A dedicated CCM Customer representative acts as single point of contact within IDT for all of your account management needs.
- Representatives serve as project coordinators to gather and route all necessary information from product development through product consumption.
- Orders are placed directly with the representative and workflow verified with manufacturing for accuracy prior to production.
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- CCM pricing can be quoted per customer-defined unit of measure (e.g., per nanomole, per aliquot, per kit, etc.). This feature eases inventory planning and supply forecasting, provides consistent delivered quantity per lot, and allows order by predefined part number
- In CCM “we will learn to speak your language” to facilitate and improve purchasing and inventory management. Examples of actual customer supplied ordering units of measures: “X tests”, “X reactions”, “X tubes”. CCM quotes pricing and communicates in these units of measure.
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- Pricing is typically fixed for 3-5 years, with static pricing guarantees tied to purchasing forecasts.
- Incentive discounts (purchasing milestone based) are common
- OMRs, Forecasts, Lead Times, and “Quality Agreement” language are all integrated into one, definitive Agreement.
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The Oligo Master Record (OMR) is a comprehensive production plan co-designed by IDT and the customer that governs the manufacture of an oligo, oligos, or a defined oligo family.
- Customers can co-develop and approve the OMR, resulting in a transparent manufacturing process from order entry, to manufacturing, all the way to shipping.
- All personnel involved in the manufacture of CCM oligos receive OMR-specific training and customer-specific end-use or assay awareness training.
- All personnel involved in manufacture of CCM oligos receive OMR specific training, and customer-specific end-use or assay awareness training.
- To view a sample OMR, click on the OMR link in the Documents and Support box above.
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- Our facility is FDA registered (3004613294) and ISO 13485:2003 certified.
- Manufacturing and QA independently verify product compliance prior to product release (double-signed Certificates of Analysis).
- To view a sample Certificate of Analysis, click on the COA link in the Documents and Support box above.
- We provide hardcopy analytical QC documentation as a standard product offering.
- IDT has an open door audit policy.
- Quality agreements/contracts are available.
- Validation programs are available for all equipment and processes.
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All CCM orders are processed in a dedicated suite. IDT provides a transparent manufacturing process to all CCM customers through the co-development and approval of an Oligo Master Record (OMR).
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Benefits of IDT manufacturing:
- Capability to provide 10 nmole to 1 gram final deliverable utilizing dedicated production equipment
- Product stability programs as well as lot retention capability
- Three synthesis platforms to meet all of your scale and modification needs
- Liquid handling robots, plate reading spectrophotometers, and IDT exclusive dry down equipment -- all designed to increase the throughput of your oligos
- Multiple HPLC purification methods, including IE-HPLC and RP-HPLC
- Equipment and Process Validation are transparent to customer
- Validated electronic batch record capability for each Manufacturing Lot (individual syntheses, HPLC fractions, etc.)
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IDT offers a full range of final-fill, labeling and OEM solutions with services including:
| - Customer-specified formulation
- Custom packaging
- OEM and kitting solutions
- Third party labeling
- Plate packaging
- Stability programs available
- Functional QC
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In regulated environments it is often desired, if not required, to also order positive controls.
DNA Controls
IDT offers a number of methods for manufacturing DNA controls. UltramersTM, oligos up to 200 bases can be ordered at GMP grade. For more information, please contact your customer service representative.
RNA Controls
 IDT has teamed up with AmpTec to provide GMP grade reference RNAs for in vitro diagnostics. Selecting RNA as reference standard controls for the entire RT-qPCR workflow, from RNA isolation to reverse
transcription and amplification.
For more information on AmpTec please visit www.amp-tec.com
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Our friendly and professional customer service at IDT is here to handle any questions you may have as you take your product from development to final delivery.
| For questions about the services we offer for molecular diagnostics:-
Email ccminfo@idtdna.com
- Call 800-328-2661
- Email your sales representative
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Email agreements@idtdna.com
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- Sequences [Please indicate if a Confidentiality Disclosure Agreement (CDA) is needed prior to transmitting]
- Modifications (i.e. fluorophores, quenchers, internal modifications)
- Delivered yield requirements (how much do you want to receive)
- Purification and minimum purity requirements
- Product Labeling or Certificate of Analysis requirements, if custom.
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