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Client
Biotech company
Sector
Pharmaceuticals
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Research Domain
Immunology
Pipeline stage
Scale-up/Pre-clinical
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Key Processes
- Antibody sequence synthesis & vector design
- Transient expression with XtenCHO® Race & purification
- Yield, consistency and performance evaluation
Key Numbers
<10
EU/mL
Low Endotoxin levels
>90%
Purity
10.63
mg/200mL
Yield after scale-up
Context
A pharmaceutical company developing a recombinant antibody for rheumatoid arthritis and advancing toward preclinical validation wanted to confirm the robustness of the yield of their lead candidate during a 200 mL scale-up. The objective was to observe its performance under strict quality requirements, ensuring the candidate remained promising for the next stages of development.
Challenges
1
Delivering sufficient yields (5–10 mg per construct) to support downstream studies
2
Maintaining high purity (>90%) across all constructs
3
Achieving low endotoxin levels suitable for preclinical applications
4
Need to scale production from 30 ml to 200 ml while ensuring reproducibility
ProteoGenix Approach
Sequence synthesis & subcloning into expression vector
XtenCHO® Race transient transfection (200 ml scale)
14-day culture & harvest
Nickel affinity purification (His-tag)
QC: SDS-PAGE, UV quantification, endotoxin assay
Results
At the 200 ml scale, ProteoGenix produced two scFv variants with yields of 5.78 mg (WT) and 10.63 mg (H13). Both reached >90% purity and maintained low endotoxin levels (<10 EU/ml), meeting preclinical research requirements. This ensured a smooth transition from pilot to mid-scale production, delivering reproducible quantities suitable for functional and validation studies.
Key Takeway
The scale-up confirmed that the candidate remains promising for further development. The client obtained the large quantity they required under strict purity conditions, allowing them to confidently continue their program.
