Recombinant Proteins & Diagnostic Enzymes

Elise Biopharma is a specialist microbial CDMO built to transform DNA sequences into compliant, market-ready products—whether they are high-potency therapeutic proteins for human health, critical diagnostic enzymes for in-vitro assays, or custom research reagents for next-gen discovery.

Our 4 000 ft² modular cleanroom campus in the United States integrates synthetic-biology strain creation, advanced bioprocess development, digital PAT monitoring, and ISO-/GMP-aligned manufacturing under one roof. From 5 L benchtop feasibility runs through 2 000 L commercial fermentation and robotic aseptic fill-finish, we combine scientific depth with operational excellence to deliver proteins that meet the world’s most demanding quality and regulatory standards.

Upstream Excellence – Strain & Fermentation Engineering

Synthetic-Biology Strain Design

Capability	Details	Benefit to Client
CRISPR/Cas & λ-RED editing	Seamless genome integration, pathway knock-outs	High copy / low burden chassis, reduced by-products
Codon-optimized gene synthesis	Host-specific bias, mRNA-stability prediction	Faster expression screening, fewer silent failures
Inducible & secretion promoters	T7, arabinose, AOX1, GAP, α-factor	Tight regulation, secretion when needed
Adaptive-laboratory evolution	Directed adaptation to pH, solvent, temperature	Robust growth, stable titer in industrial media

Fermentation Process Development

• Scales: 5 L → 20 L (development) → 200 L (pilot) → 2 000 L (GMP)
• Modes: Batch, fed-batch, continuous perfusion (E. coli and Pichia)
• Media Engineering: Chemically defined or complex media; AI-optimized C/N feeds to minimize acetate, methanol, or ammonia spikes
• Real-Time PAT: Raman/FTIR, inline biomass & capacitance, off-gas analytics for OUR/CTR control loops
• Digital Twin Modeling: Machine-learning algorithms predict oxygen demand, heat load, and pH drift—shortening scale-up campaigns by up to 30 %

Downstream Purification & Formulation

Collaboration Models

Unit Op	Resin / Membrane Examples	Typical Target
Affinity Capture	Ni-NTA / Strep-Tactin / CBD	His-tagged enzymes, cytokines
Ion-Exchange (IEX)	Capto Q, Capto S, Q Sepharose	Antibody fragments, VLPs
Hydrophobic/HIC	Butyl-S, Phenyl, Octyl resins	Aggregation-prone payloads
Mixed-Mode	Capto MMC, Nuvia, Toyopearl	Highly basic or acidic proteins
Size-Exclusion SEC	Superdex, Superose	Final polishing, aggregate removal
Membrane UF/DF	Spiral & cassette (5–750 kDa MWCO)	Buffer exchange, concentration

Diagnostic-Grade Purity & Lot-to-Lot Reproducibility

• Endotoxin: < 0.05 EU mg⁻¹ for IVD; < 1 EU mg⁻¹ for therapeutics
• Residual DNA: < 10 ng mg⁻¹ (qPCR)
• Host-Cell Proteins: Vendor-qualified HCP ELISAs or LC-MS panels
• Aggregate Control: SEC-MALS profile and DSC for each lot with acceptance criteria locked via DoE.

Formulation & Fill-Finish

• Buffer scouting (pH 4–9, ionic strength, polysorbate, arginine)
• Liquid or lyophilized dosage, ≤ 0.25 mL dead volume
• Fed-batch robot loader in ISO 5 isolator; 100 % in-line weight check
• ISO 13485 documentation plus GMP CoA or Device Master Record (DMR)

Product Classes We Support

Therapeutic & Vaccine Proteins

• Enzyme-Replacement Therapeutics – α-Galactosidase, GAA, ADA
• Cytokines & Growth Factors – IL-2 muteins, GM-CSF, BMP-7
• Antibody Fragments – scFv, Fab, sdAb/nanobody, minibody constructs
• Vaccine Antigens & VLPs – Influenza HA, RSV F, HPV L1 VLPs
• Payload Scaffolds for ADCs – cysteine-engineered linkers, SNAP-tag fusion proteins

Quality, Compliance & Regulatory Alignment

Framework	Scope at Elise	Benefit
cGMP	21 CFR 210/211 for therapeutics	IND/BLA readiness
ISO 13485	Design & mfg of IVD enzymes	CE IVDR / FDA 510(k)
ISO 9001	General QMS backbone	Continuous improvement
Part 11 e-Records	Electronic batch & audit trail	Paperless compliance

• Annual mock FDA & notified-body audits
• Process validation (PPQ) & cleaning validation per product family
• Viral safety / TSE risk assessed (microbial hosts)

Digital & Innovation Edge

• AI-Driven DoE: Bayesian optimization cuts scouting runs by 40 %
• Digital Batch Records: Scan-code material tracking, real-time deviation alerts
• IoT PAT Dashboard: Cloud-hosted; clients see live DO, pH, OD, feed rate, and alarm states
• Sustainability Metrics: Continuous water re-use skid, solvent-capture chromatography, carbon-footprint dashboard available for ESG reporting

Model	Ideal For	Highlights
Feasibility Sprint (≤ 6 weeks)	Early R&D, new target	5 L run, rapid analytics, go/no-go data pack
Gene-to-IND Package	Venture/biotech, seed to Series B	Strain → Process → GMP DS + CMC dossier
IVD OEM Supply	Diagnostics majors, kit makers	ISO 13485 lot release, private-label fill
Commercial Transfer	Upscaling existing process	Gap analysis, comparability, PPQ, launch

Why Clients Stay with Elise

1. Technical Depth – Ph.D.-level teams in fermentation, analytics, bioinformatics.
2. End-to-End Continuity – One campus for strain, process, GMP, and ISO 13485 fill.
3. Right-Sized Flexibility – < 5 g preclinical lots to > 20 kg commercial campaigns.
4. Regulatory Foresight – IND, BLA, CE IVDR, and 510(k) dossier experience.
5. Transparent Data Access – 24/7 client portal with batch, QC, and PAT data.

Ready to Accelerate Your Protein or Enzyme Program?

Connect with Elise Biopharma to leverage our synthetic-biology expertise, scalable microbial capacity, and world-class quality systems. From first milligram to commercial metric ton, we deliver proteins and enzymes that advance human—and diagnostic—health.