Enzyme CDMO Services

End-to-end development and GMP manufacturing of enzymes, master mixes, and specialty biocatalysts for therapeutics, diagnostics, and industrial biotechnology.

Elise Biopharma is a microbial-first, enzyme-native CDMO built to take you from gene to global supply—fast, reproducibly, and with the quality posture your regulators, payers, and customers expect. We manufacture across the full enzyme spectrum: recombinant research tools, clinical-diagnostic enzymes and master mixes (ISO 13485 / IVD), process-scale biocatalysts for pharma and green chemistry, phage-derived lysins and depolymerases, and niche enzymes for food, feed, veterinary, and environmental applications. If it’s an enzyme with economic value, we can discover it, evolve it, express it, purify it, formulate it, stabilise it, fill it, and ship it—under your brand, on your timeline, at the scale you need.

The fundamentals—what are enzymes, really?

Enzymes are nature’s precision machines: protein (and occasionally RNA) catalysts that accelerate chemical reactions by lowering activation energy and stabilising the transition state. Each enzyme carries an active site—a 3D pocket where substrates bind through complementary shape and charge. The choreography inside that pocket (hydrogen bonds, electrostatics, hydrophobic packing, metal coordination) guides the reaction along the lowest-energy path, often improving rates by factors of 10⁶–10¹² compared with uncatalysed chemistry.

A few ideas anchor how enzymes behave—and how we manufacture them well:

• Specificity and selectivity. Enzymes are famously choosy. Some recognise a single substrate; others accept families of analogues with different regio- or stereoselectivity. In diagnostics, that specificity underpins clean signal; in synthesis, it drives high ee and dr.
• Kinetics that matter. Practical performance is captured by kcat (turnover number) and Km (apparent affinity). Their ratio, kcat/Km, is a measure of catalytic efficiency. We characterise these under matrix-relevant conditions—not just ideal buffers—because blood, saliva, solvents, or slurries change the game.
• Cofactors and coenzymes. Many enzymes require metal ions (Mg²⁺, Zn²⁺, Fe²⁺/Fe³⁺) or organic cofactors (NAD(P)H, FAD, PLP, biotin). In biocatalysis we often implement cofactor-recycling modules (e.g., glucose or formate dehydrogenase) to keep reactions economical and green.
• Conditions define performance. Temperature and pH sculpt the active site. Too hot and proteins unfold; too acidic/alkaline and catalytic residues change protonation states. We map full pH–T landscapes and engineer variants or formulations that hold activity where you need it.
• Inhibition and robustness. Competitive inhibitors, salts, chaotropes, surfactants, and proteases all interfere in the wild. We quantify IC₅₀/Ki, engineer resistance through directed evolution or rational design, and buffer against interfaces and shear during processing and shipment.
• From sequence to substance. Making an enzyme at scale is its own discipline: expression host selection (E. coli, Pichia, Bacillus), high-cell-density fermentation, low-endotoxin downstream processing, and formulation science (buffers, excipients, redox control). For global logistics, we convert liquids into lyophilised or spray-dried formats with predictable reconstitution and shelf-life.
• Immobilisation for flow. In manufacturing, we frequently tether enzymes to carriers (silica, polymers, magnetic beads) using chemistries such as epoxy, aldehyde, or EDC/NHS. Immobilisation enables continuous flow, easier separation, and reuse cycles that improve cost per kilogram of product.
• Engineering for purpose. We reshape enzymes via site-directed mutagenesis, saturation mutagenesis, DNA shuffling, and AI-guided design to shift substrate scope, boost thermostability, or alter pH optima—always balancing activity with manufacturability and stability.

Understanding these fundamentals lets us design analytics that matter (not just a tidy gel), pick the right quality posture (RUO, ISO 13485, GMP-aligned, or GMP), and build processes that survive real-world conditions. In short, enzymes are exquisitely tuned molecular tools—and our craft is turning that molecular precision into reliable products that perform at bench, in clinic, and on the plant floor.

Why Elise for Enzymes

Microbial DNA—built for speed and precision.
Elise was engineered around microbial expression because it wins on time, tunability, and total cost of ownership for most enzyme classes. We architect programs in E. coli, Pichia pastoris, and Bacillus with the same scientific muscle you’d expect from a top-tier bioprocess lab: high-cell-density fermentation (HCDF) with DoE-driven feeds, kLa mapping to protect oxygen transfer at scale, and PAT (process analytical technology) to keep phenotypes in-spec.

Downstream, our endotoxin-aware DSP playbooks combine orthogonal captures (IMAC/AEX/HIC/SEC) with host-DNA clearance and low-shear UF/DF so you keep activity where it matters—after purification. Finally, we harden your product through formulation science: pH/ionic strength optimization, surfactant screening for interfacial stability, redox control for thiol chemistry, and lyo or spray-dry cycles tuned to your collapse temperature and reconstitution kinetics. The result: real-world stability without sacrificing catalytic performance.

