HCD & HCP Custom Assay Development
Custom qPCR assays for residual host cell DNA and ELISA kits for host cell proteins, developed around your expression system, sample matrix and testing goals.
Different impurities.
Distinct assay strategies.
Select the development track for the impurity you need to measure. HCD and HCP projects are defined around the relevant host, process and analytical objective.
Residual host cell DNA
Develop a qPCR assay for residual host cell DNA in your expression system and sample matrix.
- Residual DNA quantificationqPCR-based detection of host-derived DNA.
- Background & control strategyLow-background design and no-template controls.
- Matrix compatibilityInhibition assessment within the intended sample matrix.
Host cell protein
Develop an HCP ELISA kit for your host or process, including an appropriate antibody strategy and coverage evaluation support.
- Host / process specificityDevelopment around the relevant host-cell protein population.
- Antibody strategyPolyclonal or monoclonal approaches where applicable.
- Coverage evaluationAssessment support for the antibody coverage required by the project.
Development scope, materials and verification requirements are agreed for each project.
Start with your host.
Account for your matrix.
A host name is only part of the brief. The sample's process stage and intended use help define the assay-development work.
- Host systems
- CHO · HEK293 · E. coli · Yeast
- Samples
- Clarified harvest
- Protein A eluate
- Process intermediates
- Drug substance
- Testing goals
- Process monitoring · Release testing · Comparability · Technical transfer
From the project brief
to a custom kit
Explore the activities included in each development track. The project plan defines the materials, evaluation work and supply requirements.
Bring these details
to the first discussion
- HCD, HCP or both
- Host system and process stage
- Sample matrix and intended use
- Existing method and project goals
Define targets & requirements
Establish the host system, sample context and analytical objective.
- Requirement analysis
Define the intended use, host system and sample matrix.
- Literature & regulatory review
Review the context relevant to the proposed assay.
- Sequence conservation & specificity
Assess the target region for the intended host system.
Develop & verify the assay
Build the qPCR system and evaluate its performance.
- Primer/probe design & synthesis
Develop the target-specific detection reagents.
- Reference-standard preparation
Prepare the standard used for assay development.
- Optimization & performance verification
Evaluate assay conditions, background and matrix compatibility.
Plan stability & delivery
Prepare the developed kit for its agreed use.
- Stability study & delivery
Include the stability work and delivery requirements agreed for the project.
HandoffThe developed qPCR kit in the agreed configuration, with the COA, MSDS and IFU documentation package.
Prepare antigens & antibodies
Develop the biological materials for the HCP assay.
- Antigen preparation
Prepare antigen material relevant to the host or process.
- Animal immunization
Include immunization within the selected antibody-development strategy.
- Antibody generation
Generate the antibodies used for kit development.
Develop & evaluate the kit
Bring the antibody reagents into the ELISA system.
- ELISA kit development
Develop the assay configuration around project requirements.
- Kit verification / validation
Evaluate the agreed performance characteristics.
- Coverage evaluation
Include coverage assessment in the kit evaluation plan.
Manufacture the kit
Prepare the agreed kit configuration for supply.
- Kit manufacturing
Manufacture the developed kit under the agreed quality and supply requirements.
HandoffThe manufactured HCP ELISA kit in the agreed configuration, with batch traceability and the COA, MSDS and IFU documentation package.
Activities are grouped here for clarity. The detailed sequence, coverage work and verification criteria are defined in the agreed project plan.
Evaluate performance
in the intended application
Define the validation characteristics and acceptance criteria before interpreting the assay's performance in your samples.
| Characteristic | Evaluation focus |
|---|---|
| Sensitivity | Limit of detection (LOD)Assess the sensitivity needed for the intended application. |
| Precision | Within and between assaysEvaluate repeatability and between-assay variability. |
| Specificity & interference | Target and interference responseAssess the intended response and relevant interference. |
| Linearity & range | Working measurement rangeEvaluate response over the agreed analytical range. |
| Recovery & matrix effects | Representative process samplesAssess recovery and the influence of the sample matrix. |
| Suitability & stability | Controls and stabilityInclude system-suitability and stability checks within the agreed scope. |
Validation planning follows ICH Q2 principles. The characteristics, study design and acceptance criteria depend on the intended use and agreed project scope.
