Biologics Host Cell Protein

The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. The development of a downstream process with the use of effective assays to determine both the concentration of the product and the quantity and concentration of host cell proteins present is essential in determining the safety of a product. Once a biopharmaceutical is used in Phase III clinical studies, a validated, product-specific HCP assay is usually required. Use the timeline generator below to find out how long it will take for the development and validation of a custom host cell protein bioassay for your product. Please note this tool is meant to provide an estimated timeline to help you better plan for your HCP testing.
First Name *
Last Name *
Company *
Email *
Date of antigen availability *
What species is your host cell? *
Is your Antigen BSL 1? *
Would you like to perform antigen fractionation (i.e. generation of low molecular weight fraction)?
What animals to be used for immunization (select all that apply)? *
To select multiple animals, please hold the <ctrl> key while selecting.
Is ELISA (end-point assay) development required? *
Is ELISA (end-point assay) Validation required? *
Would you like a Client-Specific Method Transfer to be available? *
Do you require Long Term Storage of antisera and/or antibody? *
Yes, I would like to receive email communications from Charles River and allow for my information to be used for any follow-up requests to identify potential products or services relevant to my needs.
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