Introduction
At a staggering -196°C, cryopreservation is more than just a freezing technique, it is the backbone of long-term biological research and therapeutic development. As biotech and pharmaceutical industries evolve to deliver advanced therapies faster and more reliably, the demand for sample stability, integrity, and replicability has never been greater. At Denovo, we understand that the foundation of cutting-edge biosimilar development, ELISA kit validation, and assay innovation begins with reliable sample preservation.
In this blog, we delve into how cryopreservation underpins everything from biosimilar analytical support to custom assay development, and why our cryostorage infrastructure is vital to ensuring reproducible science, regulatory compliance and faster product commercialization.
1. What is Cryopreservation, why do it?
Cryopreservation involves the cooling of cells, biological tissue, or any other substances susceptible to damage caused by chemical reactivity or time. Freezing samples at ultra-low temperatures halts all biological activity, allowing the material to be stored for extended periods without degradation.
In the biopharma sector, this method is indispensable. From hybridomas used to produce monoclonal antibodies, to patient-derived plasma samples for PK/PD studies, cryopreservation ensures that biological reagents remain viable, reproducible, and ready for downstream processing.
Key Benefits of Cryopreservation:
- Sample Integrity: Prevents loss of function or viability
- Consistency in Assays: Enables standardization across multiple batches
- Regulatory Readiness: Facilitates GLP-compliant documentation and audit trails
- Reduced Costs: Minimizes waste by allowing reuse of rare and expensive samples
2. How we use Cryopreservation to support you?
Denovo Biolabs offers robust, in-house cryostorage capabilities that serve as the cornerstone of many client-facing services. We utilize cryopreservation in the following critical operations:
a. Long-Term Storage of Cell Lines:
Our repository of hybridomas and recombinant cell lines, the key sources for monoclonal antibodies are preserved using controlled-rate freezing techniques and stored in liquid nitrogen tanks. This ensures the genetic and functional consistency of these cell lines, vital for custom ELISA kit development and antibody assay reproducibility.
b. Plasma/Serum Sample Banking:
PK/PD studies often involve thousands of samples over multiple time points. At Denovo, we cryopreserve biological matrices in a GLP-compliant manner, ensuring sample consistency for longitudinal studies.
c. Reference Standards & Reagents:
Our biosimilar ELISA kits depend on reference materials that must remain stable across test lots. Cryopreservation allows us to maintain and batch-validate these materials, reducing variability and ensuring assay reliability.
d. Cryo-Support for Tech Transfer & CDMO Handover:
Biopharma firms working with CDMOs or CROs often require seamless tech transfer. Denovo supplies cryopreserved aliquots of validated cell lines or reagents to ensure no loss of performance during external scaling.
3. Cryopreservation & Assay Development
Precision assays like those developed at Denovo Biolabs — including ADA (anti-drug antibody), PK/PD (pharmacokinetics/pharmacodynamics), and immunogenicity assays — require consistency at every step. A single deviation in reagent integrity can compromise data quality.
By cryopreserving validated reagents and reference standards, Denovo ensures that:
- ELISA kits perform identically across test runs
- Custom assay batches are traceable and repeatable
- Clients can scale up research without re-validation
This standardization reduces time-to-market and lowers compliance risk — essential benefits in today’s competitive biosimilar space.
4. Our Cryopreservation Infrastructure
Denovo Biolabs operates with high-capacity liquid nitrogen tanks, temperature monitoring systems, and backup power to prevent deviations. Each cryovial, rack, and tank is catalogued and monitored via barcoded inventory systems, ensuring:
- 24/7 traceability
- Alarm-based deviation alerts
- SOP-driven access protocols
- GLP-aligned documentation
We also offer cryostorage as a standalone service for partners who need a secure and compliant location to store their critical assets.
5. Services backed by Cryopreservation
Beyond sample storage, cryopreservation strengthens our ability to deliver:
- Custom Biosimilar ELISA Kits: Developed using long-term preserved cell lines
- Monoclonal/Polyclonal Antibody Assays: Enabled by cryostored hybridomas
- Protein A/Protein G Detection Kits: Stabilized reagents maintained via cryopreservation
- Bioprocess Monitoring: Reliable standards for QC across product batches
- Tech Transfer Support: Reagent and reference material archiving for seamless external handover
6. The Future of Affordable Healthcare
Biosimilar innovation is critical to making healthcare more affordable. Denovo’s cryopreservation infrastructure directly supports this mission by ensuring that products are built on reproducible science, that processes are scalable, and that regulatory hurdles can be navigated confidently.
With over a decade of experience supporting Indian and global biotech firms, Denovo Biolabs is more than a service provider — we’re a partner in the long-term success of every molecule and every mission.
Cryopreservation is a quiet powerhouse behind the scenes of drug discovery and development. We want to ensure that every client of ours can build with confidence, scale with certainty, and succeed with science.
Looking to store your cell lines, reference samples, or critical reagents with confidence?
Reach out to Denovo Biolabs today: