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 * Title Company * Email * Date of antigen availability * What species is your host cell? * -Select- CHO Vero Murine E. coli HEK293 MRC5 Other Is your Antigen BSL 1? * -Select- Yes No Please provide additional information * Would you like to perform antigen fractionation (i.e. generation of low molecular weight fraction)? -Select- Yes No What animals to be used for immunization (select all that apply)? * To select multiple animals, please hold the <ctrl> key while selecting. Goat Rabbit Chicken eggs Is ELISA (end-point assay) development required? * -Select- Yes No Is ELISA (end-point assay) Validation required? * -Select- Yes No Would you like a Client-Specific Method Transfer to be available? * -Select- Yes No Do you require Long Term Storage of antisera and/or antibody? * -Select- Yes No 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. I agree. * required W - Weeks Start date End date Antigen availability Antigen selection and generation Antigen concentration/fractionation 4 Antigen qualification/characterization 1D SDS-PAGE, 2D SDS-PAGE, or Bradford assay 2 Immunization Testing of pre-immune serum of each animal 4 Immunization 16 Testing of raw serum/purified antibody 4 Antibody Characterization Purification of antisera 4 Antibody characterization 4 Preparation of reference standard 2 Assay Development and Testing End point assay development 8 Assay Validation 8 Routine testing 4 Completed Start date End date * Charles River is not committing to these dates at this time. Please contact us to confirm actual milestone dates. ** Some timelines may be expedited, based on your selected conditions. firstname.lastname@example.org www.criver.com © 2020 Charles River Laboratories International, Inc.