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Host Cell Protein (HCP)

Our team is uniquely skilled to offer first-class immunoassay development and analytical services for the detection and/or quantification of process-related contaminants, including host cell proteins.

GTP Bioways CDMO - Formulation Development

Expertise with custom immunoassay development for bioprocess impurities

GTP Bioways is a recognised expert in process-related impurities detection, and especially in host cell proteins (HCP) risk management. Drawing on our 20 years’ experience developing bioprocesses with a diversity of expression systems, we can advise you on the most effective strategy for the detection and characterisation of process-related impurities from the earliest stages of your project.

Our expertise spans all prominent expression systems used to manufacture therapeutic monoclonal antibodies and recombinant proteins and other complex biologics, including CHO, E.coli, HEK293, Pichia pastoris, insect cells and algae.

Webinar

Everything you always wanted to know about host cell proteins!

Get the chance to learn more about HCP risk management during our next webinar. We wil share our expertise over different case studies.

Why is it important to consider HCP contamination from early project stages?

By using a commercial host cell protein (HCP) ELISA kit during the first stages of your project, you may fail to detect and thus reduce HCP during drug development. The potentially biased quantification of HCPs and process-related contaminants may delay your project.

Despite only being required by regulatory bodies during late clinical phases, at GTP Bioways we propose to bring forward HCP ELISA validation to mitigate associated risks for your project and avoid project stand-by.

Comprehensive services to validate your HCP ELISA kit

HCP risk management is involved at two critical development and manufacturing stages of your project:

  • During process development and process validation to obtain relevant and specific data to improve downstream process development and further decrease HCP contamination
  • During final product quality control

Prior to those steps, you will have to demonstrate the dilutional linearity of your HCP ELISA kit and assess the coverage of the antibodies for both process samples and the final biopharmaceutical product.

GTP Bioways has developed a strong expertise to assist you in the selection of the commercial HCP ELISA kit that best suits your project. If none of the commercial HCP ELISA kit fits your needs, our team can develop a process-specific HCP ELISA kit.   

A complete development and manufacturing solution for your biopharmaceuticals
HCP ELISA Specific flow chart - GTP Bioways CDMO

Process-specific HCP ELISA kit development and manufacturing

If no commercial kit is suitable for your project or when your project is ready to move to clinical phase, our team offers process-specific HCP ELISA development services:

Process specific HCP ELISA development - GTP Bioways CDMO

GTP Bioways provides a wide range of analytical services dedicated to your biotherapeutics

We have the expertise to support the development of your biotherapeutics with our cutting-edge analytical & formulation services.

Analytical services

We offer expert analytical services dedicated to process development and GMP manufacturing.

Custom ELISA

We are experts in the development and manufacturing of custom immunoassays based on your requirements.

Formulation

Our seasoned team offers dedicated formulation development suitable to your specific biomolecule.