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
Contacto rápido

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