Lyophilization Service for Molecular Diagnostics
- 300,000
- Beads/Batch
- 3–7
- Day Turnaround
- ISO 13485
- GMP-Aligned
- Batch Traceability
What We Deliver
- 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
Our End-to-End OEM 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 Dat Turnaround
- Strict Traceability
Frequently Asked Questions
What information is required to initiate an OEM project ?
To start an OEM 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)
Can you lyophilize our existing liquid formulation ?
Yes. We 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 standard lead time for sample delivery ?
Lead time depends 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 are provided ?
We provide 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.