Regulatory range—right-sized quality, zero waste.
Different markets demand different quality postures. We operate cleanly across RUO, GLP-grade, ISO 13485 (IVD), GMP-aligned, and full GMP when the program or geography requires it. Our teams translate your intended use into the appropriate package—design controls and risk files for IVD kits, validation master plans and method validations for regulated supply, or lean documentation for RUO/OEM reagents. You get exactly the quality you need to clear audits and move product—without gold-plating or hidden complexity.

Scale without drama—bench, pilot, production, repeat.
True scale-up preserves the physics that made your bench data sing. We protect mixing, mass transfer, and heat removal as volumes rise: bench (2–10 L), pilot (20–200 L), and routine production (500–2,000 L+) in-house, with qualified partners to 10,000–100,000 L when demand spikes. Our engineers hold kLa, impeller tip speed, gas hold-up, and feed kinetics inside validated envelopes so titer, purity, and critical quality attributes track development intent—not wishful thinking. Every transfer ships with a comparability dossier and a rollback plan.

Analytics that matter—performance over vanity metrics.
Purity is table stakes; performance closes markets. We write analytics around how your enzyme actually gets used: specific activity (U/mg) and kcat/Km under matrix-relevant conditions, thermal and pH windows mapped with dwell-time sensitivity, cofactor requirements and metal chelation response, inhibitor and solvent tolerance for biocatalysis, viscosity behavior for high-concentration fills, freeze–thaw and agitation robustness for logistics, and matrix compatibility for blood, saliva, wastewater, soil, or solvent systems. If a number moves your customer’s KPI, we measure, control, and lock it.

White-label and confidential—your brand, our backbone.
We operate as an invisible extension of your company. LIMS with role-based permissions, encrypted archives, and immutable audit trails keep IP walled and traceable. Workcells are compartmentalized physically and digitally; reports, CoAs, and labels carry your brand. Our fingerprints live only in the quality.

What Enzymes We Manufacture

Diagnostic enzymes & master mixes (ISO 13485 / IVD).
We design and manufacture complete molecular toolchains and OEM kits with clinical reliability: polymerases (Taq, hot-start, proofreading, high-fidelity, RT, one-step RT-qPCR), ligases, nicking endonucleases, reverse transcriptases for GC-rich targets, UDG/UNG carryover prevention, RNase inhibitors, and nuclease blends for sample prep. Formulations span liquid, concentrate, and true lyo-ready cakes that ship ambient and reconstitute cleanly. We tailor Mg²⁺/dNTP systems, fidelity vs. speed trade-offs, ROX/no-ROX options, and inhibitor resistance for blood, saliva, stool, and environmental matrices.

Clinical chemistry & specialty diagnostics.
We supply bulk and finished formats for analyzer reagents and OEM cartridges: Arylacylamidase (acetaminophen), β-Hydroxybutyrate dehydrogenase (ketone bodies), Salicylate hydroxylase, Uricase, Phenylalanine dehydrogenase, Diaphorase, plus custom panels. Each product ships with method files, activity specs, and stability protocols aligned to your instrument and geography.

Biocatalysts for pharma & green chemistry.
From grams to tons, we deliver free and immobilized enzymes that make chemistry cleaner and cheaper: transaminases, ketoreductases, imine reductases, nitrilases, halohydrin dehalogenases, lipases/esterases, and glycosyltransferases. We engineer solvent tolerance, water-activity windows, and cofactor recycling. For flow chemistry, we select carriers and coupling chemistries, qualify pressure drop and mass transfer, and validate reuse cycles so your economics pencil out in the plant—not just the poster.

Phage-derived enzymes.
Lysins, depolymerases, and tailspike proteins arrive with the purity profile these modalities demand: ultra-low endotoxin, verified host-DNA clearance by qPCR, and protease-aware formulations that retain activity in human matrices. We tune spectrum, resistance to proteolysis, and immunogenicity with sequence and formulation levers.

Emerging classes.
When your roadmap veers into the frontier, we bring it home: oligo-processing enzymes, restriction and nicking endonucleases, DNA repair tools, CRISPR effectors and accessory nucleases, RNA editors, carbohydrate-active enzyme suites (cellulases/hemicellulases), detergent-grade proteases, and orthogonal enzyme pairs for synthetic biology. If it’s novel but useful, we’ll make it manufacturable.

How We De-Risk Your Program

Design-of-Experiments from day one.
We don’t wander—We bracket the right variables early (induction regimen, temperature ramps, feed composition, pH/DO set-points, redox, antifoam strategy) and build response surfaces that predict behavior at scale. That shortens development and prevents “mystery” failures at 500 L.

Refolding when expression goes big and insoluble.
Inclusion bodies aren’t dead ends. Our refolding screens span denaturant gradients, redox couples, and dilution/in-column protocols; we qualify correct folding via activity, SEC-HPLC for aggregation, and orthogonal identity (MS/peptide mapping).

