Design. Develop. Deliver. At Scale.
Fc-fusion proteins and bispecific antibodies represent the cutting edge of biologic innovation—combining modular domains to engineer custom half-lives, dual targeting, or improved tissue specificity. At Elise Biopharma, we offer an integrated platform that spans early fusion design, Fc variant selection, bispecific format engineering, and full GMP-scale manufacturing.
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Whether you’re developing a cytokine-Fc fusion, an albumin fusion for enhanced half-life, or a T-cell engaging bispecific, Elise delivers the molecular design expertise, analytical depth, and manufacturing infrastructure to bring your complex biologic to life—efficiently and at scale.
Engineering Fc-Fusion & Albumin Fusion Proteins
From Linker to Half-Life: Fusion Biologics Built for Purpose
Fc-fusion proteins combine therapeutic payloads with Fc or albumin domains to extend serum half-life, enhance stability, or improve effector function. Our team specializes in designing constructs that are manufacturable, biologically active, and pharmacologically optimized.
What We Engineer
Fc-Fusion Proteins
We design and manufacture a wide spectrum of Fc-fusion biologics that combine therapeutic payloads with Fc domains for enhanced half-life, stability, and effector function. These include cytokine-Fc constructs (e.g., IL-2, IL-7, GM-CSF) for immune modulation, growth factor-Fc fusions that extend exposure and improve pharmacokinetics, receptor-Fc decoys that block pathogenic ligands, and toxin-Fc fusions engineered for targeted cell killing in oncology. By carefully selecting Fc isotypes and tailoring glycosylation, we align biologic activity with the therapeutic mechanism—whether it’s immune activation, neutralization, or extended circulation.
Albumin Fusions
Albumin is a natural serum carrier with an extended half-life due to FcRn recycling. We harness albumin as a fusion partner to enhance the pharmacokinetics of otherwise short-lived proteins, peptides, or antibody fragments. Albumin fusions not only prolong systemic exposure but can also be engineered for albumin receptor targeting, opening routes for tissue-specific delivery. Elise Biopharma provides both wild-type and engineered albumin variants, enabling clients to choose between native stability and advanced pharmacological tuning.
Minibodies & Compact Fusions
For therapeutic areas where tissue penetration is critical—such as oncology or neurobiology—we engineer compact formats like scFv-Fc fusions and peptide-Fc constructs. These “minibodies” combine the antigen specificity of scFvs or peptides with the stability, manufacturability, and effector functions of an Fc backbone. Compact fusion formats offer better tumor penetration, faster systemic clearance when desired, and flexible pairing options for bispecific or multispecific designs. Our team specializes in linker engineering, orientation control, and expression optimization to make these constructs manufacturable and stable under GMP conditions.
Multi-Domain Fusions
Next-generation therapies often demand more than one function in a single molecule. Elise engineers multi-domain fusion proteins incorporating tandem payloads, cleavable linkers, and dual-function domains. These include molecules that combine two cytokines in one Fc fusion, payloads that can be selectively released under tumor microenvironment conditions, or dual-targeting constructs that engage two distinct receptors simultaneously. By combining structural modeling with wet-lab validation, we ensure these complex architectures are not only innovative but also developable, stable, and scalable for clinical manufacturing.
Our Design Capabilities:
- Fc variant selection (IgG1, IgG2, IgG4, silenced Fc, Xtend)
- Linker optimization (rigid, flexible, protease-sensitive)
- Codon optimization and vector design
- Host cell selection: CHO, HEK, E. coli, Pichia pastoris
- Protein modeling to optimize orientation, glycosylation, and aggregation profile
In Silico & Wet Lab Developability Testing:
- Aggregation and viscosity prediction
- Disulfide bridge mapping and folding models
- Solubility and hydrophobicity screening
- Analytical validation (SEC-MALS, SPR/BLI, DSC, MS)
Bispecific Antibody & BiTE Development
Two Targets. One Molecule. Infinite Possibility.
Bispecific antibodies (bsAbs) and BiTEs are multi-functional proteins capable of engaging two distinct targets simultaneously. These formats power next-generation therapies in oncology, autoimmunity, and infectious disease.
Supported Formats:
- IgG-like bsAbs: Knobs-into-Holes, CrossMab, Duobody, DVD-Ig
- ScFv-based constructs: BiTEs (CD3 + tumor target), DART, TandAbs
- Fc-fused multispecifics (trispecifics, modular fusions)
- Heavy/light chain pairing control and asymmetric assembly
Bispecific-Specific Services:
- Dual-chain vector engineering and co-expression strategy
- Correct pairing control using electrostatics or sequence design
- ScFv linker tuning and co-transfection ratio optimization
- Advanced purification workflows for heterodimer selection
- Dual-potency testing: binding, cytotoxicity, and T-cell engagement
Analytical Readouts:
- Dual SPR/BLI binding curves
- Cell-based cytotoxicity and effector function (ADCC/CDC)
- SEC-MALS and ion-exchange for isoform separation
- Mispaired species detection and quantification
Cell Line & Process Development
From Design to Drug Substance—Under One Roof
Whether you start with a design or transfer in a reference molecule, Elise can own the full development lifecycle:
Cell Line Development
- Codon-optimized gene synthesis and cloning
- CHO and HEK cell line generation
- Single-cell clone isolation and titer screening
- Master Cell Bank (MCB) and Working Cell Bank (WCB) creation
Upstream Process Development
- Fed-batch and perfusion strategies
- High-yield media/feed optimization
- Scalable from 2 L to 2,000 L (single-use & stainless steel)
- Titer optimization and glycosylation control
Downstream Purification
- Protein A/G capture and viral inactivation
- Ion-exchange, HIC, SEC for polishing
- Bispecific-pairing-specific affinity workflows
- Endotoxin, HCP, and residual DNA clearance
Formulation & Fill-Finish
- Stability-optimized buffers (lyo or liquid)
- Vial and PFS aseptic fill/finish
- Real-time and accelerated ICH stability studies
Regulatory & CMC Support
No Surprises. No Delays. All the Way to IND.
- IND/BLA documentation for fusion and bispecific formats
- Regulatory consultation for FcRn, CD3, and multispecific risk areas
- Comparability studies for variant formats or formulation changes
- In-house QA/QC team with release testing support
Why Elise Biopharma?
✅ One Molecule, One Partner
From Fc-fusion design to bispecific GMP release, Elise supports your biologic at every stage—no need to hand off between CROs and CDMOs.
✅ Platform Expertise + Custom Flexibility
We’ve built platforms for Fc-fusions and bispecifics, but adapt every project to your construct’s unique challenges.
✅ Deep Analytical Insight
You don’t just get a protein—you get rich characterization data for every critical quality attribute (CQA), with regulatory-grade traceability.
✅ Speed Without Compromise
Feasibility results in 4–6 weeks. Pilot campaigns in <3 months. IND-readiness in under 12 months depending on program stage.
Partner With Us
Whether you’re advancing a next-generation BiTE, an extended half-life cytokine, or a dual-targeting therapeutic, Elise Biopharma brings the design insight, technical execution, and manufacturing power to get you there—on time, on spec, and ready to scale.