Advances in the life sciences industry have led to the creation of life-changing therapeutics that transform human health. A critical aspect of therapeutic development and manufacture is host cell protein (HCP) detection, quantitation, and removal from drug substances, to ensure efficacy and prevent immunogenicity. These processes require robust technologies that deliver integrated performance, backed by trusted expertise. As a global provider of technologies and services that advance and accelerate the development and manufacture of novel therapeutics, Cytiva offers a range of solutions to support scientists and developers in creating an effective strategy for HCP control.
End-to-end solutions for HCP analysis
Living systems, including microorganisms, are used as cellular factories for biologics production. These systems also produce endogenous proteins (HCPs), which can have significant implications for the efficacy, toxicity, and immunogenicity of the final drug product, and must be removed during manufacture. As such, there are numerous regulatory guidelines pertaining to HCP detection and removal from drug products.
Each host cell line expresses a unique signature of proteins that are, affected by culture conditions, including temperature, acidity, nutrient supply, and other factors. Therefore, it is critical to employ assays to detect the product’s unique combination of HCPs. Subsequently, developers must implement appropriate downstream purification processes to reduce HCP content and ensure product safety and efficacy. The enzyme-linked immunosorbent assay (ELISA) is considered the gold standard method for HCP quantitation, as it offers high sensitivity and selectivity required to detect the complex mixture of an HCP population. ELISAs are also amenable to automation to support high-throughput analyses.
Biologics developers and manufacturers require highly accurate and reliable ELISAs to ensure product integrity. Cytiva solutions are designed to detect and quantify HCPs in process-derived samples harvested from Chinese hamster ovary (CHO) cell lines, and overcome many of the limitations of existing assay products.
The highly sensitive antibody with strong HCP coverage minimizes undetected HCPs. Further, consistently low inter- and intra-plate variation ensures reproducible data. The combination of wide dynamic range, strong dilutional linearity and sensitive antibody with strong HCP coverage ensures appropriate coverage of the complex HCP population and minimizes undetected proteins.
This in turn reduces the risk of immunogenicity associated with HCPs in process-derived samples. Cytiva HCP solutions give you confidence in your results.
While ELISA is the gold standard approach for HCP detection and quantification, even the most robust assay still fails to provide 100% coverage of all HCPs. As such, various regulatory bodies require manufacturers to validate the assays they use. Data in Figure 1 shows that different HCP ELISA kits provide different HCP values even on already approved biologics. It is critical to choose a suitable ELISA kit for your samples using careful validation of the ELISA.
As part of the end-to-end solutions for HCP analysis, Cytiva also offers solutions for 2D differential in blot electrophoresis (2D-DIBE) for its coverage assay. Using fluorescent multiplexed methodology, 2D-DIBE overcomes the challenges associated with 2D gel electrophoresis and colorimetric Western blot.
Human at the core
In the life science industry, breakthrough therapeutics are the result of hard work and compassion, among individuals and teams driven by a powerful desire for new discovery. Cytiva sees the possibilities for more discovery, greater speed, and fewer setbacks, and provides the technology, expertise, and support necessary to achieve superior results.
Being inspired by the impact of novel therapeutics on patient lives, Cytiva sees the bigger picture and has developed advanced solutions to push the pace and expand the boundaries of modern therapeutics. These solutions are based on high-performing technologies as the gold standard, which produce high-quality data that is easily translated into actionable insights.
With a reputation for delivering high-quality products for purification of monoclonal antibody therapeutics like MabSelect PrismA and MabSelect SuRe purification resins, customers can trust Cytiva solutions will enhance their research. Cytiva has experience supporting biopharmaceutical customers in all upstream and downstream processes with resins, cell culture media, and other advanced solutions, and is proud to now enhance HCP control strategies with ELISAs, antibodies, software, and imaging systems. As a trusted long-term partner, Cytiva ensures reliable data and the security of supply essential for efficient drug development.
In addition to providing robust technological solutions, Cytiva serves as a knowledgeable and reliable partner throughout every step of the process. With a foundation of scientific expertise and an application-focus, Cytiva provides collaborative, tailored approaches to support every customer’s unique needs and transform a vision into reality.
Laboratory personnel face high workloads, and are under pressure to create robust, reproducible HCP assays to finalize projects with confidence. Having to balance assay standards, time, costs, regulatory requirements and tools accessibility is challenging, and Cytiva provides expert support to eliminate the risk of assay redesign. This expertise is also critical to manage complexities and adapt to customers’ ever-changing pipelines, as well as to develop insights into future challenges and opportunities within the life sciences.
Above all, the Cytiva team is human at the core, and has the ability to understand each customer’s goals and priorities. This understanding forms the foundation relationships with customers and partners to advance and accelerate therapeutics that transform human health.
Learn more at cytiva.com/hcp