Capabilities

A Quick-Look Guide to Everything Elise Biopharma Can Do for You

Below is a concise CDMO orientation to our three major capability families. Each section headline links to a deeper landing page; each bullet links to a full-length service brief.

Platforms & Modalities

Turnkey expression and manufacturing routes for every therapeutic format

• Microbial CDMO Services — High-titer E. coli and Pichia platforms that take enzymes, VLPs, and other recombinant proteins from 5 L feasibility to 2 000 L GMP with endotoxin routinely < 0.1 EU mg⁻¹.
• mRNA CDMO Services — Plasmid prep, linear-template IVT, capping, LNP formulation, sterile fill-finish, and release assays—all validated for vaccine or gene-editing payloads.
• Recombinant Proteins & Enzymes — Synthetic-biology strain design, AI-guided fed-batch control, and multimodal purification for therapeutic proteins and ISO 13485-grade diagnostic enzymes.
• Fc-Fusion & Bispecifics — End-to-end design and GMP manufacture of albumin-fusions, Fc-extended cytokines, dual-target IgGs, and T-cell–engaging BiTEs.
• Antibody Fragments & Nanobodies — scFv, Fab, diabody, and single-domain VHH production in secretion-tuned microbial hosts with rapid refold and polishing workflows.
• Cytokines & Growth Factors — Engineered cytokines and regenerative growth factors expressed at >10 g L⁻¹, refolded and purified for high potency and ultra-low endotoxin.
• Cell & Gene Therapy Services — GMP AAV/LVV vector suites, closed-system CAR-T/NK cell processing, and LN₂ logistics with full chain-of-identity documentation.
• Phage Therapeutics — End-to-end bacteriophage development, from host-range screening and lysogeny control to GMP fermentation, purification, and aseptic fill-finish. QC includes potency, genome stability, and endotoxin <0.1 EU mg⁻¹, with global regulatory dossier support.
• Phage-Derived Enzymes — High-yield microbial expression of recombinant lysins, depolymerases, and tailspike proteins in E. coli or Pichia, with advanced refolding, polishing, and stability workflows. ISO 13485- and GMP-grade enzymes delivered for human, veterinary, or diagnostic use.
• Oncolytic Viral CDMO Services —At Elise Biopharma, we provide comprehensive CDMO services for oncolytic viruses (OVs)—a rapidly expanding class of cancer therapeutics. Oncolytic viruses selectively infect and lyse tumor cells while stimulating systemic anti-tumor immunity, and they represent one of the most promising frontiers in immuno-oncology. We support development across major viral backbones, including vaccinia, herpes simplex virus (HSV), adenovirus, measles virus, and engineered novel platforms. Our infrastructure is designed to meet the technical and regulatory challenges of OV manufacturing: consistent amplification, genetic stability, tumor-selective potency, and compliance with oncology’s most demanding frameworks. Capabilities include cell line engineering, upstream amplification in single-use bioreactors, downstream purification via TFF and chromatography, and robust QC covering genetic stability, potency, infectivity, and safety. We also provide formulation and aseptic fill-finish, with cryopreservation and LN₂ logistics to support global trial deployment. Elise Biopharma offers seamless scale-up from 2 L to 2,000 L GMP manufacturing, validated scale-down models, and Stage 3 process validation to ensure clinical and commercial readiness. Our regulatory team supports IND, CTA, and BLA submissions across FDA, EMA, PMDA, and global agencies. Whether you are building a next-generation vaccinia armed with cytokines or a novel engineered adenovirus, Elise Biopharma provides the speed, rigor, and global readiness to accelerate your OV program into the clinic.
• Exosome CDMO Services —At Elise Biopharma, we deliver CDMO services for exosomes and extracellular vesicles (EVs)—an emerging modality transforming drug delivery, regenerative medicine, and oncology. Exosomes are natural nanocarriers secreted by cells, able to cross biological barriers, deliver RNA and protein payloads, and modulate immune responses. Their potential is vast, but so are the manufacturing and regulatory challenges. Our services span discovery to GMP supply, including upstream exosome production from MSCs, iPSCs, HEK293, CHO, or custom-engineered producer lines, all adapted to serum-free conditions. We support bioreactor-based production from 2 L to 2,000 L, ensuring scalability and reproducibility. Purification workflows include tangential-flow filtration, chromatography, and immunoaffinity capture, with proprietary polishing steps to remove protein aggregates, nucleic acids, and host contaminants. Our QC suite provides particle sizing (NTA, DLS), electron microscopy, surface marker profiling (CD63, CD81, CD9), RNA/protein cargo analysis, potency assays, and full sterility/endotoxin testing. Formulation options include liquid, lyophilized, and payload-loaded exosomes, with aseptic fill-finish into vials, syringes, or cartridges. We also offer regulatory dossier support, helping clients navigate evolving exosome frameworks across FDA, EMA, and PMDA. Elise Biopharma stands out with its integrated process development, GMP production, QC, and regulatory guidance, providing innovators with the infrastructure to accelerate exosome programs into clinical and commercial success.
• Bacteriocin CDMO Services — Bacteriocins are a diverse class of ribosomally synthesized antimicrobial peptides with growing applications in human therapeutics, microbiome modulation, veterinary medicine, and food safety. Unlike broad-spectrum antibiotics, bacteriocins are narrow-spectrum, highly potent, and often species-specific — making them valuable tools in the fight against antimicrobial resistance (AMR) and as precision microbiome modulators. At Elise Biopharma, we provide end-to-end bacteriocin CDMO services: strain engineering and pathway refactoring, high-density microbial fermentation, advanced downstream purification, and regulatory-grade QC. We support multiple bacteriocin classes, including lantibiotics, colicins, microcins, and engineered hybrids, with applications ranging from injectable anti-infectives to GRAS-certified food preservatives. Our GMP infrastructure covers formulation, aseptic fill-finish, and lyophilization, with full regulatory support for therapeutic, veterinary, and food use cases. Whether you’re developing a novel lantibiotic or scaling an engineered bacteriocin platform, Elise delivers precision, scalability, and regulatory readiness.
• Fungal Biologics — Development and scale-up of Trichoderma, Aspergillus, and other filamentous fungi for recombinant proteins, specialty enzymes, and secondary metabolites. Expertise includes strain engineering, high-density fermentation, and non-Newtonian DSP, with full QC of glycoforms, potency, and stability. GMP production and regulatory dossier support enable human, food, and industrial applications.
