Lyophilization stability of biologics, diagnostics and reagents is a constant challenge. One proven solution? Lyophilization, also known as freeze-drying is a technique that plays a pivotal role in improving product shelf-life, stability and usability across industries like biopharma, diagnostics and research.
At Denovo Biolabs, our lyophilization services are purpose-built to support research institutes, biotech innovators, and diagnostic manufacturers seeking consistency, reliability, and precision in their products.
What is Lyophilization?
Lyophilization is a dehydration process used to preserve perishable materials or make substances more convenient for transport and storage. It works by: Freezing the product below its eutectic temperature Applying vacuum to sublimate ice directly into vapor (primary drying) Removing bound moisture through desorption (secondary drying) This process results in a dry, porous product that can be reconstituted with high fidelity—critical for applications where activity, potency, or structure must be retained.
Why Lyophilization?
Lyophilization is not just about drying. It’s about preserving function and ensuring reproducibility.
Here’s why biotech and diagnostics companies trust lyophilization: Increased Stability: Protects temperature-sensitive reagents like enzymes, antibodies, and diagnostic substrates. Extended Shelf Life: Critical for global shipping and decentralized diagnostics (like LFA test kits). Easy Reconstitution: Ensures rapid, uniform activation of biologics and reagents. Accurate Dosage & Potency: Reduces degradation and batch variation.
Applications We Support
Denovo’s lyophilization facility is tailored to support:
Lateral Flow Assay (LFA) Components Conjugates, pads, and detection antibodies in lyophilized format for room temperature stability.
Diagnostic Reagents & Antigens HIV, HCV, and other diagnostic proteins stabilized for shipping and use in varied climates.
Cell Culture Media Additives Freeze-dried supplements that retain activity when rehydrated.
Biosimilar PK/ADA Kit Components Enhance the shelf-life of key assay reagents while maintaining assay sensitivity and performance.
Denovo’s Capabilities
We offer:
Small & Large Batch Processing From pilot-scale to commercial runs
Custom Formulation Support Buffer optimization for maximum stability
Controlled Lyophilization Cycles Validated protocols for proteins, antibodies, antigens, and assay reagents
Packaging & Storage Delivered in your preferred format—vials, cassettes, or custom containers
Our Process: End-to-End Lyophilization Partnership
Feasibility Study – Assess the freeze-dry compatibility of your product Formulation Development – Optimize stabilizers, excipients, and buffers Cycle Development – Design primary and secondary drying phases Analytical Support – Post-lyo quality checks (activity, reconstitution, purity) Scale-Up & Production – GMP-compliant batch processing
Why Clients Choose Denovo
Trusted by R&D & Diagnostic Manufacturers Globally ISO-Certified Facilities with Cleanroom Setup Flexible MOQs and Competitive Turnaround Make-in-India Advantage without Quality Compromise
Let’s Build Stability Into Your Products
Whether you’re developing a rapid test, scaling a biotherapeutic assay, or stabilizing reagents for global deployment—our lyophilization services are designed to match your scientific goals with commercial efficiency.
Want to explore how lyophilization can enhance your product’s performance and shelf life?
Let’s collaborate. Reach out to info@denovobiolabs.com or visit www.denovobiolabs.com