AI Antibody Engineering · Proprietary Cell Line

PCSK9 Antibody Pair

AI-Matured Sub-Nanomolar Anti-PCSK9 Antibody with High-Titer Proprietary Cell Line Production

AI EngineeringPCSK9Sub-nM AffinityCHO PlatformOEM
<0.5 nM
Binding Affinity (KD)
4.5 g/L
Fed-Batch Titer
>98%
Monomer Purity
~50%
Faster Development

Next-Generation PCSK9 Inhibition Through AI + Cell Line Engineering

The PCSK9 Antibody Pair represents the output of Sekbio's integrated AI antibody engineering and proprietary CHO cell line platform. PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) promotes lysosomal degradation of hepatic LDL receptors, raising plasma LDL-C. Inhibition of PCSK9 preserves LDLR and reduces cardiovascular risk.

Using AlphaFold2 structural modeling, protein language model (PLM) guided CDR diversification, and ΔΔG-ranked in silico screening, Sekbio engineered a variant antibody with KD <0.5 nM — a >30-fold improvement over the parental antibody. Combined with a proprietary CHO cell line achieving 4.5 g/L fed-batch titer, this antibody is positioned for both therapeutic development and diagnostic assay OEM supply.

AI-Driven EngineeringProprietary CHO PlatformISO 13485 ManufacturerTherapeutic & Diagnostic

Analytical Specifications

Target AntigenPCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)
Antibody FormatAnti-PCSK9 Monoclonal IgG
Binding Affinity (KD)< 0.5 nM (AI-optimized)
Fed-Batch Titer4.5 g/L (lab scale)
SEC-HPLC Purity≥ 99%
CE-SDS Purity91.9%
Monomer Purity> 98%
Development Cycle6–7 months (~50% reduction)

AI × Cell Line: Dual Engineering Advantage

Two complementary engineering platforms that simultaneously maximize affinity and manufacturability.

AI-Driven Affinity Maturation

Protein language models (PLM) and ΔΔG binding free energy prediction screen 10⁵–10⁶ in silico variants, identifying top CDR mutations for >30-fold affinity improvement over the parental antibody.

Sub-Nanomolar Binding Affinity

AI-engineered variant achieves KD <0.5 nM — a >30-fold improvement from the parental ~15 nM. Slower koff provides extended target occupancy critical for PCSK9 blockade efficacy.

Proprietary CHO Cell Line Platform

Sekbio's engineered CHO-derived host optimizes secretion, folding, and stable integration sites. Compatible with fed-batch and perfusion processes for GMP-ready scale-up.

Industry-Leading Expression Titer

Achieves 4.5 g/L in standard fed-batch at lab scale — a >5-fold improvement over the parental 0.8 g/L. Stable for ≥30 generations without titer decline.

Superior Biophysical Quality

>98% monomer purity by SEC-HPLC, consistent glycan profile, and low aggregation propensity. Favorable biophysical properties support downstream formulation and long-term stability.

Accelerated Development Timeline

Combined AI affinity maturation and proprietary cell line development reduces time from candidate to stable cell line from 12–14 months to 6–7 months — ~50% cycle time reduction.

Analytical & Clinical Data

Performance data from Sekbio AI antibody engineering workflow and proprietary CHO cell line platform.

1 AI Affinity Maturation — Comparative Results

AlphaFold2 Multimer and IgFold structural modeling were used to define critical epitopes on the PCSK9 catalytic domain and EGF-AB binding interface. Protein language model-guided CDR diversification followed by ΔΔG-ranked in silico screening identified the optimized variant.

ParameterParental AntibodyAI-Engineered VariantImprovement
Binding Affinity (KD)~15 nM~0.45 nM>30-fold
Fed-Batch Titer~0.8 g/L4.5 g/L>5-fold
Monomer Purity~95%>98%Improved
Development Cycle12–14 months6–7 months~50% reduction
AI workflow: AlphaFold2 Multimer structure modeling → PLM-guided CDR diversification → ΔΔG-ranked screening → wet-lab validation.
2 Recombinant PCSK9 Protein Production

Sekbio's proprietary CHO cell line platform was applied to produce recombinant PCSK9 antigen for antibody validation and assay development. The production run demonstrates high volumetric yield and analytical-grade purity.

ParameterResult
Expression Volume1,000 mL
Protein Concentration4.48 mg/mL
Total Yield1,314 mg
Purity — SEC-HPLC99%
Purity — CE-SDS91.9%
Production at lab scale (1 L fed-batch). Concentration and purity assessed post-purification.
3 Cell Line Stability

The proprietary CHO-derived stable cell line maintains consistent expression titer over extended passaging, confirming suitability for commercial-scale manufacturing.

Stability result: Titer maintained at ≥4.5 g/L for ≥30 generations without detectable decline. Consistent glycan profile and aggregation levels across passages confirm genomic integration stability and manufacturing readiness.

Applications

Anti-PCSK9 antibody and PCSK9 recombinant protein validated for therapeutic, diagnostic, and research applications.

Cardiovascular Therapeutic Development

Anti-PCSK9 antibody as therapeutic candidate for hypercholesterolemia and cardiovascular disease. AI-matured affinity and cell line platform support accelerated IND-enabling studies.

Diagnostic Immunoassay Development

Anti-PCSK9 antibody pair for sandwich immunoassay development targeting quantitative serum PCSK9 measurement in clinical cardiovascular risk stratification.

Recombinant Protein Supply

PCSK9 recombinant antigen (99% SEC-HPLC purity, 4.48 mg/mL) available for antibody screening, assay calibration, and research applications.

AI Antibody Engineering Services

End-to-end AI-driven antibody optimization service: structure modeling, PLM-guided affinity maturation, and proprietary cell line development. Available for custom targets.

Ready to Partner on PCSK9 Development?

Request the full technical datasheet, antibody specifications, or discuss OEM supply, licensing, and AI engineering services with our team.

Guangming District, Shenzhen, China