Elise Biopharma is a specialized biopharmaceutical CDMO with dual hubs in Cambridge, Massachusetts, and Montréal, Canada—two of the world’s premier biotech innovation centers. We deliver end-to-end microbial biomanufacturing services focused on E. coli expression systems, precision fermentation, and custom bioprocess development. Backed by expert scientists and bioengineers, Elise combines deep technical expertise with operational agility to provide scalable, high-quality solutions for biologics, enzymes, proteins, and next-generation therapeutics.

Bioreactor

As a trusted E. coli CDMO partner, we support clients across the full development lifecycle—from early R&D and strain engineering to cGMP microbial fermentation, downstream purification, and analytical testing. Our facilities adhere to the highest standards of regulatory compliance and quality assurance, making us a reliable manufacturing partner for biotechs developing clinical or commercial-stage products.

At Elise, our mission is to empower innovation through collaborative, science-first partnerships. Whether you’re developing recombinant proteins, alternative proteins, or engineered biologics, we tailor our microbial fermentation services to fit your exact specifications and speed your time-to-market. With a passion for precision and a commitment to progress, Elise Biopharma is proud to enable the next wave of biomanufacturing breakthroughs—improving health outcomes and driving impact across healthcare, diagnostics, and industrial biotechnology.

Check out our services:

  • 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.
  • Bacteriocins — End-to-end lantibiotic, colicin, and engineered bacteriocin production, from strain design to GMP purification.
  • 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.
  • Exosome CDMO Services — Discovery-to-GMP production of exosomes/EVs from MSC, iPSC, CHO, or engineered producer lines. TFF and chromatography-based purification, particle QC (NTA, EM, flow cytometry), and aseptic fill-finish into vials or syringes. Regulatory dossier support included.
  • Probiotics & Synbiotics — End-to-end CDMO solutions for engineered probiotics and synbiotics: CRISPR strain engineering, anaerobic GMP fermentation, advanced encapsulation, and regulatory filings (GRAS, IND, IMPD) to bring living medicines to market.
  • Phage Therapeutics & Enzymes — Bacteriophage development from host-range screening to GMP fermentation, purification, and fill-finish. Recombinant lysins, depolymerases, and tailspike enzymes produced at ISO 13485 or GMP grade.
  • Oncolytic Viral CDMO Services — GMP development and manufacturing of vaccinia, HSV, adenovirus, measles, and novel engineered viral platforms. Capabilities include genetic stability QC, potency assays, scalable bioreactor runs, and regulatory submissions (IND, CTA, BLA).
  • Fungal Biologics — Development and scale-up of filamentous fungi (Aspergillus, Trichoderma) for recombinant proteins, enzymes, and metabolites. Expertise in non-Newtonian DSP, glycoform analysis, and GMP manufacturing.
  • 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.
  • 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.
  • 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.
  • 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.

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Email us directly at info@elisebiopharma.com