Lyophilization Service for Molecular Diagnostics
BIORI provides custom lyophilization development for PCR, qPCR, RT-qPCR and related molecular diagnostic reagents for IVD manufacturers. Services cover formulation assessment, lyophilization-cycle development, assay-ready formats, pilot evaluation, packaging and scale-up support, customized around each customer’s assay, instrument, reaction volume, target panel and quality requirements.
- 300,000
- Beads/Batch
- 3–7
- Day Turnaround
- ISO 13485
- GMP-Aligned
- Batch Traceability
Custom Lyophilization Capabilities
- PCR & qPCR Systems
- RT-qPCR & Isothermal Amplification Reagents
- DNA & RNA Enzymes
- Reaction Buffers & Stabilization Components
- Internal Controls & Reference Standards
- Lyophilized Beads (Single-Tube or Strip)
- 8-Tube Strips
- 96-Well Plates
- Pre-Filled Reaction Tubes
- Vials (Bulk or Single-Use)
- Custom OEM Packaging Formats
OEM Lyophilization Workflow
Quality Systems & Compliance
ISO 13485 Certified · GMP-Aligned Cleanroom Production
Ensuring batch-to-batch consistency and full regulatory documentation support.
Proof of Quality & Scale
- Release Testing
- Stability Validation
- COA & Regulatory Documentation
- 300,000 Beads/Batch
- 3–7 Day Turnaround
- Strict Traceability
Frequently Asked Questions
What information is needed to start a BIORI OEM lyophilization project?
To start a BIORI OEM lyophilization project efficiently, please share:
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Product concept & intended use (application, target market, RUO/IVD, performance goals)
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Required format (liquid/lyophilized, singleplex/multiplex, packaging and label requirements)
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Technical details (target list/sequence if applicable, sample type, workflow and instrument/platform compatibility)
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Quality & compliance expectations (ISO requirements, QC items, acceptance criteria, documents needed such as COA/SDS)
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Demand & timeline (estimated annual volume, pilot quantity, desired milestones, delivery terms)
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Reference materials (existing formulation/specs, competitor benchmark, any available validation data)
Explore BIORI’s Molecular Diagnostics solutions and OEM Service capabilities.
Can BIORI lyophilize an existing liquid formulation?
Yes. BIORI can evaluate your current liquid formulation and develop a lyophilization strategy to maintain performance and stability. Typically we will:
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Perform a feasibility assessment (compatibility, excipient review, key risks)
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Optimize lyoprotectants, buffer system, and drying cycle (primary/secondary drying)
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Verify post-lyo performance vs. your liquid baseline (sensitivity, specificity, repeatability)
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Provide recommended storage/shipping conditions and stability plan
If needed, we can also propose a reformulation to improve cake quality, reconstitution time, and long-term stability.
What is the typical lead time for samples and prototypes?
BIORI lead times depend on project complexity and material availability. As a general reference:
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In-stock evaluation samples: typically 5–10 business days after confirming requirements
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Customized prototype (lab scale): typically 2–4 weeks
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Lyophilized prototype with cycle optimization: typically 4–8 weeks
We will confirm a specific timeline after reviewing your requirements, target list, and validation scope.
What documentation and compliance materials does BIORI provide?
BIORI provides a documentation package aligned with regulated workflows, which may include:
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COA (lot-specific Certificate of Analysis)
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SDS (Safety Data Sheet)
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TDS / Product Specification and storage/shipping guidance
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Lot traceability information and key QC records (upon request)
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Quality system statements (e.g., ISO-managed QMS) and supporting compliance files as applicable
The exact document set can be tailored based on your market, regulatory pathway, and internal QA requirements.
Learn more about BIORI’s Manufacturing & Quality systems.
