Accelerating the next generation of biologic medicines
At Elise Biopharma, we offer comprehensive contract development and manufacturing (CDMO) services designed specifically for the complex and rapidly evolving field of therapeutic biologics. Our mission is to empower innovative biopharma companies, from emerging startups to established industry leaders, with the technical infrastructure and scientific partnership needed to bring life-changing therapeutics to market faster and more efficiently.
Whether you’re developing a targeted oncology biologic to engage immune checkpoints, an enzyme replacement therapy for a rare genetic disorder, or a next-generation mRNA vaccine platform with novel payloads, Elise delivers tailored solutions that match the unique demands of your program. From early-stage R&D support and cell line or strain development, through process optimization, scale-up, and full GMP manufacturing, we guide you every step of the way.
Our expertise spans across microbial expression systems (such as E. coli and Pichia pastoris), synthetic mRNA platforms, and hybrid manufacturing strategies that combine traditional and next-gen modalities. This cross-platform flexibility allows us to serve a broad range of therapeutic pipelines with unmatched speed, scientific depth, and technical agility. We help you navigate the entire development lifecycle—from preclinical studies and IND-enabling CMC packages to clinical trial material production and beyond—with quality, compliance, and commercial readiness always in focus.
At Elise, we believe that building successful therapeutics requires more than just technical capacity—it requires a collaborative mindset, proactive communication, and a commitment to solving complex challenges with creativity and precision. Our integrated teams work closely with yours to ensure your therapeutic program transitions smoothly from bench to bioreactor, and ultimately, to patients in need. With Elise Biopharma as your CDMO partner, you gain a scalable foundation that supports both scientific excellence and commercial success.
We Empower Therapies That Matter
Biologic therapeutics are redefining the way we treat disease—from precision oncology and rare genetic disorders to mRNA-based vaccines and regenerative medicine. These innovations hold immense promise, but bringing them to life demands more than just scientific brilliance. It requires a CDMO partner who can act quickly, manage complexity, and align seamlessly with regulatory and clinical development timelines. That’s exactly where Elise Biopharma thrives.
We understand that each therapeutic program has its own challenges—unique molecular structures, stringent quality requirements, and compressed development timelines. That’s why we offer tailored, end-to-end support that adapts to your needs and evolves as your program progresses. Whether you’re facing upstream expression hurdles, downstream purification issues, or formulation bottlenecks, our multidisciplinary teams bring deep technical knowledge and hands-on execution to solve them efficiently.
We proudly serve a wide range of innovators:
- Biopharma startups looking to accelerate their path to the clinic with rapid IND-enabling development, early-stage scale-up, and responsive project management
- Mid-sized biotech companies pushing the boundaries of novel biologics, such as cytokine mimetics, multispecific antibodies, or Fc-fusion constructs, who need a dependable CDMO to extend their internal capacity
- Large pharmaceutical organizations that are strategically outsourcing microbial fermentation, mRNA production, or niche expression challenges to streamline operations and improve cost-efficiency
- Academic institutions and translational research teams working on promising therapeutic candidates who need high-quality, GMP-grade materials for clinical studies, validation, or technology transfer
When you partner with Elise Biopharma, you’re not simply outsourcing manufacturing—you’re investing in a long-term, intelligent collaboration. We don’t just build systems; we help build therapies that save lives. With Elise, you gain a team that truly understands therapeutic value—and is ready to scale it with scientific rigor and commercial foresight.
Modalities We Support
We specialize in scalable, high-yield platforms optimized for the following therapeutic classes:
mRNA-Based Therapeutics
Our mRNA platform enables the rapid production of capped, high-integrity mRNA for both vaccines and non-vaccine therapeutics.
- Template synthesis and linearization
- Enzymatic IVT with CleanCap® or ARCA capping
- Enzyme-free purification and QC
- Scale-up from milligrams to multigrams
- Formulation support for lipid nanoparticle (LNP) encapsulation
Antibody Fragments & Bispecifics
Elise offers microbial expression systems for scalable, cost-effective production of antibody fragments (Fab, scFv) and bispecific constructs.
- E. coli or Pichia pastoris expression
- Solubility-enhancing tags and refolding optimization
- Endotoxin-controlled purification
- Multi-arm bispecific support
Fc-Fusion Proteins
Fc-fusion biologics are powerful therapeutic agents, but they require exacting expression and purification. We help you get there faster.
- Secreted expression in yeast or CHO (via partners)
- Glycoengineering consultation
- Fc-effector profiling
- Stability and bioassay development
Recombinant Cytokines
We offer high-purity cytokine manufacturing for immune therapies and biologic drug modulation.
- E. coli fermentation optimized for yield and solubility
- Refolding of inclusion bodies where needed
- High-throughput purification with low endotoxin
- Biological activity assays and bioanalytical support
Therapeutic Areas We Serve
We support a wide range of therapeutic indications, including:
- Oncology: Biologics for checkpoint inhibition, TME targeting, and immune engagement
- Rare Diseases: Recombinant enzymes, proteins, and gene therapy payloads
- Autoimmune & Inflammatory Disorders: Cytokine regulators and protein-based inhibitors
- Infectious Disease: mRNA and protein-based vaccine components
- Neurological Disorders: Novel biologics targeting neuroinflammation or CNS pathways
Our ability to quickly prototype, test, and scale makes us a natural fit for therapeutics where speed, customization, and quality are essential.
Process Expertise for Therapeutics
Our CDMO services cover the full development lifecycle:
Process Development
We provide upstream and downstream development, including:
- Strain or cell line development
- Fed-batch and continuous fermentation
- DSP purification optimization
- Process analytical tech (PAT) integration
Formulation & Fill-Finish
We work with clients and partners to support:
- Liquid, lyophilized, or nanoparticle formulations
- Small-scale sterile fill in vials or LNPs
- Stability studies and shelf-life design
Regulatory Support
Elise offers full support for:
- CMC section drafting
- IND/IMPD-enabling reports
- Batch records and method validation
- Quality-by-design (QbD) documentation
Why Therapeutic Companies Choose Elise
Clients choose us because we blend technical depth with entrepreneurial speed. We work as an extension of your team, guiding you through the complexity of biologics development with transparency and flexibility.
What makes us different?
- Agile timelines: We tailor development around your milestones
- Platform versatility: Microbial, mRNA, and hybrid workflows
- Tech-enabled insight: Smart data capture and in-line analytics
- Trusted quality: cGMP-compliant, ISO-certified, globally aligned
- Collaborative mindset: You’ll never feel like just a client
Proven Outcomes
- Increased titers 4x through fermentation optimization
- Reduced time to IND from 15 months to 9 months for a bispecific Fab project
- Supported a startup from lab-scale mRNA synthesis to LNP-ready GMP batches in under 6 months
Ready to Build What’s Next?
Whether you’re launching your first IND or scaling a platform biologic, Elise Biopharma is here to help you build faster, smarter, and with purpose.
Let’s talk!