Integrated DNA Technologies' Clinical & Commercial Manufacturing

IDT's Clinical and Commercial Manufacturing (CCM) suite is a "facility within a facility" dedicated to the GMP manufacture of oligonucleotides for diagnostic use. The CCM suite services customers who need defined product specifications or require control over manufacturing processes. CCM suite products parallel IDT's proven research line which simplifies the transition of oligos and other products from research to clinical applications.

The CCM suite is ISO 13485:2003 certified, registered with the US Food & Drug Administration (FDA), and is a contract manufacturer for in vitro diagnostic devices (IVDs), analyte-specific reagents (ASRs) and nucleic acid tests (NATs). CCM services include dedicated ordering, production, final-fill, and shipping systems that meet the elevated quality standards required for products in clinical or commercial applications.

Primary benefits include:

1. GMP oligo manufacturing minimizes your regulatory and vendor auditing burdens.
2. Transparent, customer-defined and controlled manufacturing process
3. Flexible, customer defined ordering methods
4. Customer relationship managed by a single point of contact.
5. Long-term pricing stability through supply agreements

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