Endotoxin & host-DNA control built into DSP.
We integrate DNAse strategies, AEX polishing, and detergent-aware washes with lot-specific release testing (LAL and qPCR). Diagnostic and therapeutic tracks hit tighter thresholds without heroics at the end.

Formulation as a first-class citizen.
We map stability like we map titer—DoE for buffer/excipient systems, surfactants for interfacial stress, cofactor management, and chelation. For lyo, we design cake architecture, map collapse temperature, and set residual moisture specs that survive global shipping.

Documentation that travels.
RUO tech files, ISO 13485 design histories, or GMP-grade validation packages—each aligned to the markets you sell into. Auditors get what they need; your teams get exactly enough process detail to operate and scale.

Our Capabilities

• Expression & Strain Engineering: codon optimization, secretion signals, fusion tags, chaperone co-expression, periplasmic targeting, methanol-free Pichia strategies, CRISPR strain edits.
• Fermentation: HCDF >50–80 g/L DCW, kLa conservation, exhaust analytics, capacitance probes, perfusion with cell-retention when residence time matters.
• DSP: IMAC/AEX/CEX/HIC/SEC, low-shear TFF, automated column scouting, refolding platforms, nuclease treatment, orthogonal polish for aggregates and clipped species.
• Immobilization for Flow: epoxy/aldehyde/carbodiimide and ionic strategies on silica/polymer/magnetic supports; validated reuse cycles, cleaning, and pressure profiles.
• QC & Release: identity (LC–MS, peptide mapping), purity (SDS-PAGE, CE-SDS, SEC-HPLC), activity panels tailored to use-case, endotoxin (LAL), HCP ELISA, host-DNA qPCR, matrix interference studies.
• Stability: real-time/accelerated, freeze–thaw, agitation/thermal challenge, Arrhenius modeling, transport simulation, tropical profiles.
• Fill-Finish & Packaging: aseptic filling (vials/syringes/cartridges) in Grade A isolators, nitrogen overlays, lyo cycles, desiccant/OTR-optimized kits, white-label kitting with QR dashboards.
• Quality & Regulatory: RUO, ISO 13485/IVD, GMP-aligned/GMP; design controls, risk management (ISO 14971), validation master plans, method validation, change control.
• Security & White-Label: CDA-first, role-based LIMS, encrypted archives, immutable audit trails, compartmentalized workcells, your brand on every document.

Bottom line: Elise delivers enzyme programs that survive the journey—from clever sequence to commercial product—without drama. We optimize for performance, manufacturability, and regulatory credibility in equal measure, then disappear behind your label. If you’re ready to scale an enzyme that actually performs in the wild, we’re already set up to make it real.

The Elise Enzyme Pipeline — From Gene to Global Supply

1) Discovery & Design (or Tech Transfer)

• Sequence intake or de novo design. We start from your gene, literature mining, or proprietary libraries. Codon optimization and signal peptide selection accommodate host and secretion goals.
• In-silico pre-screening. Structure-/sequence-guided variant sets; AI-assisted stability and activity predictions; cofactor and pH landscape modeling to prioritize a tractable design space.
• IP-aware planning. We map freedom-to-operate and define variant libraries that avoid contested sequences while hitting performance targets.

2) Expression System Strategy

• E. coli (workhorse): T7/T5 systems, tight induction, tunable temperature, periplasmic or cytosolic expression, fusion tags for solubility, and refolding playbooks for inclusion bodies.
• Pichia pastoris (secreted & glyco-aware): AOX1/GAP promoters, methanol or methanol-free strategies, secretion optimization, and glycan control for specific activity or immunogenicity needs.
• Bacillus (secretion & spore-compatible): GRAS/QPS contexts for food/feed, extracellular enzyme titers, and robust downstream flows without endotoxin baggage.

3) Fermentation Development

• High-cell-density fermentation (HCDF): DoE-driven feed, pH, temperature, and dissolved oxygen profiles; antifoam control; redox and exhaust analytics for reproducible expression windows.
• Perfusion & continuous options: For labile enzymes or programs that need steady-state output and tight residence-time distributions.
• Containment and safety: ATEX/NFPA compliance for solvents; OEB assessments for special hazard classes; environmental monitoring and validated kill steps.

4) Downstream Processing (DSP)

• Capture: IMAC, ion exchange (AEX/CEX), hydrophobic interaction (HIC), mixed-mode resins, or affinity ligands; predictable step yields; low-shear unit operations for fragile proteins.
• Refolding (when needed): Screened denaturants, redox systems, and refolding gradients; inline dilution; diafiltration into stabilization buffers with precise redox potential.
• Polish: SEC or orthogonal polish to remove aggregates, clipped species, and host-cell proteins (HCP).
• Endotoxin & host-DNA control: Multi-pass AEX, phase-compatible washes, enzymatic DNA removal, and qPCR-verified clearance to meet stringent IVD or therapeutic thresholds.
• Concentration & exchange: TFF/UF-DF with MWCO matched to quaternary structure; recovery modeling to avoid interfacial denaturation.

