Speed. Scalability. Consistency. Built for the diagnostic supply chain.
At Elise Biopharma, we specialize in contract development and manufacturing services tailored to the needs of today’s fast-moving diagnostic landscape. Whether you’re scaling production of a proprietary enzyme, optimizing lateral flow assay components, or seeking reliable supply of GMP-like RUO materials, our team delivers rapid, responsive support grounded in scientific rigor.
We understand that diagnostics requires a unique manufacturing mindset. It’s not just about purity or yield—it’s about lot-to-lot reproducibility, accelerated timelines, and regulatory clarity. Our microbial CDMO platform is engineered to deliver on these demands, combining high-throughput fermentation with precise downstream control, under ISO 13485-aligned quality systems.
With Elise Biopharma, diagnostic developers get more than a service provider. They gain a strategic manufacturing partner who understands the urgency, complexity, and quality requirements that define diagnostic product success.
We Enable the Backbone of Modern Diagnostics
From infectious disease detection to companion diagnostics for biologics, recombinant proteins and enzymes are foundational to today’s diagnostic platforms. These tools must be reproducible, stable, and available at scale. With our proven infrastructure and expert teams, Elise Biopharma helps diagnostic innovators move faster—without compromising on quality.
We partner with a wide range of diagnostic developers:
- Molecular diagnostics companies scaling up critical enzymes for RT-PCR and isothermal amplification
- Lateral flow assay manufacturers sourcing recombinant proteins and antibody fragments
- IVD companies expanding into global markets requiring ISO 13485-compliant production
- Emerging synthetic biology firms developing new detection chemistries
- Academic or translational research groups needing RUO-grade materials with future GMP potential
Whether you’re in early-stage prototyping or commercial launch, our diagnostic CDMO services are built to deliver speed, stability, and supply confidence.
Diagnostic Capabilities at a Glance
We offer a modular set of capabilities specifically suited to the diagnostic supply chain:
Enzyme Fermentation & Purification
Production of high-purity enzymes critical to molecular detection workflows:
- Bst polymerases (Bst 2.0, 3.0)
- Reverse transcriptases
- Taq polymerase
- RNase inhibitors
- Custom variants or novel enzyme discovery
We offer tight process control for enzyme yield, activity, and stability—backed by robust QC release data and formulation flexibility.
Recombinant Antigen & Protein Production
We express a wide variety of recombinant antigens and biosensor components for:
- ELISA kits
- Fluorescent or colorimetric detection systems
- Functional domain optimization (tags, linkers, fusion designs)
- Endotoxin-controlled purification and viral safety filtration
We can also produce spike proteins, bacterial/viral antigens, or synthetic analogs with high reproducibility.
Antibody Fragments for Lateral Flow Assays
Our microbial expression systems are ideal for rapid, cost-efficient production of:
- Fab, scFv, and VHH (nanobody) fragments
- Tags for conjugation (biotin, His-tag, etc.)
- Site-specific linker modifications
- Purity optimization for assay background reduction
These fragments are optimized for stability, solubility, and detection fidelity.
Endotoxin-Controlled Manufacturing
Endotoxin levels can severely impact diagnostic performance. Elise uses:
- Endotoxin-free reagents
- Chromatography-based removal techniques
- Final product testing to assure <0.1 EU/mL when required
For lateral flow, ELISA, and molecular workflows, this level of control supports consistent signal and reduced background noise.
ISO 13485-Aligned Quality Systems
We operate under ISO 13485-aligned systems, with traceable documentation and full QC support:
- Batch records, CoAs, and method validation
- Risk assessments, design control consultation
- Auditable quality systems and SOP frameworks
- Support for RUO, IVD, and 510(k) product classes
If needed, we can support eventual transition from RUO to GMP with structured scale-up and regulatory planning.
Speed and Stability from Lab to Market
Diagnostics operate on a different clock. We know your launch timelines are often in weeks—not months. Our systems are built to respond quickly, without sacrificing quality.
Why diagnostic companies choose Elise:
- Rapid onboarding — get from inquiry to production start in under 4 weeks
- Small to large-scale fermentation — from 2L to 200L+ with scalable tech transfer
- Lot-to-lot reproducibility — validated expression and purification SOPs
- Analytical and functional testing — enzyme kinetics, activity assays, endotoxin, SDS-PAGE, HPLC
- RUO, IVD, and pre-GMP alignment — we meet you where you are and scale with you
From COVID-19 detection to point-of-care cancer panels, our work supports diagnostic platforms impacting millions of lives.
Partner with Elise Biopharma for Diagnostic Success
Elise Biopharma isn’t just another CDMO. We’re a strategic extension of your team—scientifically fluent, fast-moving, and focused on quality. Whether you need a few grams of custom enzyme for feasibility or sustained batches of high-purity antigen for commercial kits, we’re here to deliver.
Our promise to you:
- Science-first partnership, not transactional service
- Transparent timelines and flexible engagement models
- High-touch communication from project kickoff to lot release
Get in Touch!
Your diagnostics deserve a partner who can keep pace.
Let’s accelerate your next breakthrough—together.