One-Stop Shop. Built for Complexity.
With our end-to-end kitting services and 30 years of experience manufacturing custom reagents, you'll get access to dedicated support from industry experts who have been designing innovative solutions for decades and understand kit complexity.
Complete Manufacturing and Kitting Solutions
Get high-quality custom RUO and IVD kits, including NGS, PCR, and liquid biopsy assays, through one seamless workflow. We can manufacture your reagents, source specialized components from trusted vendors, design formats that integrate with your assay, and create custom packaging and labels to your exact specifications.
Fully integrated kits:
Formats that fit your assay
We manufacture and dispense reagents in the container format your system needs, from microliter volumes in plates to single-use bags for high-volume dispensing. We can also source and fill custom formats that integrate directly with your instruments and workflow.
End-to-end partnership:
We partner with you at every stage of your assay’s development, from initial concept through full-scale supply. Our integrated approach means you work with one trusted team that understands your goals and maintains continuity from first prototype to final delivery.
We manufacture and assemble kits for life sciences tools and diagnostics customers across molecular diagnostics, next-generation sequencing, PCR, spatial genomics, liquid biopsy, and more. We can manufacture the buffers and media for your kit, source specialized components from trusted vendors, and integrate customer-supplied materials into the final assembly.
Minimums depend on your kit’s components, formats, and grade. When we quote your kit, we’ll walk you through the minimum batch size for each reagent and how it fits your kit volumes.
Turnaround time depends on the complexity of your requirements, but our modular manufacturing platform and bracketed validation approach allow custom orders to move into production within weeks. Express•Tek℠ Production is available to help meet expedited timelines. See our standard turnaround times.
As a contract reagent manufacturer, we recognize the significant investment in research and development that goes into your prototypes. All engagements begin with a mutual non-disclosure agreement, and proprietary formulations, protocols, and specifications are controlled within our eQMS, which is part of our ISO 13485 QMS.
Yes. We can source raw materials from your preferred vendors, incorporate customer-supplied materials into manufacturing, and test them against your specifications. We can also facilitate alternate sourcing if a supplier issue arises during your program.
Our quality management system is certified to ISO 13485:2016 and covers document control, non-conformance and deviation management, corrective and preventive actions, raw material testing, in-process and finished goods testing, out-of-specification management, and internal audits. Our eQMS is MasterControl.
Yes. Our RUO+ grade is manufactured in the same facilities and on the same equipment as our GMP-grade products, giving you comparable quality without the added documentation and testing requirements that GMP demands. It’s an efficient, cost-effective way to move your assay from development to clinical trial assays and commercial IVD kits, and we support your diagnostic pipeline under one roof, from early discovery through commercial-scale GMP manufacturing. Learn more about our manufacturing grades.
Yes. We design and run accelerated and real-time stability programs to assign or extend shelf life for custom reagents, including stability studies for reagents not manufactured by us. Studies can cover pH, conductivity, density, osmolality, sterility, RNase and DNase, PCR performance, endotoxin, concentration, and application-specific activity. Learn more about our stability study options and pricing.
We dispense from microliter volumes in 96-well plates through liters in single-use bags up to 200 L. Standard formats include tubes, bottles, vials, and cryovials. For customers who need a container that integrates with a specific instrument or workflow, we can source or engineer custom solutions.
Yes. Custom branding, private-label packaging, and labels are all available if required. Labels, COAs, and batch records can also be customized to meet your specifications and regulatory requirements.
Yes. Our fulfillment and warehousing service covers dedicated storage for finished kits, raw materials, and customer-supplied components, with cold chain where required. We can operate consignment inventory, manage reorder points against your forecast, and ship direct-to-customer, direct-to-partner, or across your own sites with temperature-monitored shipping. This lets you consolidate a single large lot into predictable, on-demand supply from one supplier.
A short project brief is enough to begin: the reagents or components in your kit, the format and fill volumes you need, target grade (RUO, RUO+, or GMP), estimated annual volumes, and any specific documentation or QC requirements. Our technical team will review and follow up with specific questions to finalize your quote. Submit your request here to get started.
Our standard process includes a comprehensive suite of quality control assays that we perform on our raw materials and finished products. We maintain retention samples for the lifespan of each product so we can test its integrity at any time, and we can also perform custom QC testing or stability testing as required. Learn more about our QC testing.