Do you know how long it will take for the development and validation of a custom host cell protein (HCP) bioassay for your product?
Our new Host Cell Protein Timeline Generator creates an estimated timeline, so you can keep your drug development program on track.
Even a small amount of host cell proteins (HCPs) in a final drug product can produce an immunogenic reaction; therefore, the product and process intermediates need to be tested for their presence.
Traditional protein detection methods, such as HPLC and total protein stains, do not have the sensitivity or specificity used in HCP detection. Instead, optimized immunoassays (ELISA) and mass spectrometry (MS) methods are more suited to measure and characterize HCPs.
In early phases of development, generic, commercially available kits are acceptable for testing HCPs, but a validated, product-specific HCP assay is required once a biopharmaceutical reaches a Phase III clinical trial.
Developing these product-specific assays is a time-consuming process involving multiple steps, including antisera production, purification of antibodies, and ELISA assay set-up and optimization, qualification, and validation.
Take Control of Your Timeline
When you know your timeline, you can optimally manage your projects. Our Host Cell Protein Timeline Generator can help you keep your drug development work on track.
- The tool generates a GANTT chart based on your selected parameters and allows you to export your timeline.
- Our fast track option offers an expedited pathway which can be used to reduce the overall assay development timeline by up to three months.
- There's no need to reserve a spot for your assay. Our global reach enables us to immediately accommodate requests for validated product-specific HCP assays.
If you have any questions regarding our HCP services and/or our HCP planner, our team is ready to assist you.