5) Formulation & Stabilization

• Solution stability: pH and ionic strength mapping; cofactor and metal chelation control; surfactants for interfacial protection; reducing systems for thiol management.
• Lyophilization (ready for global supply): Cake architecture design, collapse temperature mapping, excipient matrices (sugars, polyols, amino acids), residual moisture spec, reconstitution kinetics.
• Spray-drying & spray-freeze drying: For enzymes compatible with rapid particle engineering; nitrogen atmospheres; microencapsulation for GI transit or solvent exposure.
• Immobilization: Covalent and adsorptive immobilization on tailored carriers for flow chemistry; activity-per-gram and reuse cycles validated under customer conditions.
• Master mixes: Hot-start chemistries, UNG/UDG carryover prevention, low-ROX/Hi-ROX options, inhibitor-resistant formulations (blood, saliva, soil), and lyo-ready mixes for ambient logistics.

6) Fill-Finish & Packaging

• Aseptic filling: Vials, prefilled syringes, and cartridges in Grade A isolators; low-shear pumps; nitrogen overlay; sterile filtration with integrity testing.
• Kitting & white-label: OEM kits with your artwork, QR-code dashboards, barcoded traceability, and region-specific IFUs.
• Cold-chain and ambient: Frozen, refrigerated, or true ambient logistics for field-deployable diagnostics; validated shippers; LN₂ partnerships for ultra-cold when needed.

7) Quality, Release, and Documentation

• Analytics that match use-case:
  • Identity: intact mass by LC–MS, peptide mapping, glycan profiling (where relevant).
  • Purity: SDS-PAGE, SEC-HPLC, CE-SDS, HCP ELISA, host-DNA qPCR, endotoxin (LAL/kinetic chromogenic).
  • Activity: tailored functional assays (specific activity, kcat/Km, temperature and pH profiles, inhibitor sensitivity, organic solvent tolerance).
  • Stability: real-time and accelerated, freeze–thaw cycling, agitation and thermal challenge, Arrhenius modeling.
• Certificates & files: CoA, CoO, batch records, validation reports, method files, and stability protocols aligned to RUO/IVD/GMP expectations.
• Digital traceability: LIMS with role-based access, immutable audit trails, and exportable e-records for your QMS.

Service Tiers & Regulatory Framework

• RUO / Non-GMP: Rapid prototyping, feasibility, library screens, and early benchmarking.
• ISO 13485 / IVD: Documented design controls, risk management (ISO 14971), and process validation suitable for clinical diagnostic kits and OEM supply.
• GMP-aligned / GMP: For therapeutic, veterinary, or combination products that demand GMP manufacturing and CMC-style packages.

We align quality depth with your market and budget—no overkill, no shortcuts.

Advanced CDMO Capabilities

Directed Evolution & Smart Library Engineering

At Elise Biopharma, enzyme evolution isn’t a buzzword—it’s a data-driven science of precision. We integrate directed evolution and AI-guided mutagenesis into a continuous design–build–test–learn cycle that compresses months of empirical screening into predictive, quantifiable iterations.

Our enzyme CDMO platform employs saturation mutagenesis focused on catalytic residues, substrate-binding pockets, and flexible loop domains, while DNA shuffling and in silico recombination expand the sequence landscape without compromising structural integrity. AI-based substitution models score and prioritise amino acid replacements based on three-dimensional conformational tolerance, ensuring that stability and function co-evolve rather than conflict.

In the screening phase, we deploy high-throughput microtiter and microfluidic systems with kinetic readouts capable of detecting subtle improvements in kcat/Km under complex matrix conditions. When scale requires deeper granularity, fluorescence-activated cell sorting (FACS) enables phenotype sorting within display systems—yeast, ribosome, or phage—each chosen according to the physicochemical behaviour of the enzyme class.

Down-selection uses multi-objective scoring matrices that incorporate activity, thermostability, solvent and salt tolerance, inhibitor resistance, and formulation compatibility. This holistic scoring ensures that enzyme variants not only perform under laboratory conditions but also thrive in the harsh realities of industrial and diagnostic environments.

Where many enzyme manufacturers halt at improved kinetics, Elise Biopharma continues into process integration—modelling how evolved variants behave in fermentation and downstream purification to ensure true manufacturability.

Process Intensification & Continuous Perfusion Bioprocessing

Enzyme productivity is not merely measured by titres; it’s defined by space–time yield and cost per catalytic unit. Elise’s bioprocess engineers use perfusion and intensified fed-batch strategies to sustain high-cell-density cultures with consistent oxygenation, nutrient balance, and waste removal.

