Protein Expression &
Antibody Development Platform

From antigen design to fully characterized antibody — Sekbio's mammalian expression systems and end-to-end antibody development services accelerate your IVD and biopharmaceutical programs.

7-Day CHO Delivery Up to 2.4 g/L Yield AI-Optimized Design 1,800+ Expressions Completed ISO 9001:2015 QC
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800+
Successful Expression Projects
1,800+
Proteins Expressed (HEK293)
7
Days — CHO Express Delivery
2.4 g/L
Peak CHO Expression Yield

What Is an IVD Antibody Development Service?

An IVD antibody development service is a contract research and manufacturing offering that takes a diagnostic target — a disease biomarker such as CEA, PSA, Troponin I, or HCV antigen — and produces fully characterized monoclonal antibodies validated for use in clinical diagnostic assays. Unlike research-grade antibody suppliers, a specialized antibody developer and manufacturer for IVD must meet additional requirements: antibody pairs must perform as capture and detection reagents in sandwich immunoassay formats, lot-to-lot consistency must be rigorously controlled, and the entire production process must operate under a certified quality management system such as ISO 13485.

Sekbio's IVD antibody development workflow integrates three core capabilities into a single service platform:

  • Antibody Discovery & Hybridoma Development — immunization, hybridoma generation, high-throughput screening, and lead clone selection tailored to IVD assay performance criteria
  • Recombinant Protein Expression — CHO and HEK293 mammalian expression for antibodies, antigens, and fusion proteins requiring native glycosylation and human-like post-translational modifications
  • Diagnostic-Grade Purification & QC — Protein A/G affinity chromatography, SEC-HPLC purity verification (>90%), endotoxin testing (<1.0 EU/mg), and batch release documentation for IVD manufacturers

For IVD companies developing antibody raw materials for lateral flow assay (LFA), CLIA, or ELISA platforms, partnering with an experienced antibody developer and manufacturer reduces development risk, compresses timelines, and ensures the final reagent meets the performance specifications required for clinical diagnostic use.

CHO Expression Platform

Sekbio's proprietary CHO system represents the pinnacle of mammalian cell expression technology — delivering unprecedented speed and yield for protein production, from milligram screening to >100 L manufacturing.

CHO High Throughput
Screening of 1,000+ constructs for optimal expression conditions
CHO Express
10 mg protein delivery in minimal turnaround — ideal for urgent timelines
CHO High Performance
Large-scale production for preclinical studies and IVD raw material supply
CHO Stable Cell Lines
Antibody stable cell line CHO development for consistent, long-term IVD production

Core Advantages

  • 7-Day Expression: Rapid protein delivery for urgent research needs
  • High-Yield Performance: Achieves up to 2.4 g/L protein expression
  • AI-Optimized Design: Machine learning-driven construct optimization
  • Scalable Production: From 1 mL screening to >100 L manufacturing
  • Comprehensive QC: >90% purity with full analytical characterization
Purity: >90% by SEC-HPLC Endotoxin: <1.0 EU/mg Aggregation: <5% by SEC Scale: 1 mL → 100+ L
Request CHO Expression →

Supported Protein Types

  • Monoclonal antibodies (IgG, IgM, IgA)
  • Mouse anti human antibody development for immunoassay capture/detection conjugates
  • Bispecific and multispecific antibodies
  • Antibody fragments — Fab, scFv, VHH (nanobody)
  • Fusion proteins and Fc fusion constructs
  • Cytokines and growth factors
  • Enzymes and therapeutic proteins
  • Recombinant antigens for IVD raw materials

HEK293 Expression Systems

Complementing our CHO platform, Sekbio offers comprehensive HEK293 transient and stable recombinant protein expression services for IVD — with 1,800+ successful expressions completed to date.

Available Cell Lines

  • HD293F — high-density suspension culture
  • Expi293F — enhanced transient expression
  • Expi293 GnTI⁻ — afucosylated glycan engineering
Scale: 40 mL – 200 L bioreactor Glycoengineering: Controlled glycosylation Track Record: 1,800+ proteins

Why Choose HEK293?

HEK293 systems produce proteins with human-like post-translational modifications and glycosylation patterns — critical for proteins where glycan structure affects function, immunogenicity, or half-life.

Key Applications

  • Antibodies requiring native glycosylation
  • Recombinant antigens for diagnostic assay development
  • Glycoengineered antibodies (afucosylated for ADCC)
  • Virus-like particles (VLPs) and complex assemblies
  • Rapid feasibility and expression screening
Inquire About HEK293 →

Monoclonal Antibody Development

End-to-end mouse monoclonal antibody services — from antigen design and custom immunization to fully characterized antibody production. Lead candidates delivered in 8–12 weeks.

