying the amount of endotoxin in raw
materials helps recognize process modifications that can improve the final
product. Matching results from raw materials and final product can yield
the contribution of each raw material to the endotoxin content of the
final product and document improvements in quality during production.
Some raw materials should have endotoxin limits established and confirmed
to determine if a batch can be accepted from a vendor.
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VALIDATION OF END-PRODUCT
Three production lots of the final product must undergo the Inhibition/Enhancement
(validation) assay before the Limits Test may be used to release final
product. The validation assay is also used in QC programs to accept raw
materials into production. Validation testing is performed in accordance
with USP, EP, and/or JP, depending on the specifications of the client.
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RELEASE TESTING
The Release Test is also known as the Limits Test. It is used to release
finished product for use in humans and animals and for raw/in-process
materials. Release testing is performed in accordance with USP, EP, and/or
JP, depending on the specifications of the client.
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METHODS DEVELOPMENT
Increasingly, new biotechnology drugs and new materials used to make devices
require specials approaches to testing. Among the advantages of LAL testing
are the sensitivity, ease of performance, and the fact that it is a worldwide
compendial method. Many samples must be treated to allow use of the compendial
method. CTS works with clients to develop methods to test drugs so they
comply with current regulatory requirements. As the oldest contract test
lab in the endotoxin business, CTS has vast experience working with new
materials, difficult samples, and other testing problems facing clients.
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METHODS TRANSFER
Many companies have sufficient testing volume to justify performing the
assay in-house. For these customers, Associates of Cape Cod supplies a
complete line of the highest quality LAL reagents. CTS supports this line
by working with companies to develop and optimize methods to test products.
CTS also helps customers convert from one methodology to another, e.g.,
from testing by the gel-clot method to chromogenic or turbidimetric assays.
The methods developed by CTS are then transferred to the client for use
by their own QC laboratories. Your company gets the assurance that the
method will work.
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ARCHIVING
CTS will archive reports for clients if requested. Our standard document
retention is seven (7) years. Validation reports are kept beyond seven
years for at least two years past the withdrawal of the product. Characterization
and Release assays will be archived beyond seven years if requested.
For information and quotes, please call CTS at 508-540-3444 x2281 or
e-mail testservice@acciusa.com.
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SENDING SAMPLES
Download the Sample
Submission Form (114K PDF) and complete the form. This form must be
submitted with all samples. This form requires Adobe Acrobat Reader be
installed on the viewer's computer. To download a free copy of Acrobat
Reader click here to
be taken to the Adobe website.
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