• Probiotics and Synbiotics —Elise Biopharma delivers end-to-end CDMO solutions for engineered probiotics and synbiotics—from strain design to GMP release and global distribution.
• Cell-Free Biomanufacturing — Elise Biopharma provides end-to-end CDMO services for cell-free systems (TX-TL, ribosome extracts, PURE platforms), enabling rapid DNA-to-protein prototyping without host-cell constraints. Capabilities include microbial and mammalian extract preparation, fed-batch energy regeneration, and lyophilized kit formats for distributed use. Full GMP scale-up (1 L–2,000 L), regulatory dossier support, and integrated QC/QA ensure cell-free solutions are deployable across therapeutics, diagnostics, food-tech, and defense applications.
• Nutraceutical Probiotic CDMO Services— At Elise Biopharma, we help nutraceutical brands turn GRAS probiotic strains like Lactobacillus plantarum and Bacillus coagulans into safe, stable products consumers can trust. From fermentation and purification to drying and encapsulation, we make sure probiotics stay alive and effective from factory to shelf. Our team also develops blends, synbiotics, and formats like capsules, stick packs, drinks, and powders. With quality testing, regulatory support, and GMP-aligned production, Elise delivers end-to-end probiotic CDMO services—helping you scale innovation into real consumer health products.
• ADC CDMO & Bioconjugate CDMO Services — Elise Biopharma turns unforgiving chemistry into clean filings with a true end-to-end platform. We supply/express the binder (CHO/HEK/VHH), synthesize and qualify linker–payloads (MMAE/MMAF, DM1/DM4, PBDs, duocarmycins, topoisomerase inhibitors, novel modalities), then run site-specific or stochastic conjugation (Sortase A, TGase, aldehyde-tag/oxime, UAA, glycan remodeling, re-bridging, maleimide) inside OEB-5 barrier isolators. Polishing and formulation tame hydrophobicity (PEG/spacers; liquid or lyo DP), and phase-appropriate release plus global dossier support carry you from IND to PPQ to commercial. Speed stays audit-ready: QbD, PAT, and digital-twin controls compress timelines while eBR/MES locks data integrity. Orthogonal analytics—HIC/native-MS DAR, peptide-mapping site localization, free drug/linker by UPLC-MS, SEC-MALS/CE-SDS, stability—de-risk comparability and approvals. Beyond classic cytotoxic ADCs, we build AOCs, protein/peptide conjugates, PEGylated polymers, and radioconjugate cold chemistry. One partner, all modalities—fewer surprises, more wins.
• LNP & Advanced Nanoparticles— Elise Biopharma designs and manufactures lipid nanoparticles, liposomes, solid-lipid/nanostructured carriers, lipid–polymer hybrids, dendrimers, and micelles for mRNA/saRNA/circRNA, siRNA/ASO, pDNA, CRISPR RNPs, proteins/peptides, and small molecules. We pair rational excipient selection (ionizable lipids by pKa/linker/tail architecture; DSPC/DOPE; cholesterol; PEG-lipid anchor/chain length) with closed, single-use microfluidic mixing that preserves FRR/TFR, solvent fraction, and temperature across scales. Orthogonal analytics—size/PDI and morphology, encapsulation, zeta potential, residual solvents, lipid composition, potency, sterility/endotoxin, and subvisible particles—tie CQAs to CPPs from development through GMP manufacturing, sterile fill–finish, and global logistics. Every program runs on a defined design space (DoE + PAT) so tech transfer reads like a control strategy, not lab notes. We tailor particles and presentations to route (IM/IV/SC/inhaled/ophthalmic/intratumoral), qualify frozen or refrigerated storage with clear freeze–thaw limits, and develop lyophilized formats that reconstitute without size creep or potency loss. Digital twins connect mixing levers to size, PDI, and encapsulation for defensible setpoints, while eBR/MES ensures data integrity—delivering fast, predictable, audit-ready scale-up and CMC answers that hold up in review.
• saRNA and circRNA Manufacturing— Elise Biopharma manufactures self-amplifying RNA (saRNA) and circular RNA (circRNA) end-to-end—template architecture, long-run IVT, high-efficiency circularization or replicon assembly, LNP encapsulation tuned to length/topology, sterile fill–finish, and GMP release. We engineer templates for translation and stability (UTRs/IRES/replicase cassettes), control fidelity and dsRNA during IVT with context-appropriate capping/tailing (saRNA) or cap-/poly(A)-free designs (circRNA), and validate circularity and integrity with orthogonal QC: RNase R challenge, long-read/nanopore mapping, advanced electrophoresis, residual DNA/enzymes, dsRNA assays, potency, sterility/endotoxin, and stability—packaged with phase-appropriate specs and dossier support. Scale-up is de-risked by a defined design space (DoE + PAT) and digital twins that link enzyme kinetics, impurity formation, and mixing to CQAs, then lock defensible setpoints for supplier/site/scale changes. Closed, single-use operations, eBR/MES data integrity, and comparability plans make tech transfer routine, while route-matched LNPs and qualified storage (frozen/refrigerated; lyophilized when required) keep timelines fast, predictable, and audit-ready from sequence to clinic.
• Radiopharmaceutical Services (Lu-177 / Ac-225) — Elise Biopharma is the radioligand & radioimmunoconjugate CDMO teams call when isotope supply is non-negotiable and the clock is ticking. We lock in Lu-177 (no-carrier-added and carrier-added) and Ac-225 through allocations/MOUs, run Annex 3–aligned hot labs with shielded isolators and manipulators, and keep everything under one roof—binder supply, chelator/linker chemistry, site-specific conjugation, hot labeling, purification, sterile DP formulation, QP release, and global delivery. One partner, one schedule, no drama. We make speed audit-ready: ALARA-by-design facilities, decay-aware GMP scheduling, and orthogonal QC (radiochemical purity by radio-HPLC/iTLC; radionuclidic purity by gamma spectrometry; molar activity; residual metals by ICP-MS; sterility/endotoxin). Digital twins and PAT compress development; eBR/MES preserves data integrity; theranostic pairing and dosimetry-ready releases mean clinics can dose on time. If you’re searching for best-in-class Lu-177 or Ac-225 CDMO support, this is the standard to beat.
• In Vitro Microbiology CDMO Services — Explore Elise Biopharma’s in vitro microbiology CDMO services: precision fermentation, AI-driven analytics, GMP-aligned data, and functional assays for probiotics, enzymes, and microbial therapeutics transforming biology into validated, manufacturable innovation.

