Microbial CDMO Services

Microbial Lab and pertri dish image, green, orange, white, blue gloves

Harness the power of microbes—and accelerate your project from idea to industrial reality. Whether you’re crafting milligram-scale therapeutic enzymes or scaling to metric-ton batches of precision-fermented proteins, our end-to-end microbial platform delivers:

  • Precision Strain Engineering
    AI-driven chassis design, tailored synthetic-biology hosts built around your molecule
  • Smart Bioreactors
    PAT-driven monitoring, inline Raman & off-gas MS, real-time control via PLC/SCADA 3.0
  • Seamless Downstream Processing
    Continuous purification trains—chromatography, TFF, sterile fill—without surprises

We deliver end-to-end fermentation process development—tailored to your Accelerate your microbial product from concept to commercial reality with our comprehensive fermentation process development—fully customizable to your molecule’s lifecycle and seamlessly scalable from bench‑top to production.

Our Core Offerings:

  • Host & Expression Platforms
    E. coli CDMO systems for high‑yield therapeutic proteins and GMP‑grade plasmid DNA.
  • Upstream Optimization
    Six Sigma and QbD‑driven DoE fermentation design to maximize titer, productivity, and robustness.
  • Critical Process Parameter Mapping
    FMEA‑based risk assessments identify and control the key variables—pH, DO, temperature, feed rate—for reliable scale‑up.
  • Scale‑Up & Scale‑Down Models
    Validated workflows from 1 L lab fermenters to 100 L pilot bioreactors, ensuring data‑driven consistency at every volume.
  • Advanced Control Strategies
    Real‑time PAT monitoring (inline Raman, off‑gas MS) coupled with automated feedback loops for precision fermentation services.
  • Cell Harvest & Lysis Optimization
    Side‑by‑side evaluation of mechanical disruption vs. chemical/enzymatic methods and tailored clarification trains.
  • Tech‑Transfer & Documentation
    Detailed scale‑down studies, regulatory‑ready batch records, and robust SOPs to guarantee a smooth hand‑off to your manufacturing site.

With Elise Biopharma’s bacterial CDMO expertise and end‑to‑end fermentation services, you’ll shorten development cycles, mitigate scale‑up risk, and achieve consistent, high‑quality yields—from milligrams to metric tons.

Expression Hosts We Can Tune to Your Molecule

Filamentous Fungi & Co-Cultures – Aspergillus and CRISPR-edited Clostridium for carbohydrases, secondary metabolites, bioplastics; engineered consortia for multi-step pathways

Link to our–> Fungi CDMO Services

Yeasts – Pichia for glyco-engineered biologics; Saccharomyces for food aromas & industrial enzymes; Hansenula/Kluyveromyces for dairy proteins & thermostable catalysts

Bacteria – E. coli for recombinant proteins & plasmid DNA; Bacillus for GRAS enzymes & spore probiotics; Corynebacterium/Streptomyces for vitamins, antibiotics, polyketides; facultative anaerobes for live biotherapeutics

Here is link to our Bacteria Fermentation Services

Please feel free to share your microbial inquiries and project proposals with us.

Fermentation Infrastructure & Digital Insight
TrainWorking VolumeTypical OutputKey Features
Discovery Pods2–10 L single-use (×12)120 DoE runs / monthInline Raman, auto-feed, off-gas MS
Pilot Suites20–100 L glass/stainless1–5 kg protein / batchBSL-2, ATF/TFF perfusion, sterile harvest
Clinical GMP300, 1 000, 3 000 L5–50 kg (Ph I–III)Class 10 000, segregated up/downstream
Commercial Trains5 000–14 500 L100 kg–metric tonRedundant utilities, aerobic/anaerobic lines, digital twin

All vessels run on PLC/SCADA 3.0 with cascading PID loops for pH/DO/antifoam, capacitance biomass probes, and cloud-based twins that predict k_La and heat loads before they happen. A 24∕7 command center of fermentation engineers and data scientists resolves deviations in hours, not days.

Downstream Purification & Finishing

High-pressure homogenization or bead-mill disruption feeds into disc-stack centrifuges, depth filters, and TFF cassettes. Multi-modal chromatography (IEX, mixed-mode, HIC, SEC) runs on single-use or stainless skids sized to match each batch. Final formats:

Aseptic ISO 5 isolators for robotic fill-finish and in-line weight checks

Bulk liquid, lyophilized cake, spray-dried powder, stabilized beadlets

Integrated Analytics & Quality Control

Cell Graphic, Blue pink

Online PAT data streams into our QC lab:

21 CFR Part 11 e-records and cloud-redundant batch archives

Instrumentation: UHPLC, LC-MS/MS, MALDI, CE-SDS, qPCR, validated ELISAs

Real-time dashboards for titer, purity, endotoxin, residual DNA, HCP

ICH Q1 stability chambers (–80 °C to +40 °C)

Engagement Models

  • Concept → IND Sprint
    Strain engineering, fed-batch/perfusion optimization, tox material & draft CMC in < 12 months
  • Scale-Up & Tech-Transfer
    Integrate your process into our 300–3 000 L suite; gap analysis & engineering batch in 30 days
  • Dedicated Capacity Lease
    Reserve a 5 000–14 500 L train for 6–36 months to secure launch volumes
  • Flexible Pilot Slots
    Monthly, pay-as-you-go 20–100 L runs for start-ups hitting investor milestones
Regulatory, Sustainability & Supply Assurance
  • Certifications: ISO 13485, ISO 9001, FDA-registered for IVD enzymes; full cGMP, CAPA, change-control
  • Data Integrity: 21 CFR Part 11 e-records, audit-ready archives
  • Green Footprint: 100 % renewable electricity by Q3 2025; closed-loop water & solvent recycling; biomass valorization
  • Resilient Supply: Multi-regional seed banks, dual-sourced critical raw materials, forward utility capacity
Your NeedElise Advantage
Rapid proof-of-concept120 parallel 2–10 L DoE fermentations per month = ranked strains in weeks.
Seamless scale-upDigital-twin, geometrically similar vessels reproduce yields from 2 L to 14 500 L.
Audit-ready clinical supplyISO-classified suites, Part 11 EBRs, and veteran QA keep inspections painless.
Cost-effective commercial lotsHigh-density fed-batch plus continuous DSP drive industry-leading COGS.
Long-term partnershipCapacity-lease model and tech-transfer toolkits protect IP, timelines, and margin.
Turn Microbial Potential into Market Reality

Whether you’re expressing a next-gen therapeutic enzyme, replacing animal-derived growth factors, manufacturing plasmid DNA, or producing fermented food proteins, Elise Biopharma delivers the microbial horsepower, regulatory rigor, and commercial mindset to succeed—first time, every time.

You can email our team directly at info@elisebiopharma.com

We look forward to speaking with you.