Immunology services
Anti-host cell protein antibodies
Bioproduction processes use a variety of host cells (bacterial, yeast, mammalian, insect or plant cells) to produce the biotherapeutic protein of interest, but contaminating proteins derived from the expression system are also produced.
These protein contaminants, called host cell proteins (HCPs), are residual protein impurities that potentially reduce the quality and efficacy of the biotherapeutic product, as well as patient safety.
Regulatory authorities require these HCPs to be monitored and quantified using a gold-standard method, the sandwich ELISA.
Agro-Bio offers a comprehensive HCP solution for bioproduction projects.
Optimized solutions for host cell protein (HCP) detection
We offer a complete, custom solution to your HCP issues:
- Selection and qualification of generic HCP ELISA kits: dilutional linearity, specificity, coverage, LOD/LOQ,
- Bulk production of anti-HCP antibodies (rabbit, goat, chicken) or optimized immunization protocols on SPF (specific-pathogen-free) animals,
- Suitable purification processes: protein A/G or affinity purification (specific anti-HCP polyclonal antibodies),
- Validation of anti-HCP antibodies: coverage analysis using 2D gel electrophoresis/western blotting, 2D-DIBE, immunoaffinity extraction,
- Development and qualification (in accordance with ICH guidelines) of specific HCP ELISA assays (kits),
- Design of ready-to-use ELISA kits and quality control.
Our service also includes secure storage of the sera and antibodies produced, as well as monitoring of the stability of these critical reagents and ELISA kits.
Biopharma
- Audit & confidentiality agreement
- Traceability
- Ensuring compliance with authority regulatory requirements
- Quality control