OEM & Custom Manufacturing Service

ISO-managed quality system with GMP-aligned operations—supporting formulation, scale-up, QC release, and documentation for your regulated pathway.

Service Scope

A flexible, end-to-end OEM offering—from wet formats to lyophilized beads, with specs, packaging, and documentation tailored to your needs.

Formulation System Compatibility
Formulation & System Compatibility

Buffer, Mg²⁺/salt, pH, and platform compatibility.

Enzyme Activity Performance 1
Enzyme Activity & Performance

Activity, speed, efficiency, and consistency.

Sensitivity Optimization
Sensitivity Optimization

Low-copy performance with consistent Ct.

Contamination Control Specificity
Contamination Control & Specificity

UDG carryover control and specificity boost.

Residue Background Control
Residue & Background Control

Low-residue, Low-DNA, and clean NTCs.

Form Manufacturing Process
Form & Manufacturing Process

Liquid, glycerol-free, or lyophilized formats.

Concentration Specification
Concentration & Specification

2×/4× and custom volumes & formats.

Full process Lyophilization Service
Full-process Lyophilization Service

From primers/probes to QC and delivery.

OEM Workflow

From requirement intake to delivery—clear milestones, defined QC gates, and traceable documentation.

Inquiry Requirement Intake
Inquiry & Requirement Intake
Technical Evaluation Feasibility noborder
Technical Evaluation & Feasibility
Quotation Agreement
Quotation & Agreement
Sample Pilot Production 2
Sample / Pilot Production
MethodPerformance Verification
Method/Performance Verification
Scale Up Manufacturing 2
Scale-Up & Manufacturing
QC Release Delivery
QC Release & Delivery

Quality & Compliance Support

Structured QA/QC, traceability, and documentation—built for consistent performance and reliable delivery.

QA QC Review Release
QA/QC Review & Release

Defined specs, release checks, and records.

Batch
Batch Traceability

Lot-level traceability from materials to shipment.

Documentation Package
Documentation Package

COA, TDS, SDS, and supporting files.

Change Control
Change Control

Controlled updates with customer notification.

Stability Storage Guidance
Stability & Storage Guidance

Stability plan, storage, and shipping recommendations.

Long term Supply Planning
Long-term Supply Planning

Forecast alignment and capacity reservation options.

Deliverables & Packaging Options

From bulk supply to ready-to-sell formats—custom labeling, packaging configurations, and documentation delivered to match your market and workflow.

Packaging Formats
Packaging Formats
Labeling Private Branding
Labeling & Private Branding
Kitting Assembly Options
Kitting & Assembly Options
Shipping Storage Setup
Shipping & Storage Setup

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 reagent formats and packaging options are available?

Options shown on this page include liquid, glycerol-free, or lyophilized formats; single- or multi-tube packs; strips or 96-well plates when applicable; bulk bottles or aliquots; and OEM or private-label configurations.

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 documentation support can be included?

Project support can include defined release checks, lot-level traceability, change control, stability and storage guidance, and documentation such as COA, TDS, SDS, and other agreed supporting files.

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