In contrast to classical batch processes, perfusion allows continuous harvest while maintaining exponential-phase cells, enabling enzyme manufacturing that achieves steady-state productivity. By coupling PAT (Process Analytical Technology) sensors with model predictive control, we minimise dead time and maintain culture viability, which directly translates into shorter campaign durations and maximised fermentor utilisation.

Our enzyme CDMO operations are designed for minimal downtime—integrating in-line sterilisation, real-time viscosity monitoring, and automated feed control. This high-resolution control architecture allows us to produce enzymes with reproducible post-translational modifications and predictable folding patterns, critical for maintaining activity across lots and scales.

Low-Endotoxin & Ultra-Clean Downstream Processing

For diagnostic and therapeutic enzyme programs, purity is existential. Elise Biopharma’s low-endotoxin DSP pipelines routinely achieve endotoxin levels below 0.05 EU/mg—surpassing conventional IVD-grade baselines. Host-cell DNA clearance is verified via quantitative PCR, and we apply orthogonal clearance steps—anion-exchange, nuclease treatment, and tangential-flow filtration—to guarantee compliance with even the most stringent regulatory frameworks.

Each enzyme undergoes sterility, bioburden, and mycoplasma testing aligned with your product’s classification: RUO, ISO 13485, or GMP. Our downstream strategy is modular, enabling rapid reconfiguration between enzyme classes while maintaining segregation integrity and full audit trail traceability.

Immobilised Enzymes for Flow Chemistry

When static catalysis meets dynamic systems, immobilised enzyme technology bridges the gap. Elise Biopharma’s enzyme CDMO platform develops immobilised catalysts for flow reactors where precision, stability, and reuse economics dominate the equation.

We select carriers—silica, methacrylate polymers, or magnetic nanocomposites—based on your process solvent, pH, ionic strength, and pressure profile. Coupling chemistries (epoxy, aldehyde, carbodiimide, and ionic adsorption) are screened through automated microreactor assays that evaluate activity retention, mass-transfer limitations, and enzyme leaching.

Each immobilisation configuration is modelled computationally for pressure drop, thermal stability, and catalytic lifetime. Reuse cycles are validated under your specific operating environment—solvent systems, reaction temperatures, and cleaning agents—to establish reliable turnover metrics and robust cost-of-goods forecasts.

Lyo-Ready and Ambient-Stable Master Mixes

In diagnostics, robustness is synonymous with reliability. Elise Biopharma’s lyophilisation-ready enzyme formulations are engineered to withstand global distribution and field deployment without cold-chain dependence. We optimise excipient matrices—trehalose, mannitol, PEG derivatives, and amino acid stabilisers—to achieve rapid reconstitution kinetics while preserving activity post-lyo.

Our ambient-stable master mixes maintain qPCR efficiency, fidelity, and inhibitor resistance even under elevated temperature cycles, enabling on-site testing for point-of-care and low-infrastructure laboratories. Each formulation undergoes accelerated stability testing (ICH Q1A) and real-time validation across humidity and temperature gradients to guarantee shelf-life and performance equivalence after rehydration.

Phage-Derived Enzymes

Beyond conventional biocatalysts, Elise Biopharma develops phage-derived enzymes—lytic proteins and depolymerases designed for therapeutic and industrial applications. We specialise in human-compatible formulations exhibiting activity in complex biological matrices, protease resistance, and extremely low endotoxin profiles.

Host-nucleic-acid removal is verified through qPCR, while sequence-stability testing ensures batch-to-batch genetic fidelity. These therapeutic-grade enzymes are ideal for compassionate-use programs, early clinical trials, and veterinary or agricultural applications where conventional antibiotics fail.

Market-Specific Solutions

Clinical Diagnostics & IVD

Our enzyme CDMO workflows for clinical diagnostics adhere to ISO 13485 and encompass full Design History Files (DHFs), risk assessments, and traceability systems. We support OEM and white-label enzyme manufacturing—your bottle, your label, your lot coding—while ensuring exact reproducibility across lots.

Shelf-life confidence is built through real-time and accelerated stability studies compliant with ICH and WHO climatic zones, enabling global shelf-life claims, including tropical stability where required.

Pharmaceutical & Biocatalysis Applications

In small-molecule synthesis, our enzyme manufacturing extends into chemo-enzymatic cascades featuring enantioselective transaminases, imine reductases, and nitrilases optimised for industrial flow systems. We integrate cofactor regeneration (NADH/NADPH) and solvent-engineering modules to enhance yield and optical purity.

For process intensification, we offer seamless tech transfer from batch to flow reactors, complete with immobilisation strategies, cleaning validation, and mass-transfer modelling. Every biocatalytic enzyme we deliver is qualified for both regulatory and commercial readiness.

Research Tools & Synthetic Biology

We manufacture and QC novel enzymes for synthetic biology, genome editing, and molecular cloning, including orthogonal nucleases, bespoke polymerases, nickases, repair enzymes, and CRISPR-associated proteins. Each reagent is tailored for high reproducibility, low background, and application-specific fidelity—far beyond generic “purity” standards.

