Where Purity Meets Precision—Advanced Recovery of Complex Biologics
At Elise Biopharma, we bring scientific rigor and modern bioprocessing to the art of purification. From initial harvest to ultra-pure drug substance, our downstream purification and recovery workflows are designed to maximize yield, ensure product consistency, and meet the stringent purity and safety standards required for clinical and commercial success.
Whether you’re producing monoclonal antibodies, bispecifics, cytokines, or gene therapy vectors, our team delivers optimized, scalable, and regulatory-aligned purification processes tailored to your molecule.
Core Capabilities
Chromatography Method Development
Affinity, Ion-Exchange, Hydrophobic Interaction & Multimodal Strategies
Our purification scientists develop robust, high-resolution chromatography workflows using a combination of affinity, IEX, HIC, and mixed-mode columns to maximize purity and throughput.
Key Services:
- Protein A/G/L affinity capture for antibodies and Fc-fusions
- Cation & anion exchange (CIEX, AIEX) polishing steps
- Hydrophobic interaction chromatography (HIC) for aggregates
- Multimodal resin selection and optimization (e.g., Capto MMC, Nuvia)
- Step-gradient and continuous gradient method development
- Column packing, lifetime studies, and cleaning validation protocols
We leverage small-scale scouting, DoE-based optimization, and inline UV/conductivity monitoring to ensure seamless scale-up from bench to manufacturing.
Tangential Flow Filtration (TFF) & UF/DF
Volume Reduction, Buffer Exchange, and Final Concentration
Tangential Flow Filtration is a cornerstone of modern biologic purification—and Elise offers both low-volume and large-scale TFF solutions for recombinant proteins, antibodies, enzymes, and viral vectors.
Our TFF Capabilities Include:
- Ultrafiltration/Diafiltration (UF/DF) from 5 mL to 200+ liters
- Hollow fiber and cassette-based systems (0.1–750 kDa cutoffs)
- Buffer exchange, volume reduction, and final drug substance concentration
- Automated systems (AKTA Flux, Spectrum KrosFlo, Pall Cadence) for precise control
- Membrane selection based on fouling resistance, yield, and scalability
- Inline conductivity, pressure, and turbidity monitoring
Our teams develop process-specific TFF parameters including TMP, flux rate, and diafiltration volumes to achieve high product recovery with minimal shear or fouling.
Viral Clearance & Viral Safety Validation
Safety Is Not Optional—It’s Engineered In
Elise Biopharma integrates viral safety into every purification process with stepwise clearance studies and validation services that meet global regulatory standards.
Key Offerings:
- Viral clearance step integration in chromatography and filtration workflows
- Low pH virus inactivation, nanofiltration (20 nm–75 nm), and detergent treatment
- Modular viral safety validation strategy for CHO, E. coli, HEK293, and insect cells
- Support for regulatory filings: viral clearance summaries, validation protocols, and study reports
- Collaboration with third-party viral clearance CROs for GLP validation as needed
We embed these strategies into your process early—minimizing downstream surprises and maximizing regulatory confidence.
Supported Modalities
- Monoclonal antibodies and Fc-fusion proteins
- Recombinant enzymes and cytokines
- Nanobodies, bispecifics, and protein scaffolds
- AAV and LVV viral vectors
- Plasmid DNA and mRNA
- Diagnostic reagents and vaccine components
Facility & Scale Overview
| Process Step | Min Scale | Max Scale | Equipment Highlights |
|---|---|---|---|
| Chromatography | 1 mL | 30+ L | GE AKTA Avant, Pure, Ready |
| UF/DF (TFF) | 5 mL | 200+ L | KrosFlo, Pall, Sartorius |
| Nanofiltration | 50 mL | 100 L | Virus filters (20–75 nm) |
| Inactivation (low pH) | 10 mL | 50 L | Jacketed vessels, inline pH |
| Formulation & Freeze | 1 mL | 10 L | Controlled-rate freezer, Lyo |
Why Choose Elise?
✅ Platform Processes + Custom Design
We’ve developed plug-and-play downstream protocols for mAbs, enzymes, and fragments—plus the flexibility to customize for your novel modality.
✅ Full Integration With Upstream
As a true end-to-end CDMO, Elise connects upstream data (feed, titer, solubility) with downstream strategy to boost overall yield and reproducibility.
✅ Regulatory Confidence Built In
Each purification campaign includes in-process controls, release criteria, traceability, and optional validation protocols to support your IND/IMPD.
✅ Viral Vector-Specific Expertise
From AAV empty/full capsid separation to LVV nuclease treatment and capture, our gene therapy purification team understands your unique process demands.
In-Process Analytics
- UV280, conductivity, pH monitoring
- SDS-PAGE, SEC-HPLC, CE-SDS
- Endotoxin & host cell protein (HCP) assays
- qPCR and ddPCR for residual DNA
- AUC, DLS, and aggregate characterization
- Yield and step-recovery calculations across entire flowpath
Integrated Documentation & Quality System
- Batch records for each step with version control
- Standard and custom cleaning validation protocols
- Viral clearance documentation templates
- Process development reports and tech transfer packets
- QA/QC oversight throughout all purification campaigns
Partner With Elise
Downstream purification is where product becomes medicine. Whether you need a proven platform for antibody purification or a fully customized strategy for viral vectors or fusion proteins, Elise Biopharma provides the expertise, technology, and rigor to get you there.
Ready to purify your molecule at scale?
Contact our purification team to design a downstream process that’s robust, compliant, and ready for global markets.