At Elise Biopharma, we understand that next-generation protein therapeutics—Fc-fusion proteins and bispecific antibodies—demand specialized expertise, robust processes, and unwavering quality. As your CDMO partner, we translate complex molecular designs into scalable, cGMP-compliant manufacturing pipelines, so you can focus on science and strategy while we deliver reliable, high-quality biologics.

Why Choose Elise Biopharma for Fc-Fusion & Bispecific Manufacturing?

• Deep Technical Expertise
  Our scientists combine decades of experience in mammalian cell line engineering, vector design, and process development to ensure your Fc-fusion or bispecific candidate meets target profiles for potency, stability, and manufacturability.
• Integrated “Gene-to-GMP” Workflow
  From vector construction to master cell bank (MCB) generation, analytical method qualification, and full-scale GMP production, our seamless process reduces handoffs and accelerates timelines.
• Flexible Capacity & Platforms
  • Single-Use Bioreactors (50 L–2,000 L) for rapid campaign turnaround
  • Stainless-Steel Suites (up to 10,000 L) for large-scale demand
  • Perfusion & Fed-Batch Options to optimize titer and product quality
• Regulatory & Quality Support
  Our in-house regulatory affairs team prepares IND/BLA-ready documentation, manages facility audits, and guides you through global submissions, ensuring full compliance with FDA, EMA, and ICH guidelines.
• Tailored Analytics & Characterization
  Comprehensive assays—mass spectrometry, glycan profiling, SEC-MALS, SPR/BLI binding kinetics, cell-based potency—validate every critical quality attribute (CQA) and support comparability studies.

Our Fc-Fusion CDMO Capabilities

1. Molecular & Vector Design
   • Fc variant selection (IgG1, IgG4, half-life mutants)
   • Linker optimization for stability and activity
   • Codon-optimized gene synthesis
2. Cell Line Development
   • CHO/HEK cell host selection
   • Single-cell cloning & stability screening
   • Master and working cell bank creation
3. Upstream Process Development
   • Media & feed strategy (chemically defined, host-specific)
   • DoE-driven optimization in microscale bioreactors
   • Scale-up to pilot and clinical manufacturing
4. Downstream Purification
   • Protein A capture & low-pH viral inactivation
   • Ion-exchange and mixed-mode polishing
   • Aggregate removal via size-exclusion or HIC
   • Endotoxin & host-cell protein clearance
5. Formulation & Fill-Finish
   • Buffer optimization for stability
   • Lyophilization or liquid fill-finish under aseptic conditions
   • Long-term stability studies

Our Bispecific Antibody CDMO Expertise

• Platform Technologies
  • Knobs-into-Holes, CrossMab, and Dual-Variable Domain formats
  • scFv-based BiTEs and DART scaffolds
• Chain-Pairing & Assembly
  • Heavy- and light-chain pairing strategies
  • Co-transfection optimization for correct heterodimer formation
• Expression Systems
  • Mammalian (CHO, HEK293) for full-length bispecifics
  • Microbial or yeast for fragment-based formats
• Specialized Purification
  • Affinity selections tuned for bispecific heterodimers
  • Advanced impurity removal to eliminate mispaired species
• Potency & Functional Assays
  • Dual-binding SPR/BLI analysis
  • Cell-based T-cell engagement and cytotoxicity assays
  • Fc effector function and ADCC reporter assays

How We Partner with You

1. Discovery & Feasibility
   You provide sequence and design goals; we deliver proof-of-concept expression data and preliminary analytics within 4–6 weeks.
2. Process Definition & Scale-Up
   Through iterative DoE studies, we lock in CPPs (pH, temperature shifts, feed profiles) and transfer processes to pilot scale, meeting your titer and quality targets.
3. cGMP Manufacturing & Release
   Production runs adhere to your specifications and global regulations. We handle lot release testing, release dossiers, and distribution logistics.
4. Regulatory Enablement
   Our regulatory team compiles CMC documentation, supports IND/BLA submissions, and liaises with health authorities to expedite approvals.
5. Post-Launch Support
   From process improvements to tech-transfer for commercial partners, we remain by your side—ensuring supply continuity and cost optimization.

Ready to Accelerate Your Program?

Partner with Elise Biopharma to leverage our world-class Fc-fusion and bispecific antibody CDMO services. Whether you’re in discovery or nearing commercial launch, our tailored solutions, cutting-edge platforms, and regulatory expertise will turn your complex biologic into a market-ready therapy—on time and on budget.

Contact Us Today! Let’s build the future of protein therapeutics—together.