Stability. Sterility. Scalability. Delivered.
At Elise Biopharma, formulation and fill/finish aren’t just the final steps—they’re critical inflection points that define your product’s performance, shelf life, and patient experience. We combine cutting-edge formulation science with GMP-compliant fill/finish oElise Biopharma offers expert formulation and GMP fill/finish services for biologics, mRNA, peptides, and fusion proteins. From lyophilization to aseptic vial and syringe filling, we ensure stability, sterility, and scalability for your therapeutic.perations to support a wide range of biologics, peptides, mRNA, and fusion proteins.
From early-stage stability screening to aseptic filling in vials, syringes, or LNPs, we ensure your therapeutic arrives potent, pure, and ready for market.
Our Capabilities
🧪 Formulation Development
- Liquid and lyophilized formulation design
- Excipient screening & compatibility studies
- pH, osmolality, and buffer system optimization
- High-concentration protein formulations (>100 mg/mL)
- Thermal, photostability, and freeze-thaw profiling
- mRNA, protein, and ADC formulation expertise
- LNP formulation (ionizable lipid tuning, PEG ratios, size control)
🧊 Lyophilization & Stability
- Cycle development (primary & secondary drying optimization)
- Cake structure evaluation and residual moisture control
- Real-time and accelerated ICH stability studies
- In-house freeze dryers for rapid turnaround
- Compatibility with mAbs, enzymes, cytokines, and peptides
💉 Fill/Finish Operations
- GMP-compliant aseptic fill/finish (liquid & lyophilized)
- Vial, pre-filled syringe (PFS), and cartridge formats
- Batch sizes from R&D (<100 units) to pilot (up to 10,000 units)
- Closed-system filling and single-use isolators
- 100% fill volume verification and in-process visual inspection
- Terminal sterilization options where appropriate
- Sterility assurance with redundant filter integrity checks
🔬 In-Process Controls & Release Testing
- Fill weight accuracy & precision
- Particulate and endotoxin testing (USP <788>, <85>)
- Osmolality, pH, viscosity, and concentration
- Container-closure integrity (CCI) testing
- Extractables & leachables (E&L) compatibility studies
Modalities We Support
- Monoclonal & bispecific antibodies
- Fc-fusion proteins and cytokines
- Recombinant enzymes and hormones
- Nanobodies and VHHs
- mRNA vaccines & therapeutics (LNP-based)
- Peptides and oligonucleotide therapeutics
- Antibody–Drug Conjugates (ADCs)
- Diagnostic reagents and companion biologics
Why Elise Biopharma?
✅ Integrated Formulation & Fill Team
Formulation scientists and GMP operators work side-by-side, ensuring smooth tech transfer and minimal bridging studies.
✅ LNP and Biologic Expertise
We formulate fragile payloads including mRNA and cytotoxic proteins, using proprietary buffer systems and encapsulation techniques.
✅ Flexible Formats
Whether you’re moving toward clinical trial supply or producing an emergency-use investigational lot, we offer flexibility in vial sizes, syringe formats, and lyophilized cakes.
✅ Built for Speed & Compliance
With small-batch fill/finish capacity and full ICH-compliant documentation, we help clients meet aggressive timelines without sacrificing quality.
Batch Size & Format Options
| Format | Volume Range | Unit Type | Status |
|---|---|---|---|
| Glass Vials | 0.5–10 mL | Liquid/Lyo | GMP & non-GMP |
| PFS (Syringes) | 0.5–3 mL | Liquid | GMP (pilot scale) |
| LNP Formulations | 0.1–1.5 mL | LNP-mRNA | Preclinical/GMP-lite |
| Cartridges | 1–5 mL | Liquid | Engineering run |
Partner With Us
Formulation and fill/finish are the final gatekeepers of product success. Elise Biopharma brings together formulation chemistry, aseptic excellence, and rigorous analytics to help you cross that threshold with confidence.
📦 Ready to transfer your molecule or formulation?
Our team can design, optimize, and execute a fill/finish campaign tailored to your modality, timeline, and regulatory path.