Host Cell Protein Antibody Generation

Host Cell Protein Antibody Generation

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Host Cell Protein Antibody Generation

INQUIRY

Creative BioMart provides customized services for the generation of specific host cell protein antibodies to meet the specific needs of our customers in kinase/phosphatase biology research and biopharmaceuticals. As a leading biotechnology company with many years of experience in antibody production, we can offer comprehensive services from antigen preparation to antibody analysis.

Background

Host cell proteins (HCPs) are a heterogeneous, complex group of either secreted proteins or intracellular proteins produced by the host cells during the production of recombinant therapeutic proteins. While a majority of produced HCPs are removed from the final product during the purification process, any residual HCP, even at low levels, have the potential to compromise the safety and efficacy of biopharmaceuticals. To meet clinical applications, regulations require reduction of HCPs to the lowest levels possible. Therefore, the detection and elimination of HCPs during the purification of biotherapeutics is very important and necessary.

With the rapid growth of biologics production, the requirements for identification and evaluation of residual HCPs are expanding. However, the removal of HCPs is one of the biggest challenges in biopharmaceutical production. The amount and composition of residual HCP are unique to their respective host, which makes the quantification and characterization of HCPs more difficult. In order to detect the presence of residual HCPs in final biopharmaceutical products, custom reagents with maximum coverage and sensitivity against HCPs are required to be developed. Anti-HCP antibodies are valuable and the most commonly used tools to detect and assess HCPs. Evaluation and validation of anti-HCP antibodies is a crucial step for effective monitoring residual HCPs to demonstrate product purity in process development and quality control.

The risk assessment continuum is presented in the context of biopharmaceutical process development.

Figure 1. The risk assessment continuum is presented in the context of biopharmaceutical process development. (Bracewell D G, et al., 2015)

Service Options

Creative BioMart offers our extensive experience, advanced technology, and a comprehensive set of customized services to maximize the chance to generate highly specific and reproducible antibodies with maximum coverage against native HCPs within a short period of time. We will do our best to optimize the custom project to accommodate your needs.

Applications
Western blot 2D Western blot ELISA
Available Options
Anti-E.coli HCP antibody Anti-E. coli HMW HCP antibody Anti-E.coli LMW HCP antibody
Anti-E.coli HCP combined antibody Anti-CHO HCP antibody Anti-HEK293 HCP antibody
Anti-Vero cell HCP antibody Anti-P. fluorescens HCP antibody Anti-P. pastoris HCP antibody
Anti-S. cerevisiae HCP antibody Anti-A549 HCP antibody Anti-Human HCP antibody
Host Animals
Rabbit Goat Sheep
Donkey Chicken Customer requested species
Additional Services
Bulk production HCP assay development Antibody conjugation

If you can't find what you are looking for in the options above, please fill out the online inquiry form and let us know more details.

Standard Service Process

Standard Service Process

Highlights

Highlights

Creative BioMart provides comprehensive and flexible custom HCP antibody generation services to meet the individual needs of our customers. Our advanced technology platform coupled with a large product portfolio has enabled us to successfully complete numerous challenging projects, helping our customers save time and effort. If you are interested in our services or products, please do not hesitate to contact us.

References

  • Bracewell D G, et al. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk‐based management for their control. Biotechnology and bioengineering, 2015, 112(9): 1727-1737.
  • Vanderlaan M, et al. Experience with host cell protein impurities in biopharmaceuticals. Biotechnology progress, 2018, 34(4): 828-837.
For research use only. Not intended for any clinical use.