GMP, OEM and Integrations

Overview

IDT’s expertise in GMP manufacturing allows us to help you through every step of your assay development, from discovery to commercialization. We offer a streamlined portfolio to aid in GMP service selection and order processing, with transparent pricing. When you are ready to move to GMP manufacturing, we offer control (change control, device master record indexes) and consistency (lot-to-lot consistency and std or custom QC).

Strategic Partner

As you develop your molecular diagnostic or OEM assay, you need a strategic partner to help you meet your revenue goals with high-quality reagents, on-time delivery, and the ability to grow with you. With IDT, you can rely on:

• >30 years of experience in oligonucleotide manufacturing
• >65,000 oligos synthesized/QC tested per day
• >500 diagnostic and biotech customers served
• >1000 GMP/ assays commercialized using IDT components
• Picomole -> multi-gram single-lot scalability

Innovative Products

IDT is your innovative expert with a broad product portfolio, tools that guide experimental design, expert technical support, and rapid turnaround times. You can count on:

• Access to >500 modifications and modified bases
• Intuitive design tools for PCR, qPCR, NGS, and CRISPR
• An easy-to-order web tool for RUO and GMP oligos
• >20 regionalized scientific application specialists and >90 customer support staff—available via phone, chat, and email

Flexible Manufacturing

Your product demand has grown, and now it is time to scale up with maximum efficiency. To do this, you will need an experienced collaborator who can provide scalability and manufacturing flexibility. IDT’s expertise will support this process through:

• Robust manufacturing capabilities (>90,000 GMP oligonucleotides synthesized per year)
• Picomole to multi-gram single-lot scalability
• Bulk formulations, third party reagent sourcing, drop-in components, and finished kit options available
• Your oligos, your way (plates and tubes, custom formulations/spec sheets, your packaging)

Quality First

IDT puts quality first with:

• ISO 13485 and ISO 14644 certifications
• US FDA registration, as required
• Traceability to support your customers—LIMS batch history record for every GMP oligo, Change Control Notification (CCN) service, including right to approve
• >35 successful audits per year

Reliable Service

IDT Strategic Services is an ally who can help manage all aspects of ordering and integration, with options to help you meet your budget, including:

• >30 dedicated, single-point-of-care account managers with 2–17 years of customer service experience
• Full-featured integration API, with proven integration experience (>200 existing customer integration relationships using Arriba, Jaggaer {formerly SciQuest}, Coupa, or direct options)
• Customer-specific inventory builds
• Inventory reports
• License-free fluorophores and competitive pricing options
• Flexible supply options, including scheduled delivery and direct drop-ship available in some regions

More information