OEM Reagents for Molecular Diagnostics
BIORI develops custom molecular diagnostic reagents through formulation, pilot evaluation and manufacturing support, with packaging and documentation built around your assay.
OEM reagents and bulk supply,
on clear terms.
What you can source from BIORI as OEM or private label.
Recent OEM supply projects
Define the reagent
your assay needs
Build the project around assay performance first, then specify the concentration, final format and manufacturing route.
01 — 05Formulation and performance requirements are evaluated within the intended assay system.
Formulation & system compatibility
Buffer, Mg²⁺, salt and pH compatibility for your assay and platform.
Enzyme activity & performance
Activity, speed, efficiency and consistency against agreed requirements.
Sensitivity optimization
Low-copy performance and Ct consistency under agreed assay conditions.
Contamination control & specificity
UDG carryover control and specificity within the reagent system.
Residue & background control
Low-residue, low-DNA and clean no-template controls for your application.
Choose how it is delivered
The same project can include format selection, concentration and lyophilization development.
Format & manufacturing process
Liquid, glycerol-free or lyophilized reagents for the final workflow.
Concentration & specification
2×, 4× and custom reaction volumes or pack sizes defined in the project brief.
Full-process lyophilization
Support from primers and probes through drying, QC and delivery when a dry format is required.
Browse molecular diagnostic reagents ↗
Your OEM project,
step by step
Seven steps, with the scope and acceptance criteria agreed before pilot development begins.
Start with your assay brief
Target assay & sample type
Instrument & reaction volume
Required format & expected volume
Scope & agreement
01Inquiry & requirement intake
Share the assay, sample type, instrument, reaction volume, required format and expected volume.
CheckpointProject requirements- 02
Technical evaluation & feasibility
Review formulation needs, platform compatibility and the proposed route to a pilot.
CheckpointFeasibility scope - 03
Quotation & agreement
Agree on scope, deliverables, acceptance criteria, packaging and documentation before work begins.
CheckpointAgreed project scope Development & verification
04Sample / pilot production
Prepare the agreed reagent format for technical review and customer evaluation.
CheckpointPilot material- 05
Method / performance verification
Evaluate the pilot against the performance and acceptance criteria agreed for the project.
CheckpointVerification review Manufacturing & delivery
06Scale-up & manufacturing
Transfer the approved reagent route into a controlled manufacturing plan.
CheckpointManufacturing plan- 07
QC release & delivery
Review the lot against its release specifications and prepare the agreed delivery documentation.
CheckpointReleased lot & records
Quality controls.
Documented at every handoff.
Define the release checks and supporting records your team needs for supplier review and ongoing supply.
QA/QC review & release
Defined specifications, release checks and records.
Batch traceability
Lot-level traceability from materials to shipment.
Documentation package
COA, TDS, SDS and other agreed supporting files.
Change control
Controlled updates with customer notification.
Stability & storage guidance
Stability planning, storage and shipping recommendations.
Long-term supply planning
Forecast alignment and capacity reservation options.
Prepared for your
next stage of production
Specify packaging, labeling and shipping requirements alongside the reagent itself.
Packaging formats
Single- or multi-tube packs, 8-strip tubes or 96-well plates when applicable, bulk bottles and aliquots.
Labeling & private branding
Your brand, with the agreed lot, expiry and traceability information.
Kitting & assembly
Component sets, sub-packs and ready-to-ship kit configurations.
Shipping & storage
Dry ice, ice packs or ambient shipping as applicable, with packing list and export document support.
Final configurations and documentation are agreed within the project scope.
OEM service
questions, answered
Scope, MOQ, lead time, formats, documentation and confidentiality.
What can BIORI customize in an OEM reagent project?
Customization can cover formulation and system compatibility, enzyme performance, sensitivity, contamination and background control, product format, concentration, lyophilization workflow, packaging, labeling, and documentation, based on the agreed project requirements.
Which BIORI products are available for OEM or private label?
Almost the entire BIORI product line can be supplied as OEM or private-label products, including enzymes, master mixes and instruments.
Is there a minimum order quantity (MOQ) for OEM reagents?
No. BIORI has no minimum order quantity for liquid or lyophilized OEM reagents.
What is the typical lead time for OEM orders?
OEM orders are typically delivered in about 14 days. For custom development projects, the timeline is confirmed after the feasibility review.
Which formats and pack sizes are available, including bulk supply?
Options include liquid, glycerol-free or lyophilized formats; single- or multi-tube packs; strips or 96-well plates when applicable; and OEM or private-label configurations. Pack sizes are customized, from small aliquots up to 1 L bulk bottles.
What does the BIORI OEM workflow include?
The workflow covers requirement intake, technical evaluation and feasibility, quotation and agreement, sample or pilot production, method and performance verification, scale-up manufacturing, and QC release and delivery.
What quality and regulatory documentation can BIORI provide?
Project support can include defined release checks, lot-level traceability, change control, stability and storage guidance, and documentation such as COA, TDS and SDS. BIORI also provides full documentation packages to support CE and IVDR registration of your assay; clinical performance studies are arranged by the customer, for example through a CRO.
How are confidentiality and formulation ownership handled?
BIORI signs an NDA before technical details are shared, and custom formulations developed in an OEM project belong to the customer.
Tell us what your reagent needs to do
Share the assay, platform, desired format and expected volume to begin a technical discussion with BIORI.
Frequently Asked Questions
What can BIORI customize in an OEM reagent project?
Customization can cover formulation and system compatibility, enzyme performance, sensitivity, contamination and background control, product format, concentration, lyophilization workflow, packaging, labeling, and documentation, based on the agreed project requirements.
Which BIORI products are available for OEM or private label?
Almost the entire BIORI product line can be supplied as OEM or private-label products, including enzymes, master mixes and instruments.
Is there a minimum order quantity (MOQ) for OEM reagents?
No. BIORI has no minimum order quantity for liquid or lyophilized OEM reagents.
What is the typical lead time for OEM orders?
OEM orders are typically delivered in about 14 days. For custom development projects, the timeline is confirmed after the feasibility review.
Which formats and pack sizes are available, including bulk supply?
Options include liquid, glycerol-free or lyophilized formats; single- or multi-tube packs; strips or 96-well plates when applicable; and OEM or private-label configurations. Pack sizes are customized, from small aliquots up to 1 L bulk bottles.
What does the BIORI OEM workflow include?
The workflow covers requirement intake, technical evaluation and feasibility, quotation and agreement, sample or pilot production, method and performance verification, scale-up manufacturing, and QC release and delivery.
What quality and regulatory documentation can BIORI provide?
Project support can include defined release checks, lot-level traceability, change control, stability and storage guidance, and documentation such as COA, TDS and SDS. BIORI also provides full documentation packages to support CE and IVDR registration of your assay; clinical performance studies are arranged by the customer, for example through a CRO.
How are confidentiality and formulation ownership handled?
BIORI signs an NDA before technical details are shared, and custom formulations developed in an OEM project belong to the customer.
