OEM & Custom Reagent Services
End-to-end OEM/ODM support for molecular diagnostic enzymes and master mixes—from feasibility and formulation to pilot runs and scaled manufacturing. Designed for performance, manufacturability, and consistent lot-to-lot quality.
Lyophilization Service for Molecular Diagnostics
Lyophilization development and manufacturing for molecular diagnostics—optimized for stability, transport, and field-friendly workflows. Suitable for PCR/RT-qPCR master mixes and related assay components.
HCD/HCP Custom Assay Development Service
Custom development for Residual Host Cell DNA (HCD) and Host Cell Protein (HCP) assays to support bioprocess monitoring and release testing. We help you build assays that match your host system, matrix, and sensitivity requirements.
Frequently Asked Questions
Which BIORI service should I choose?
Use the OEM service for enzyme or master-mix formulation and manufacturing projects, the lyophilization service for dried molecular diagnostic reagent formats, and the HCD/HCP service for process-specific residual host cell DNA or host cell protein assay development.
Can BIORI support an OEM project from feasibility through scaled manufacturing?
Yes. The service overview describes support from feasibility and formulation through pilot runs and scaled manufacturing for molecular diagnostic enzymes and master mixes.
Which molecular diagnostic reagents can be considered for lyophilization?
The service overview identifies PCR and RT-qPCR master mixes and related assay components as suitable examples, with the final scope defined for the customer's formulation and workflow.
Can HCD or HCP assay development be matched to a specific process?
Yes. The HCD/HCP service is intended to match the customer's host system, sample matrix, sensitivity requirements, and bioprocess monitoring or release-testing workflow.