Define the handoff
as well as the assay
Agree the kit configuration, supporting documents and supply arrangements within the project scope.
Custom kit configuration
An HCD qPCR or HCP ELISA kit developed for the agreed host, matrix and analytical objective.
Supporting documentation
COA, MSDS and IFU materials included in the agreed documentation package.
Quality & traceability
QA/QC review and batch traceability supporting the supplied kit.
Ongoing supply planning
Manufacturing and longer-term supply requirements considered for routine kit use.
Questions about
HCD & HCP development
Choose the right track and prepare a useful project brief.
How do HCD and HCP assay development differ?
HCD development targets residual host cell DNA using qPCR. HCP development targets host cell proteins using ELISA. The two tracks address different impurity classes, so the appropriate assay depends on what you need to measure.
Which expression systems and sample types can be considered?
The service covers examples including CHO, HEK293, E. coli and yeast, and process samples such as clarified harvest, Protein A eluate, intermediates and drug substance. The final scope depends on your host system, process stage and sample matrix.
What should we include in the first enquiry?
Include the expression host, whether you need HCD or HCP testing, the sample type and process stage, and the intended use: process monitoring, release testing, comparability or technical transfer. Also describe any existing method and your target timeline so these can be considered during project scoping.
How long does a custom HCD or HCP project take?
The timeline depends on the track and scope: whether new antibody development is required (HCP), the host system and sample matrix, the validation characteristics agreed for the intended use, and the kit configuration and documentation required. A project-specific timeline is defined during scoping.
Can the project include an HCP antibody coverage evaluation?
Yes. Coverage evaluation support is included in the HCP customization scope. The antibody strategy, relevant antigen material and coverage work are defined for the host-specific or process-specific project.
What validation and documentation can be included?
The validation scope can cover sensitivity, precision, specificity and interference, linearity and range, recovery and matrix effects, with suitability and stability work as agreed. Quality support includes QA/QC review, batch traceability, and a documentation package such as COA, MSDS and IFU.
Tell us about your host system and sample.
Share the impurity you need to measure, your process stage and testing goals to begin a technical discussion.
Frequently Asked Questions
How do HCD and HCP assay development differ?
HCD development targets residual host cell DNA using qPCR. HCP development targets host cell proteins using ELISA. The two tracks address different impurity classes, so the appropriate assay depends on what you need to measure.
Which expression systems and sample types can be considered?
The service covers examples including CHO, HEK293, E. coli and yeast, and process samples such as clarified harvest, Protein A eluate, intermediates and drug substance. The final scope depends on your host system, process stage and sample matrix.
What should we include in the first enquiry?
Include the expression host, whether you need HCD or HCP testing, the sample type and process stage, and the intended use: process monitoring, release testing, comparability or technical transfer. Also describe any existing method and your target timeline so these can be considered during project scoping.
How long does a custom HCD or HCP project take?
The timeline depends on the track and scope: whether new antibody development is required (HCP), the host system and sample matrix, the validation characteristics agreed for the intended use, and the kit configuration and documentation required. A project-specific timeline is defined during scoping.
Can the project include an HCP antibody coverage evaluation?
Yes. Coverage evaluation support is included in the HCP customization scope. The antibody strategy, relevant antigen material and coverage work are defined for the host-specific or process-specific project.
What validation and documentation can be included?
The validation scope can cover sensitivity, precision, specificity and interference, linearity and range, recovery and matrix effects, with suitability and stability work as agreed. Quality support includes QA/QC review, batch traceability, and a documentation package such as COA, MSDS and IFU.
