Molecular Diagnostics Services for Assay Development and Manufacturing
From a first feasibility question to a production-ready reagent, BIORI brings formulation, custom assay development, lyophilization and manufacturing support into one coordinated service center.
Find the right molecular diagnostics service
for your project
Each route answers a different production question. Start with the closest match, then move into the detailed page for scope, evidence and next steps.
Custom reagent manufacturing
Formulation, bulk packaging, private label and scale-up support for molecular diagnostic enzymes and master mixes.
Explore OEM Service →
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 Service → Dry reagent formats
Custom lyophilization development for PCR, qPCR, RT-qPCR and isothermal reagents, from formulation assessment to scale-up.
Explore Lyophilization Service →Clear next steps for assay development and manufacturing
The service center gives buyers a simple route into the right team, while each detail page keeps the same rhythm: scope, capability, evidence and a direct CTA.
Target, sample type, host system, instrument and required format.
Our scientists map feasibility, formulation and validation requirements.
Agree the final container, documentation and scale-up plan.
Service details, evidence and next steps
Choose the service that matches your assay, then review scope, evidence and next steps on the dedicated page.
From feasibility to scaled manufacturing.
Lead with the project outcome, then make the production path visible in the first screen.
- Feasibility and formulation assessment
- Pilot evaluation and custom packaging
- Manufacturing and lot-to-lot consistency
From sample context to validated assay.
Make the host system, matrix and sensitivity questions explicit before the visitor reaches the form.
- Residual host cell DNA assay development
- Host cell protein assay development
- Process-specific validation and transfer
Dry formats that are ready for the workflow.
Carry over the existing lyophilization page's evidence-led language while making the service-center relationship obvious.
- Formulation assessment and cycle development
- Beads, strips, plates, tubes and vials
- Pilot evaluation, packaging and scale-up
Tell us where your assay needs to go
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. 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.
