The mammalian transient expression services, leveraging its highly biomimetic post-translational modification capabilities, serves as a cornerstone platform for producing biologics such as antibody drugs and fusion proteins. Compared to prokaryotic and eukaryotic microbial systems, its expressed products exhibit closer alignment with native human proteins in glycosylation precision, protein folding accuracy, and functional activity consistency, making it ideal for industrial-scale production of therapeutic proteins.
Breakthrough in Technical Barriers: Ipodix Engineering Solutions
Industry Challenges | Ipodix Innovations |
Glycosylation heterogeneity affecting drug efficacy | Custom glycosylation modulation (GnT-I/KO cell lines + feed medium dynamic regulation) to achieve >90% homogeneous G0F/G2F glycosylation |
Low transient expression yield | High-density suspension culture technology (viable cell density up to 2×10⁷ cells/mL), increasing protein expression by 3-5× |
Unstable plasmid transfection efficiency | Proprietary cationic liposome transfection reagent with >85% transfection efficiency |
Batch-to-batch inconsistency | Integrated Process Analytical Technology (PAT) with key parameter CV <5% (online monitoring of pH/DO/metabolites) |
End-to-End Service Platform
1. Cell Line Development
● Host selection: HEK293 (rapid expression) / CHO-K1 (stable production) / customized engineered lines (e.g., FUT8-KO)
● Vector design: CMV/T7 dual promoter system with HRV 3C protease cleavage site and Kozak sequence optimization
2. Process Development
● Medium optimization: Animal-origin-free (AOF) medium with dynamic feeding strategy (glucose/glutamine smart regulation)
● Scalable culture: Linear scale-up from 15 mL shake flasks to 2000 L bioreactors (yield deviation <10%)
3. Quality Control
● Glycosylation profiling: MALDI-TOF mass spectrometry + GlycoWorks RapiFluor-MS rapid detection
● Bioactivity validation: SPR binding affinity (KD determination) + reporter gene assays (IC50/EC50 functional verification)
Core Service Modules
✦ Base Service Package
├─ Gene synthesis & codon optimization (Homo sapiens preference)
├─ Expression vector construction (pcDNA3.4/pTT5 multi-system options)
├─ Small-scale __expression (0.1-2L systems, delivery within 4-6 weeks)
└─ Protein purification (Protein A/G affinity chromatography, >95% purity)
✦ Premium Add-Ons
├─ Glycoengineering (sialic acid modulation/fucose knockout)
├─ Endotoxin removal (<0.01 EU/μg, USP <85 compliant)
├─ Formulation development (liquid/lyophilized stability testing)
└─ Analytical method development (SEC-MALS molecular weight validation)
Techno-Economic Advantages
● Accelerated timelines: Transient expression projects deliver milligram-level samples in 21 days (QC-inclusive).
● Cost efficiency: Proprietary serum-free media reduce costs by 60% vs. imported brands.
● High success rate: >75% soluble expression success for complex proteins (e.g., transmembrane domains).
● Regulatory readiness: Full support for DMF templates and ICH Q5D-compliant data packages.
Key Applications
▷ Bispecific antibodies: CD3×CD19 bispecific antibody yield reaches 800 mg/L (HEK293 system).
▷ Virus-like particles (VLPs): HPV L1-VLP production exceeds 5 mg/10⁹ cells.
▷ Cell therapy support: GMP-grade scFv fragments for CAR-T (inter-batch HCP <100 ppm).
Why Ipodix?
☑ 1000+ mammalian protein expression projects completed.
☑ Proprietary cell line bank (50+ engineered HEK/CHO derivatives).
☑ ISO9001-certified quality system.
☑ Real-time process monitoring (client-accessible cultivation parameters).
