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

Highly sensitive HCP assays are increasingly important for proving drug purity and finally drug approval. BioGenes has over 12 years experience in the development, validation and production of HCP assays covering a broad spectrum of antigens in different cell lines. Our renowned customers include Rentschler, Novartis, Sandoz, Merckle.

BioGenes offers the development , validation and production of

• Generic HCP assays
• Multiproduct HCP assays
• Product-specific HCP assays

 
BioGenes’ services include:

• Adaptation of HCP assays to customer’s processes
• Project design 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’s requirements and ICH guidelines (ICH Q2B)
• Production of the immunoassay
• Technology transfer to the customer – SOPs and training of the staff
• GMP compliant release tests
• Stability and performance tests according to the customer’s requirements
• Production of complete kits or assay components
• Documentation according to regulatory guidelines

Please contact us for more information.