Elise also offers custom white-label reagent kits—cloning, RT-qPCR, CRISPR support, and field-deployable molecular assays—produced under your brand and backed by our manufacturing assurance.

Food, Feed, and Industrial Bioprocesses

For food and feed industries, Elise Biopharma manufactures GRAS and QPS-qualified enzyme systems compliant with FAMI-QS and EFSA documentation frameworks. Our enzyme CDMO capabilities extend to detergent proteases, starch-modifying enzymes, flavour precursors, and microencapsulated enzyme blends resistant to thermal and mechanical stress.

Spray-drying, encapsulation, and extrusion technologies are applied to produce stable enzyme granulates for detergents and specialty food formulations that endure aggressive industrial conditions without activity loss.

Example Engagement Models

Gene-to-Bottle (6–9 months):
Full-cycle enzyme development encompassing design, expression screening, high-cell-density fermentation, downstream process lock, formulation and lyophilisation, validation, and tech-file transfer to routine supply.

Scale & Stabilise (3–6 months):
For existing enzymes requiring optimisation—our scientists improve titres, reduce cost-of-goods, eliminate endotoxin and host impurities, and deliver ready-to-market lyophilised or ambient-stable formats.

OEM Master Mix (8–12 weeks):
We customise polymerase systems to your assay matrix, develop robust lyophilised cakes, and provide white-label kits with full documentation and stability validation.

Biocatalyst in Flow (12–20 weeks):
Our enzyme CDMO experts immobilise your enzyme, qualify pressure and activity profiles under target solvent systems, and document reuse cycles, cleaning validation, and operational economics.

Data Integrity, Security, and White-Label Discipline

Every project begins under CDA—confidentiality before curiosity. Elise Biopharma enforces role-based access within its LIMS, electronic signatures, immutable audit logs, and full version control of analytical and manufacturing methods.

Physical and digital compartmentalisation safeguards multi-client security. Our philosophy is elegantly simple: your brand leads, your IP remains sovereign, and Elise’s presence is visible only through quality, consistency, and technical mastery.

Top 25 Enzyme CDMO FAQ: Everything You Wanted to Know About Custom Enzyme Manufacturing

1. Do you manufacture both recombinant and native enzymes?

Yes. Elise Biopharma specialises in recombinant enzyme manufacturing using E. coli, Pichia pastoris, and Bacillus subtilis, while also offering extraction and purification of native enzymes from microbial or plant hosts. Recombinant systems deliver scalability, traceability, and lower endotoxin risk; native enzymes remain ideal when complex cofactors or glycosylation patterns are required.

2. Which microbial systems do you use for enzyme production?

Our microbial fermentation platforms span E. coli for cytosolic expression, Pichia pastoris for secreted glycoproteins, and Bacillus for robust extracellular enzymes. Each host is backed by strain-engineering toolkits—codon optimisation, signal peptide tuning, CRISPR knockouts for protease control, and automated clone selection using optical density and activity metrics.

3. Can you develop diagnostic enzymes for clinical chemistry and IVD applications?

Absolutely. We manufacture ISO 13485-compliant diagnostic enzymes such as Arylacylamidase, β-Hydroxybutyrate Dehydrogenase, Salicylate Hydroxylase, Uricase, and Phenylalanine Dehydrogenase. Each product undergoes full method validation, real-time stability studies, and lyophilisation testing for inclusion in analyser reagents and OEM diagnostic kits.

4. Do you produce polymerases and master mixes for PCR and qPCR?

Yes—polymerases, ligases, nicking enzymes, and reverse transcriptases are part of our molecular biology enzyme CDMO portfolio. We formulate high-fidelity, hot-start, and one-step RT-qPCR master mixes that are lyo-ready and ambient-stable, ensuring reproducibility in clinical and research settings.

5. How do you control endotoxin and host-DNA contamination?

Low-endotoxin purification is a signature strength. We deploy orthogonal DSP strategies—AEX chromatography, nuclease digestion, and ultrafiltration—to achieve < 0.05 EU mg⁻¹ and < 10 pg DNA mg⁻¹ benchmarks. Every batch undergoes qPCR verification and LAL testing, enabling supply into both IVD and therapeutic enzyme markets.

6. Do you support enzymes for industrial biocatalysis and green chemistry?

Yes. Our biocatalyst manufacturing platform delivers transaminases, imine reductases, nitrilases, halohydrin dehalogenases, lipases, and glycosyltransferases for small-molecule synthesis. We tailor cofactor recycling (NADH/NADPH), solvent tolerance, and water-activity parameters to match continuous or batch reactor conditions—reducing cost-of-goods while maximising turnover frequency.

