Mammalian Cell Culture & Cell‑Line Excellence
Elise Biopharma—turning complex biology into clinical reality.
Building on our precision‑fermentation heritage, Elise Biopharma delivers the same obsession with data, rigor, and speed to mammalian cell culture. From first‑in‑gene concepts to commercial cGMP supply, we engineer, optimize, and scale high‑yield CHO, HEK, NS0, and other mammalian systems—so your antibodies, fusion proteins, viral vectors, or next‑gen modalities reach the clinic (and the market) faster and stronger.
1 End‑to‑End Mammalian Platform
| Milestone | What We Deliver |
|---|---|
| Gene‑to‑Pool (Week 0‑6) | Codon‑optimized gene synthesis, vector construction, transfection, and high‑throughput screening in 96‑well format |
| Pool‑to‑Clone (Week 6‑14) | Mini‑bioreactor (Ambr 15/250) DOE for media & feed, Top‑6 clone down‑selection, stability studies ≥60 gens |
| Clone‑to‑Clinic (Week 14‑24) | Fed‑batch or perfusion process fit to 50 L, then to 200 L single‑use, generating tox / Ph I GMP drug substance |
| Clinic‑to‑Commercial | 500 L & 2 000 L stainless trains, validated scale‑down models, PPQ, CPV, and global regulatory dossiers |
2 Cell‑Line Development Mastery
- CHO: K1, CHO‑ZN®, CHO‑DG44—GS or DHFR selection, knock‑ins for enhanced glycosylation or ADCC
- HEK293: Suspension‑adapted, ideal for viral vectors, membrane proteins, and difficult‑to‑fold payloads
- NS0 & BHK21: High‑titer IgG and vaccine antigens
- Customer‐Specified Lines: Bring your own lineage; we plug into our high‑throughput workflow
Productivity Benchmarks
- mAbs → Average 6 g/L, best‑in‑class up to 12 g/L
- Bispecifics → Average 6.5 g/L, up to 10 g/L across multiple formats
- Complex proteins → Up to 14 g/L with optimized media/feed
If a stable clone falls below 3 g/L for standard IgG, we rerun the program at no additional cost—our confidence in performance is that high.
3 Process‑Development Arsenal
- Six‑Sigma & QbD: Formal DOE, FMEA, CPP/CQA mapping, and risk‑based control strategies
- Miniaturized Bioreactors: Parallel Ambr 15 & 250 mL fed‑batch/perfusion mimic 1 000 L profiles—50 % faster optimization cycles
- Smart PAT Integration: Raman/FTIR for real‑time metabolite fingerprints; capacitance for viable biomass; in‑line glucose/lactate analyzers
- Harvest & Clarification: Depth‑filter trains, continuous kSep®/tubular centrifugation, microfiltration tailored to shear‑sensitive products
- Cryopreservation & Cell‑Banking: Controlled‑rate freezing, GMP Master/Working Cell Banks, ICH stability testing
4 Scale, Suites & Compliance
| Suite | Bioreactor Options | Class | Typical Use |
|---|---|---|---|
| PD Labs | 2 – 3 L glass & Ambr 250 | ISO 7 | Media, feed, clone screens |
| Pilot GMP | 50 L / 200 L single‑use | ISO 7 / 5 core | Tox & Ph I lots |
| Clinical GMP | 500 L single‑use / 1 000 L stainless | ISO 7 / 5 core | Ph II/III |
| Commercial | 2 000 L perfusion / 15 000 L fed‑batch | ISO 8 / 7 core | Launch & supply |
All suites feature electronic batch records (21 CFR Part 11), segregated air handling, validated CIP/SIP, and on‑line utility monitoring. Our QA/RA veterans have filed >200 INDs and three BLA/MAA dossiers—audit‑ready wherever you market.
5 Analytics & CMC Integration
- Bioassays: CE‑SDS, icIEF, SEC‑HPLC, SPR binding, Fc effector function
- Impurity Panels: Host‑cell protein/DNA, endotoxin, residual Protein A
- Stability & Forced Degradation: ICH Q1A, accelerated, thermal, photolytic
- Regulatory Writing: Cell‑line history, adventitious agent testing, viral clearance, PPQ protocols
Combine upstream, downstream, and analytical workflows under one roof for a seamless CMC package—and a single point of accountability.
6 Why Elise Biopharma for Mammalian?
Speed Without Shortcuts
10 weeks from DNA to Top‑6 clones, 24 weeks to first GMP lot—accelerated yet fully compliant.
Productivity That Lowers COGS
High‑density fed‑batch, intensified perfusion, and continuous capture reduce media volumes and resin footprints.
Format Agnostic, Science Obsessed
IgGs, bispecifics, Fc fusions, enzymes, cytokines, viral vectors—if a cell can make it, we can scale it.
Transparent Partnership
Real‑time data portals, weekly dashboards, and an open‑door policy keep you in control of every parameter.
US‑Based, Global Reach
American‑made cGMP equipment, consumables, and QC reagents; worldwide logistics for frozen or LNP‑filled DS.
Ready to Engineer Mammalian Success?
Email [email protected] or fill out the form on contact page.