Customised Host Cell Protein (HCP)-Assays for Quality Control

BioGenes supports you with high sensitive HCP assay development for quantitative determination of contaminants:

• Optimisation and validation of commercially available generic HCP assays
• Development and validation of generic assays for customer specific standard cell lines and downstream processes
• Development, validation and production of specific HCP assays for optimised cell lines and processes

 BioGenes’ full service offer includes:

• Project design: Determination of the crucial points of an HCP assay and preparation of a project plan
• Antigen preparation and validation
• Development of suitable antibody pairs
• Development of HCP assay in the working matrix or matrices
• Validation of HCP assay according to customer requirements and ICH guidelines (ICH Q2B)
• Production of the immunoassays
• Technology transfer to the customer – SOPs and training of the staff
• Performance of HCP determinations during the process development and in the quality control process of the final product (GMP compliant release tests)
• Manufacturing of complete kits or assay components  

Additional services include stability tests and further performance tests according to the customer’s requirements. The documentation provided by BioGenes is prepared according to regulatory guidelines. Please contact us for more information.