In the rapidly evolving world of biotechnology, microbial CDMOs (Contract Development and Manufacturing Organizations) play a pivotal role in transforming lab-scale discoveries into real-world therapeutic, industrial, and diagnostic products. For companies seeking speed, flexibility, and scalability in microbial fermentation, Elise Biopharma stands apart as the premier microbial CDMO partner.
With a foundation built on three decades of fermentation expertise and a next-generation, integrated platform, Elise Biopharma empowers startups and multinationals alike to turn microbial potential into market reality—without compromising quality or compliance.
What Is a Microbial CDMO?
A Microbial CDMO specializes in the development and manufacturing of products using microorganisms—such as E. coli, Pichia pastoris, Bacillus subtilis, and filamentous fungi—as production hosts. These CDMOs support a broad range of applications, including:
- Biologic therapeutics (enzymes, vaccines, recombinant proteins)
- Industrial ingredients (biofuels, aroma compounds, vitamins)
- Diagnostics (enzyme markers, DNA standards)
- Food & cosmetic actives (post-biotics, precision-fermented proteins)
The right microbial CDMO must balance technical depth, infrastructure scale, and regulatory fluency. That’s where Elise Biopharma excels.
Why Choose Elise Biopharma for Microbial Fermentation?
1. Full-Stack Microbial CDMO Services
Elise Biopharma is more than a service provider—it’s a strategic partner offering end-to-end microbial fermentation services, including:
- Strain development and optimization
- Process development (fed-batch, perfusion, co-culture)
- Clinical and commercial-scale GMP manufacturing
- Advanced downstream purification and formulation
- Regulatory support and QC analytics
From bench to metric-ton, we streamline the path from discovery to deployment.
2. Unmatched Microbial Platform Versatility
Whether you’re engineering a rare therapeutic enzyme or scaling a synthetic amino acid, Elise’s platform breadth is unmatched. We specialize in:
Yeast Systems
- Pichia pastoris: for high-titer recombinant biologics
- Saccharomyces cerevisiae: for food proteins and aroma compounds
- Hansenula & Kluyveromyces: for dairy proteins and thermostable enzymes
Bacterial Hosts
- E. coli: plasmid DNA, enzymes, specialty carbohydrates
- Bacillus subtilis: spore-based products, CRISPR tools
- Streptomyces/Corynebacterium: for vitamins, novel small molecules
Anaerobes & Fungi
- Clostridium, Rhodococcus: solvent pathways, bioplastics
- Aspergillus, Trichoderma: carbohydrases, metabolites
We even support AI-designed strains and co-culture systems, enabling innovation in synthetic biology and alt-protein markets.
3. Industrial-Scale Fermentation Infrastructure
Unlike many microbial CDMOs that hit scale-up barriers, Elise offers a seamless fermentation continuum:
| Stage | Volume | Output |
|---|---|---|
| Discovery Pods | 2–10 L | >120 DOE runs/month |
| Pilot Suites | 20–100 L | 1–5 kg/batch |
| Clinical GMP | 300–3,000 L | 5–50 kg/batch |
| Commercial Trains | 5,000–14,500 L | 100 kg–metric ton |
All vessels are ISO-classified, with CIP/SIP sterilization, real-time analytics, and Part 11–compliant electronic batch records. Whether you need a Phase I lot or a long-term supply strategy, Elise is built to scale with you.
4. Smart Automation & Data-Driven Optimization
Modern microbial CDMOs must do more than grow cells—they must learn and adapt from every run. Elise’s SCADA 3.0 platform and digital twins do exactly that:
- Cascading PID loops maintain pH, DO, agitation, feed rate
- Off-gas mass spectrometry and Raman spectroscopy monitor metabolism
- In-silico models identify trends, predict failure modes, and recommend set-point adjustments
- Our 24/7 command center solves issues in hours, not days
This ensures repeatability, yield stability, and rapid troubleshooting—crucial for regulated markets and investor timelines.
5. Comprehensive Downstream & Final Product Finishing
Purification is where many fermentation projects fail—but Elise’s flexible DSP (downstream processing) stack prevents bottlenecks:
- Cell Disruption: high-pressure homogenization, bead mills
- Clarification: disc-stack & tubular centrifugation
- Purification: multi-modal chromatography (affinity, IEX, HIC, SEC)
- Formulation: lyophilized cake, spray-dried powder, beadlets, or bulk liquid
- Fill/Finish: ISO 5 isolators for preclinical or diagnostic products
We support everything from bulk intermediates to final GMP drug substance, reducing the need for risky tech transfers.
6. Analytical Depth & GMP-Ready QC
Elise Biopharma integrates state-of-the-art QC systems, aligned with FDA and EMA expectations:
- UHPLC, MALDI, CE-SDS, LC-MS/MS
- Host cell protein, residual DNA, endotoxins
- Stability studies per ICH Q1A
- Method validation and seamless transfer to fill-finish or external partners
With audit-ready systems, Elise accelerates your regulatory journey.
7. Flexible Engagement Models
Elise offers multiple CDMO service models to meet your needs and budget:
- Concept-to-IND Package: from strain engineering to clinical CMC support
- Tech-Transfer Sprint: scale your existing process in 30 days
- Capacity Lease: reserve GMP trains for 6–36 months
- Pay-as-you-go Pilot Runs: monthly slots perfect for startups
This flexibility reduces risk, aligns with funding cycles, and protects your intellectual property.
8. Regulatory Excellence & Global Compliance
Elise is ISO 13485, ISO 9001 certified, and FDA registered for IVD enzymes. We’ve helped customers file across:
- FDA (USA)
- EMA (Europe)
- CFDA (China)
Our RA/QA experts have filed successful dossiers for enzymes, live biotherapeutics, plasmid DNA, and more. Plus, 21 CFR Part 11–aligned systems guarantee data integrity and inspection-readiness.
9. Sustainable Biomanufacturing
Today’s leaders want more than just output—they demand sustainability:
- 100% renewable power at our flagship by Q3 2025
- Water and solvent recycling systems
- Biomass valorization into feed or biochar
- Dual-sourced raw materials and multi-region seed banks for resilience
Elise is committed to a greener, more reliable future in microbial biomanufacturing.
Real-World Applications Elise Supports
Here are just a few high-value use cases our microbial CDMO platform enables:
- Next-gen biologics: Recombinant enzymes, vaccine antigens, cytokines
- Alternative proteins: Fermented whey, casein analogues, bioactives
- Diagnostics: Enzymes for point-of-care tests or ELISA kits
- Industrial biotech: Bioplastics, biofuels, specialty solvents
- AgTech: Plasmids and live cultures for engineered crops
- Beauty & wellness: Post-biotic skincare actives
Whether you’re pioneering a new biotech modality or scaling a trusted standard, Elise is built to deliver.
Partner with the Best in Microbial CDMO Services
In the competitive landscape of microbial fermentation, Elise Biopharma delivers the rare combination of technical rigor, regulatory strength, and operational flexibility. Whether you’re scaling your first batch or launching a global commercial product, Elise offers the tools, team, and technology to bring your vision to life.
Contact us today to discuss how Elise can support your next-generation product—because the future of biotech deserves a better microbial CDMO.