7. Can you supply immobilised enzymes for flow-chemistry systems?

Indeed. We immobilise enzymes on silica, methacrylate, or magnetic supports via epoxy, aldehyde, or carbodiimide coupling. Each immobilisation chemistry is validated for pressure drop, diffusion limits, and reuse lifetime. Clients receive a full flow-reactor dossier including turnover metrics and validated cleaning protocols.

8. Do you provide enzyme formulation and stabilisation services?

Yes—formulation is integral to our enzyme development pipeline. We conduct DoE-based optimisation of buffer systems, surfactants, polyols, and amino-acid stabilisers. We simulate freeze–thaw, agitation, and humidity stress to define shelf-life. Our lyo cakes retain activity for > 24 months under ambient conditions.

9. Can Elise Biopharma help transition an academic enzyme into GMP manufacture?

Precisely. We perform scale-up translation from 250 mL bench to 2,000 L GMP reactors, mapping kLa, agitation, feed profiles, and oxygen mass-transfer coefficients. Process comparability dossiers confirm equivalence in purity, activity, and CQAs, ensuring a smooth regulatory transition.

10. Do you develop phage-derived enzymes such as lysins or depolymerases?

Yes. We produce phage-derived enzymes—endolysins, depolymerases, and tailspike proteins—under ultra-clean microbial expression systems. These therapeutic proteins feature validated protease resistance, host-DNA removal, and sub-endotoxin purity, enabling use in compassionate-use and veterinary antimicrobial programmes.

11. Can you design enzymes for CRISPR, cloning, or synthetic biology kits?

Indeed. We engineer orthogonal nucleases, nickases, and polymerases for CRISPR editing, DNA repair, and cloning workflows. Each reagent undergoes fidelity testing, off-target cleavage analysis, and activity profiling across ionic and temperature gradients—ideal for custom reagent brands and white-label kit developers.

12. Do you manufacture enzymes for food, feed, and detergent industries?

Yes. Elise Biopharma supplies industrial enzymes compliant with GRAS/QPS and FAMI-QS documentation. We produce proteases, amylases, cellulases, and lipases for detergents and feed, plus encapsulated blends for harsh pH or high-temperature environments. Spray-drying and microencapsulation ensure survivability and uniform dosing.

13. How do you approach enzyme refolding from inclusion bodies?

Insoluble expression isn’t the end. We run parallel refolding screens across denaturant gradients, redox couples, and dilution/in-column strategies. Activity assays, SEC-HPLC, and mass spectrometry verify correct tertiary structure, while analytics capture aggregation, clipping, and disulfide integrity.

14. What analytical techniques ensure enzyme quality and consistency?

Our QC framework integrates LC–MS, peptide mapping, CE-SDS, SEC-HPLC, and circular dichroism to monitor identity, purity, and folding. Activity assays are matrix-specific—measuring catalytic efficiency in the actual assay or solvent system rather than idealised buffers.

15. Can you produce enzymes with tailored kinetic or pH profiles?

Yes. Using rational design and directed evolution, we shift optimal pH and temperature ranges or alter cofactor dependency. Computational enzyme modelling predicts mutations that tune active-site electrostatics, allowing clients to fit enzymes into their proprietary reaction conditions without compromise.

16. Do you offer lyophilisation and packaging for finished enzyme kits?

Yes—we offer aseptic fill-finish and lyophilisation services for diagnostic and molecular kits. Our controlled lyo chambers ensure uniform cake morphology and residual-moisture profiles < 1%. We package in foil, HDPE, or nitrogen-flushed vials, providing ready-to-ship white-label kits.

17. How do you ensure data integrity and confidentiality?

Every project begins under CDA. Our LIMS includes role-based permissions, encrypted storage, immutable audit trails, and versioned methods. Workcells are compartmentalised physically and digitally, making Elise Biopharma the most trusted enzyme CDMO for confidential collaborations.

18. Do you support enzyme engineering for solvent-free or low-water systems?

Yes. We specialise in solvent-adapted enzymes for organic synthesis. Through adaptive evolution and structure-guided mutagenesis, we generate variants that remain active in DMF, DMSO, or ionic liquids. Activity retention and conformational stability are quantified by microcalorimetry and dynamic light scattering.

19. Can you co-develop enzymes for biosensor or diagnostic device integration?

Indeed. We partner with medical-device firms to integrate biosensing enzymes—oxidases, dehydrogenases, and peroxidases—onto electrochemical or optical surfaces. We validate immobilisation chemistry, diffusion rates, and signal-to-noise ratios, providing pre-qualified enzymes ready for device assembly.

20. Do you provide stability studies for global market registration?

Yes. Our stability programmes follow ICH Q1A guidelines with accelerated, intermediate, and real-time testing under multiple humidity and temperature zones. We model degradation kinetics (Arrhenius, Weibull) and generate datasets suitable for FDA, EMA, and PMDA submissions.

21. What scales of enzyme manufacturing do you support?

We offer a true continuum: bench (2–10 L), pilot (20–200 L), GMP production (500–2,000 L), and partnered expansion to 100,000 L. Oxygen-transfer coefficients, mixing times, and shear profiles are conserved across scales, ensuring identical enzyme performance from feasibility lot to commercial run.

