Integrated DNA Technologies (IDT), the
world leader in oligonucleotide synthesis, has extended its proven expertise in
oligo research, development and production to clinical and commercial OEM
customers. Its Clinical and Commercial Manufacturing (CCM) facility is
dedicated to the GMP production of oligos for diagnostic use. With the need for
fully compliant oligos in the clinical sector, the production facility is fully
ISO 13485:2003 certified, and registered with the US Food and Drug
Administration (FDA).
IDT's CCM facility manufactures oligos to meet any defined
specifications, and customers are able to maintain total control over the
entire process. With guaranteed stability and lot retention, CCM oligos are
manufactured in a dedicated cleanroom facility to eliminate the potential for any
contamination, and each oligo order undergoes strict QC and HPLC purification.
The CCM suite is also a contract manufacturer of
in vitro diagnostic
devices (IVDs), analyte-specific reagents (ASRs) and nucleic acid testing
(NAT).
With flexible, user-defined ordering methods, the complete process
is easily managed and tailored to meet each individual need. A dedicated IDT
customer manager acts as a single point of contact, providing clinical and
commercial manufacturing clients with the highest level of customer service.
For more information on IDT's CCM
offering, please visit
www.idtdna.com.
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