HCD/HCP Custom Kit Development Service
Custom assay development for Residual Host Cell DNA (HCD) and Host Cell Protein (HCP)—from antigen/assay design to kit validation and routine supply.
What We Offer
Two end-to-end customization tracks to match your process and regulatory needs.
HCP ELISA Kit Customization
- Host-specific / process-specific HCP
- Polyclonal/monoclonal strategy (if applicable)
- Coverage evaluation support
HCD Residual DNA Kit Customization
- qPCR-based residual DNA quantification
- Low-background design & NTC control strategy
- Matrix compatibility & inhibition assessment
Designed for Bioproduction Workflows
Applicable to upstream and downstream samples across common expression systems.
Cell line: CHO / HEK293 / E. coli / Yeast
Sample types: clarified harvest / Protein A eluate / intermediate / DS
Goals: release testing, process monitoring, comparability, tech transfer
HCP Custom Kit Development Workflow
A structured development pathway—from antigen preparation to coverage assessment.
Antigen Preparation
Animal Immunization
Antibody Generation
Kit Development
Kit Verification / Validation
Kit Manufacturing
Coverage Detection
HCD Residual Host Cell DNA Kit Development Workflow
A structured qPCR assay development process—from target design and standard preparation to validation, release testing, and kit supply.
Requirement Analysis
Literature & Regulatory Research
Sequence Conservancy & Specificity Analysis
Primer/Probe Design & Synthesis
Reference Standard Preparation
Assay Optimization & Performance Verification
Stability Study & Delivery
Validation & Quality Assurance Framework
Assay validation aligned with ICH Q2 principles and GMP-aligned production control.
Method Validation Scope
- Sensitivity (LOD)
- Precision (Intra / Inter-assay)
- Specificity & Interference
- Linearity & Range
- Recovery & Matrix Effect
Quality & Supply Assurance
- QA/QC Review & Release
- Batch Traceability
- Documentation Package (COA, MSDS, IFU)
- Long-Term Supply Planning