From Molecule to Market-Ready, All Under One Roof
At Biocronic, innovation and execution go hand in hand. Our integrated R&D and manufacturing setup is designed to take a recombinant antigen or antibody from sequence design all the way to validated, scalable production.
We don’t just formulate reagents, we engineer them end-to-end to meet the real-world demands of immunoassay development.
1. In-House Innovation Platform
Our multidisciplinary biotech team develops recombinant antigens and monoclonal antibodies through a rigorous, multi-step process:
- Sequence design
- Expression in mammalian or microbial systems
- Purification via FPLC (AKTA Pure)
- Bioanalytical QC, including:
- Spectrophotometry
- RT-PCR
- ELISA
- Western Blot
- Gel Documentation
- LC-MS
2. Strict Evaluation Standards
Every candidate molecule is assessed for:
- Reactivity
- Specificity
- Purity
- Stability
Only when a product passes internal QC and performs on the target immunoassay format (ELISA or LFA) is it handed off for production.
3. Scale-Up with Built-In Consistency
Our ISO 13485-certified and GMP-compliant facility is designed for high-purity production and lot-to-lot consistency, from sample-size volumes for early-stage R&D to full-scale batches for commercial use.
Key infrastructure and practices include:
- Mammalian and microbial cell culture capabilities
- Batch-to-batch QC tracking
- Cold-chain managed storage
- Full traceability for regulatory readiness
- ISO-aligned, GMP-informed workflows
Whether you’re validating a prototype or scaling up a product line, our combined R&D and manufacturing system ensures you receive stable, validated, and on-spec inputs every single time.
