Precision Fermentation at Elise Biopharma
Harnessing microbes—from benchtop discovery to global supply.
At Elise Biopharma, microbial fermentation sits at the heart of everything we do. Building on EKF Diagnostics’ three decades of know‑how, we have re‑engineered those proven assets into a next‑generation, fully integrated platform purpose‑built for speed, flexibility, and GMP reliability. Whether you are a venture‑backed start‑up chasing an orphan‑protein breakthrough or a blue‑chip manufacturer replacing petrochemicals with bio‑based inputs, we provide the infrastructure, talent, and regulatory depth to move your program from concept to commercial reality—without the usual scale‑up headaches.
1 Microbial Platforms We Master
Yeasts
- Pichia pastoris – high‑titer secretion of enzymes, vaccine antigens, and glyco‑engineered biologics
- Saccharomyces cerevisiae – food proteins, aroma compounds, advanced biofuels
- Hansenula polymorpha & Kluyveromyces spp. – thermostable enzymes, dairy proteins, low‑cost feed supplements
Bacteria
- E. coli – recombinant proteins, plasmid DNA, synthetic amino‑acids, specialty polysaccharides
- Bacillus subtilis – GRAS enzyme chassis, spore‑based probiotics, CRISPR components
- Corynebacterium & Streptomyces – vitamins, antibiotics, novel small‑molecule precursors
- Lactobacillus & other facultative anaerobes – post‑biotic ingredients, live bio‑therapeutics
Filamentous Fungi & Specialty Strains
- Aspergillus & Trichoderma – industrial carbohydrases, secondary metabolites
- Obligate anaerobes (Clostridium, Rhodococcus) – solventogenic pathways, bioplastic monomers
- Custom AI‑designed chassis & co‑culture systems—tailored to your IP and performance targets
2 Fermentation Infrastructure & Scale‑up Continuum
| Train | Working Volume | Configuration | Typical Output |
|---|---|---|---|
| Discovery Pods | 2 – 10 L single‑use | 12 parallel vessels, automated feeding & off‑gas MS | >120 DOE runs/month |
| Pilot Suites | 20 – 100 L mobile stainless/glass | BSL‑2 capability, ATF or TFF perfusion, in‑line sterile harvest | 1–5 kg protein / batch |
| Clinical GMP | 300 L, 1 000 L, 3 000 L fixed stainless | Class 10 000 cleanrooms, CIP/SIP, segregated upstream & downstream flows | Ph I–III batches, 5–50 kg |
| Commercial Trains | 5 000 L – 14 500 L | Multiple trains for aerobic & anaerobic processes, redundant utilities | 100 kg – metric‑ton lots |
All suites feature ISO‑classified, HEPA‑filtered air, validated cleaning cycles, and dedicated media/buffer prep to eliminate cross‑contamination. Electronic batch records and historian data underpin traceability from seed vial to released lot.
3 Smart Automation & Real‑Time Insight
- PLC/SCADA 3.0 with cascading PID control for pH, DO, agitation, back‑pressure, antifoam, and feed strategy
- Advanced sensors: capacitance biomass probes, off‑gas mass‑spec, Raman spectroscopy for metabolite fingerprinting
- Digital Twins: in‑silico models that learn from each run, predict failure modes, and recommend set‑point optimizations
- 24 / 7 Command Center staffed by fermentation engineers and data scientists—issues solved in hours, not days
4 Downstream Processing & Finishing
- High‑pressure homogenization (20 kpsi) or bead‑mill disruption
- Disc‑stack & tubular centrifugation, depth & microfiltration
- TFF / UF‑DF with cassettes up to 10 m² for rapid concentration & buffer exchange
- Multi‑modal chromatography (IEX, affinity, mixed‑mode, HIC, SEC) on single‑use or stainless skids
- Formulation options: bulk liquid, lyophilized cake, spray‑dried powder, or stabilized beadlets
- Final fill/finish under ISO 5 isolators for diagnostic enzymes or phase‑I biologics
5 Integrated Analytical & QC Services
- On‑line PAT plus rapid UHPLC, LC‑MS/MS, MALDI, SDS‑PAGE, CE‑SDS, ELISA, qPCR
- Host‑cell protein/DNA, endotoxin, and residual solvent panels
- Stability studies (ICH Q1A), accelerated & real‑time
- Method development, validation, and transfer to external fill‑finish sites—or stay in our network for an end‑to‑end GMP release
6 Engagement Models Built for You
- Concept‑to‑IND Package
- Strain engineering, fed‑batch/perfusion development, tox material, CMC dossier drafting
- Scale‑up & Tech‑Transfer Sprint
- Your existing process, our vessels—30‑day sprint to generate engineering batch and gap analysis
- Dedicated Capacity Lease
- Reserve an entire train for 6–36 months; protect supply, align with launch forecasts
- Flexible Pilot Slots
- Monthly pay‑as‑you‑go runs for synthetic biology start‑ups—perfect for investor milestones
7 Quality, Regulatory & Compliance
- ISO 13485 & ISO 9001 certified; FDA‑registered for in‑vitro diagnostic enzymes
- Full GMP documentation suite: MBRs/EBRs, deviation & CAPA systems, change control, annual product review
- Experienced RA/QA team with successful dossiers across FDA, EMA, and CFDA for proteins, enzymes, plasmids, and live‑biotherapeutic products
- Data integrity aligned with 21 CFR Part 11—secure, audit‑ready, cloud‑redundant archives
8 Sustainability & Supply‑Chain Resilience
- 100 % renewable electricity at our flagship site by Q3 2025
- Closed‑loop water recapture, solvent‑recycling, and biomass valorization into animal feed or bio‑char
- Multi‑regional seed banks and dual‑sourced raw materials to de‑risk geopolitical shocks
9 Why Choose Elise Biopharma?
| Your Need | Our Advantage |
|---|---|
| Rapid proof‑of‑concept for a novel scaffold | Discovery Pods complete 120 DOE fermentations per month—rank strains in weeks |
| Seamless scale‑up without loss of yield | Digital twins + geometric similarity scaling ensure linear productivity from 2 L to 14 500 L |
| Audit‑ready clinical supply | ISO‑classified suites, Part 11 EBRs, and veteran QA keep inspections painless |
| Cost‑effective commercial lots | High‑density fed‑batch, energy‑efficient utilities, and continuous DSP drive COGS down |
| Long‑term strategic partner | Capacity‑lease model plus tech‑transfer toolkits protect your IP and timeline |
10 Next Steps: Turn Microbial Potential into Market Reality
Whether you aim to:
- Express a next‑gen therapeutic enzyme at kilogram scale
- Replace animal‑derived growth factors with precision‑fermented analogues
- Manufacture plasmid DNA for gene‑edited crops
- Launch a post‑biotic cosmetic active or fermented food protein
Elise Biopharma brings the microbial horsepower, regulatory rigor, and commercial mindset to make it happen—first time, every time.
Talk to a Fermentation Specialist
Email [email protected] Let’s transform your vision into scalable, sustainable, and profitable reality.