HCD/HCP Custom Kit Development Service
What We Offer
Two end-to-end customization tracks to match your process and regulatory needs.
- Host-specific / process-specific HCP
- Polyclonal/monoclonal strategy (if applicable)
- Coverage evaluation support
- 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.
HCP Custom Kit Development Workflow
A structured development pathway—from antigen preparation to coverage assessment.
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.
Validation & Quality Assurance Framework
Assay validation aligned with ICH Q2 principles and GMP-aligned production control.
- Sensitivity (LOD)
- Precision (Intra / Inter-assay)
- Specificity & Interference
- Linearity & Range
- Recovery & Matrix Effect
- QA/QC Review & Release
- Batch Traceability
- Documentation Package (COA, MSDS, IFU)
- Long-Term Supply Planning
Frequently Asked Questions
Does BIORI develop both HCP and residual host cell DNA kits?
Yes. BIORI offers two project tracks: HCP ELISA kit customization and qPCR-based residual host cell DNA kit customization.
Which expression systems can the custom assays support?
The service page identifies CHO, HEK293, E. coli, and yeast as supported expression-system examples, with the final assay scope defined for the customer's host system, sample matrix, and project requirements.
What validation characteristics can be evaluated?
The listed validation scope includes sensitivity, precision, specificity and interference, linearity and range, recovery and matrix effect, system suitability, and stability.
What is included in the HCD or HCP development workflow?
Depending on the selected track, work can cover antigen preparation and antibody generation for HCP, or target and primer/probe design for HCD, followed by assay or kit development, performance verification, stability work, and manufacturing or delivery.
