GMP production of oligos for diagnostic use

1st April 2013

Integrated DNA Technologies (IDT), a 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.

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