22. Do you provide custom analytics for activity and inhibition studies?

Yes. We design bespoke kinetic assays using spectrophotometric, fluorometric, or coupled-reaction methods. We map Michaelis–Menten constants, inhibition constants, and temperature coefficients. For IVD enzymes, we calibrate activity in clinical matrices—serum, urine, or saliva—rather than artificial substrates.

23. Can Elise Biopharma manufacture cofactor-dependent enzyme systems?

Absolutely. We produce flavo-, metallo-, and pyridoxal-dependent enzymes, supplying their cofactors in optimised molar ratios. For continuous synthesis, we integrate cofactor-recycling enzymes like glucose dehydrogenase or formate dehydrogenase to maintain redox balance and reduce consumable costs.

24. Do you provide regulatory and documentation support for enzyme registration?

Yes. We prepare CMC-style dossiers, validation master plans, risk analyses, and ISO 13485 technical files. Our regulatory team supports submissions under FDA CBER, EMA, EFSA, and VICH frameworks, aligning documentation to therapeutic, diagnostic, or industrial enzyme pathways.

25. Why choose Elise Biopharma as your enzyme CDMO partner?

Because we combine microbial precision, analytical sophistication, and white-label discretion in one integrated ecosystem. Whether you’re launching a diagnostic assay, scaling a biocatalyst, or pioneering a new phage enzyme class, Elise Biopharma delivers scalability, regulatory readiness, and scientific depth that others simply cannot.

What Sets Elise Apart

Speed—without shortcuts.
We move programmes from sequence to supply with uncommon velocity because we’ve already done the hard thinking. Design-of-Experiments (DoE) narrows the field quickly; proven playbooks prevent “re-invent the wheel” detours; and PAT-driven controls keep bioreactors on song. You get first-pass success at bench, then the same behaviour at 20 L, 200 L and 2,000 L—no drama, no mystery scale effects.

Performance-centric QC, not vanity metrics.
Anyone can show a pretty gel. We measure what wins markets: kcat/Km in your matrix, pH/temperature dwell tolerance, inhibitor and solvent robustness, freeze–thaw recovery, and viscosity at fill strength. If a parameter moves your customer’s KPI, we lock it—and we release lots against it.

Formulation that survives the real world.
Our lyophilised cakes reconstitute fast and predictably; our ambient-stable and spray-dried formats endure warm warehouses, bumpy logistics and impatient users. We engineer excipient systems to protect activity at interfaces, through agitation, and across humidity cycles—because a brilliant enzyme that dies in transit isn’t a product.

Costs engineered, not hoped for.
We track productivity per fermentor-day, yield per litre of resin, activity-per-dollar, and true space–time yield. That discipline trims COGS without trimming quality, so your RUO kit, IVD, or biocatalyst stays competitive at launch and remains profitable at scale.

Regulatory depth on tap.
RUO, ISO 13485 (IVD), GMP-aligned or full GMP—we right-size documentation, validations and change control to your market. Auditors get what they need; you don’t pay for quality theatre.

Security and white-label discipline.
CDA first, always. Role-based LIMS, encrypted archives and immutable audit trails keep IP walled. Your brand sits on every CoA, label and kit; our fingerprints live only in the consistency.

Partnership over posturing.
We’re the quiet power behind your label—answering the awkward technical questions, troubleshooting edge-case failures at 2 a.m., and shipping lots that pass the sniff test the first time. We obsess over your KPIs, not our headlines: fixing viscosity at fill strength, flattening ΔCq drift, squeezing another 10% yield out of a stubborn column, and documenting it so QA nods instead of frowns. The work isn’t glamorous; it’s disciplined, measurable, and relentlessly on time. Your success is our reputation, and we protect it by doing the unshowy things brilliantly, over and over.

North American roots, global reach.
Elise Biopharma is an enzyme CDMO anchored in Cambridge, Massachusetts and Montréal, Canada—two powerhouse ecosystems for microbial engineering, diagnostics, and biocatalysis. Cambridge gives you rapid access to innovators, instrument vendors, and clinical collaborators; Montréal adds deep bioprocess talent, bilingual regulatory fluency, and cost-efficient scale. Together, the corridor lets us run follow-the-sun development, vendor-qualified supply chains, and audit-ready documentation across U.S. and Canadian expectations—so your programme moves faster without cutting corners.

Bottom line.
Elise Biopharma isn’t just another enzyme CDMO. We fuse microbial precision, industrial pragmatism, and regulatory literacy into a single machine that turns clever sequences into reliable, scalable, profitable products—diagnostic enzymes, master mixes, and hard-working biocatalysts that actually perform in the wild. That’s why clients stay, why auditors sign off, and why your enzymes win.

Contact our team today at info@elisebiopharma.com