BIORI Service Center
Molecular Diagnostics Services for Assay Development and Manufacturing
BIORI offers formulation, custom assay development, lyophilization and manufacturing support for molecular diagnostic reagents, from feasibility to production.
- Service routes
- OEM, custom assays and lyophilization
- ISO 13485 QMS
- SGS-certified quality system
- Pilot lots
- No minimum order quantity for scoped projects
- Technical support
- Application scientists from brief to handoff
Start here
Find the right molecular diagnostics service for your project
OEM reagent manufacturing, HCD/HCP assay development and lyophilization.
OEM service
Custom reagent manufacturing
Formulation, bulk packaging, private label and scale-up support for molecular diagnostic enzymes and master mixes.
Explore OEM Service
HCD / HCP
Custom assay development
Process-specific residual host cell DNA and host cell protein assays matched to your host system, matrix and sensitivity requirements.
Explore HCD/HCP ServiceLyophilization
Dry reagent formats
Custom lyophilization development for PCR, qPCR, RT-qPCR and isothermal reagents, from formulation assessment to scale-up.
Explore Lyophilization ServiceHow our services work
How a service project runs
Whichever service you start with, the project moves through the same three steps: assay context, technical review, then pilot and handoff.
- 01
Share the assay context
Target, sample type, host system, instrument and required format.
- 02
Review the technical route
Our scientists map feasibility, formulation and validation requirements.
- 03
Move into pilot and handoff
Agree the final container, documentation and scale-up plan.
Explore each service
OEM, HCD/HCP and lyophilization in more detail
Each service page covers the scope, the data and how a project runs.
OEM service
From feasibility to scaled manufacturing.
Custom formulation, pilot evaluation and scaled manufacturing of molecular diagnostic enzymes and master mixes, with packaging and documentation built around your assay.
- Feasibility and formulation assessment
- Pilot evaluation and custom packaging
- Manufacturing and lot-to-lot consistency
HCD / HCP service
From sample context to validated assay.
Residual host cell DNA and host cell protein assays developed for your host system, sample matrix and sensitivity requirements.
- Residual host cell DNA assay development
- Host cell protein assay development
- Process-specific validation and transfer
Lyophilization service
Dry formats that are ready for the workflow.
Lyophilized PCR, qPCR, RT-qPCR and isothermal reagents, developed from formulation assessment and cycle development to scale-up.
- Formulation assessment and cycle development
- Beads, strips, plates, tubes and vials
- Pilot evaluation, packaging and scale-up
Send us your project brief
Share the target, sample type, platform and desired format. BIORI will route your brief to the right service team.
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. BIORI supports OEM projects from feasibility and formulation through pilot runs to scaled manufacturing of molecular diagnostic enzymes and master mixes.
Which molecular diagnostic reagents can be considered for lyophilization?
PCR and RT-qPCR master mixes and related assay components can be lyophilized. The final scope is defined for your formulation and workflow.
Can HCD or HCP assay development be matched to a specific process?
Yes. HCD and HCP assays are developed for your host system, sample matrix, sensitivity requirements and monitoring or release-testing workflow.
