Introduction
The use and number of biotherapeutics has increased significantly in recent years. For these protein-based
therapeutics, the quantification of impurities is of particular concern due to their potential impact on efficacy
and immunogenicity. Variation of low-level impurities in therapeutic proteins is a common challenge throughout the
biopharmaceutical pipeline—it can negatively impact the stability, safety, and efficacy of protein therapeutics. On
the one hand, impurities may interact with the therapeutic protein in a manner that blocks and/or impairs the
activity and potency of the therapeutic protein in the body, thereby reducing its efficacy. On the other hand,
impurities may exaggerate or enhance the biological activity of therapeutic proteins in an uncontrolled manner,
leading to adverse events. Some impurities (especially host cell proteins) may add immunostimulatory or adjuvant
actions to the therapy, leading to the development of antibodies or cell-mediated immunity against the protein in
the patient. Therefore, it is especially important for biopharmaceutical companies to accurately analyse the purity
of therapeutic proteins.
Our Services
A biopharmaceutical purity analysis will confirm your product's purity (i.e., identify any unwanted impurities).
It is a regulatory requirement to provide complete data to confirm the identity and purity of your
biopharmaceutical, whether it is a peptide, protein or glycoprotein.
As a global protein sequencing and mass spectrometry service provider, Creative Proteomics has been
providing comprehensive analytical support for biopharmaceuticals. The laboratory is equipped with high-performance
liquid chromatography-high-resolution mass spectrometry, which can accurately identify the position and relative
quantity of various modifications. The many protein characterization methods that our highly qualified scientists
will employ in characterization studies provide comprehensive analytical data to confirm identity and purity, as
well as to assess another structural or physicochemical characteristic.
Based on high-resolution mass spectrometry technology, Creative Proteomics provides a series of
complete biopharmaceutical purity analysis solution services for global researchers, including but not limited to:
LC-MS Based Host
Residual Protein Analysis Service
Host residual protein (HCP) is derived from host cells or cell culture fluid, the existence of which may lead
to unstable efficacy of drug products, immune response of patients, etc. Qualitative and quantitative
analysis of HCP proteins based on LC-MS technology inaccurate qualitative and quantitative results due to
lack of antibodies in the ELISA method can be avoided.
Chemical
Cross-Linking Mass Spectrometry Analysis Service
Chemical cross-linking mass spectrometry is a new method developed in recent years. It uses chemical
cross-linking agents to treat protein samples, and covalently links two amino acids that are close enough in
space to react with cross-linking agents, then analysing cross-linked products by proteomics approach based
on mass spectrometry.
Why Choose Us?
- Comprehensive and systematic analysis platform.
- Professional advices.
- Advanced Mass Spectrometry equipment.
- Quick turnaround time.
- Customized service.
- Excellent after-sales service.
Creative Proteomics provides comprehensive and systematic biopharmaceutical characterization
services to meet regulatory requirements for global biopharmaceutical characterization. With our advanced analytical
platforms and professional bioscientists, we can provide our customers with a series of biopharmaceutical purity
analysis services. In addition, our expert team can also provide the most economical and professional customized
solutions according to your requirements. Please contact us without any
hesitation If you are interested in our services.