Process Development & Manufacturing

From cell-line creation to qualified drug product—all under one roof

• Cell Line Development — Codon-optimised vectors, CRISPR site-specific integration, single-cell cloning, and cGMP master/working cell banks.
• Upstream Process Development — DoE-driven media/feed optimisation and digital-twin scale-up across 2 L–2 000 L batch, fed-batch, or perfusion.
• Downstream Purification — Platform and custom trains (Protein A/G/L, IEX, HIC, SEC, continuous PCC) with integrated viral clearance or endotoxin polishing.
• Formulation & Fill-Finish — Buffer/lyo design, high-concentration liquids, Grade A robotic isolators for vials, syringes, or cartridges, plus ICH stability.
• Process Characterization — CPP/CQA mapping, scale-down models, three-batch PPQ, and Stage 3 CPV dashboards for regulatory assurance.
• Contract Manufacturing — Clinical and commercial GMP slots with QP release, global logistics, and lifecycle cost-of-goods optimisation.
• Custom Bioprocessing — Bespoke unit-op combinations, unusual feedstocks, or hybrid microbial/mammalian flows engineered to fit non-standard molecules.

Advanced Services & Innovation

High-impact technologies that de-risk the toughest programs

• Precision Fermentation — CRISPR-edited microbes plus AI process control to produce animal-free proteins, specialty enzymes, and sustainable food ingredients at commercial scale.
• Glycoengineering — Host-cell glycosyltransferase editing and LC-MS fingerprinting to deliver bespoke fucosylation, sialylation, or bisecting GlcNAc profiles for biobetters.
• Analytical & QC — In-house HR-MS, SEC-MALS, SPR/BLI, cell-based potency, and ICH stability labs that shorten method-transfer times and generate dossier-ready data.
• Specialty & Emerging Modalities — Sandbox for bispecific T-cell engagers, nanobodies, scaffold proteins, and cell-free–expressed enzymes—rapid prototyping to GMP scale without extra tech-transfer steps.

Need more detail?

Email us at info@elisebiopharma.com—our scientific engagement team will map the fastest, lowest-risk path for your program.