1
Antigen Preparation & Immunization
  • Recombinant protein expression and purification
  • Peptide synthesis and carrier conjugation
  • Custom immunization protocols (4–8 weeks)
  • Serum titer monitoring and optimization
2
Hybridoma Generation & Screening
  • Spleen cell fusion and hybridoma selection
  • High-throughput ELISA screening
  • Single-cell cloning by limiting dilution
  • Expansion and cryopreservation of positive clones
3
Antibody Characterization
  • Binding Analysis: ELISA, Western blot, flow cytometry
  • Affinity Measurement: SPR/BLI kinetics (KD determination)
  • Specificity: Cross-reactivity and epitope mapping
  • Functional Testing: Neutralization, blocking, effector function
4
Production & Purification
  • Small-scale (mg) to large-scale (g) production
  • Protein A/G affinity chromatography
  • Dedicated IgM purification service via SEC and ion-exchange chromatography, since Protein A/G does not efficiently bind IgM isotypes
  • Buffer exchange and formulation optimization
  • Full QC documentation — antibody purification service to diagnostic grade
>90%
Hybridoma Success Rate
20–50
Specific Clones per Fusion
nM–pM
Achievable Affinity Range
8–12 wk
To Lead Candidates
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Specialized Capabilities

Beyond standard expression and hybridoma services, Sekbio offers advanced antibody discovery services for IVD clients globally — from AI-assisted design and high-throughput screening to full engineering solutions for the most challenging antibody development problems.

AI-Assisted Antibody Design

  • Computational antibody-antigen interaction prediction
  • Optimized library design with AI-guided diversity
  • In silico affinity maturation
  • Developability assessment for manufacturability

High-Throughput Screening

  • Beacon® optofluidic system for single-cell analysis
  • Next-generation sequencing of antibody repertoires
  • Microfluidic screening for rare clones
  • Automated colony picking and expansion

Antibody Engineering

  • Humanized Antibody Development: CDR grafting & framework optimization to convert mouse antibodies into humanized monoclonal antibodies
  • Affinity Maturation: Library construction & screening
  • Format Conversion: IgG → Fab, scFv, or VHH
  • Bispecific Engineering: T-cell engagers & dual-targeting

Technical Specifications & Quality Metrics

Mammalian Expression Quality

ParameterSpecification
Purity>90% by SEC-HPLC and SDS-PAGE
IgM PurificationSEC/ion-exchange igm purification kit workflow (Protein A/G-independent)
Endotoxin<1.0 EU/mg
Aggregation<5% by SEC-HPLC
SterilityUSP <71> compliant
ConcentrationVerified by A280 and BCA
Peak Yield (CHO)Up to 2.4 g/L
Scale Range1 mL – >100 L
Quality StandardISO 9001:2015 certified

Antibody Development Success Rates

MilestonePerformance
Hybridoma Generation>90% success rate
Positive Clone IdentificationTypically 20–50 clones / fusion
Achievable AffinitynM to pM range (SPR/BLI confirmed)
Project Completion8–12 weeks to lead candidates
GMP ComplianceGMP-compliant facilities available
DocumentationFull regulatory submission package
Projects Completed800+ expression projects
Global Clients200+ clients worldwide

Frequently Asked Questions

Common questions about Sekbio's antibody development and manufacturing services.

An IVD antibody development service provides end-to-end support for generating, expressing, and qualifying monoclonal antibodies for in vitro diagnostic (IVD) assays — covering antigen design, immunization, hybridoma generation, recombinant expression (CHO or HEK293), antibody characterization, and purification to diagnostic grade. Unlike research-grade antibody suppliers, a specialized antibody developer and manufacturer for IVD must ensure antibody pairs perform in sandwich immunoassay formats (LFA, CLIA, ELISA), maintain lot-to-lot consistency, and operate under ISO 13485 quality management. Sekbio delivers validated antibody pairs ready for IVD kit development, serving 200+ IVD brands across 30+ countries.
Sekbio's CHO Express service delivers 10 mg of expressed protein in as little as 7 days, making it one of the fastest mammalian expression services available for urgent IVD research and development needs.
Sekbio's end-to-end hybridoma antibody development service takes 8–12 weeks for lead candidates, covering antigen preparation, immunization, hybridoma generation, antibody characterization, and purification. Expedited timelines are available for select targets.
All intellectual property — hybridoma cell lines, antibody sequences, affinity data, and characterization reports — belongs solely to the client upon project completion. Sekbio operates as a contract antibody developer and manufacturer; all work is conducted under NDA and client data is never shared with or reused for third parties.
Yes. Sekbio's antibody purification service for diagnostic-grade reagents includes Protein A/G affinity chromatography, SEC-HPLC purity verification (>90%), endotoxin testing (<1.0 EU/mg), and aggregation analysis (<5% by SEC). A Certificate of Analysis and full lot release documentation are provided with every shipment.
Yes. Sekbio's antibody discovery service for IVD diagnostics serves clients globally — including Europe (Germany, Italy, Turkey), North America, South Korea, Japan, and India. Services cover de novo antibody discovery, hybridoma development, recombinant antibody engineering, and stable cell line establishment for commercial IVD raw material supply.

Ready to Accelerate Your Protein & Antibody Programs?

Our PhD-level scientists are ready to discuss your project requirements. Get a technical consultation and custom quote within 24 hours.

Request a Quote Email info@sekbio.com