Unlocking the Power of Conbercept Ophthalmic Injection: Evaluation for Safety and Efficacy

CD BioGlyco has an efficient Pharmaceutical and Biological Analysis team to analyze and evaluate Pharmaceutical, Biological, and Pharmaceutical Excipient and provides customized solutions to meet clients' multiple needs. Conbercept ophthalmic injection is made from a recombinant fusion protein produced using the Chinese hamster ovary (CHO) cell expression system of the human vascular endothelial growth factor receptor-antibody fusion protein gene.

• Conbercept ophthalmic injection bulk analysis
  • Identification
    • Peptide mapping: Our team provides complete analytical services including pretreatment, protein-specific cleavage, peptide isolation and detection, result analysis, and determination. We use a C18 column to elute the sample and compare it with the standards.
    • N-Terminal sequence: Our staff determines the N-terminal amino acid sequence by an amino acid sequence analyzer or mass spectrometry (MS).
    • Molecular weight: Our staff uses reduced SDS polyacrylamide gel electrophoresis to determine the molecular weight.
    • Heterogeneity: Our researcher measures the samples and standards using isoelectric focusing, ion exchange chromatography, capillary isoelectric focusing (CIEF), and imaging capillary isoelectric focusing (IEF).
  • Purity and impurity
    • Purity: Our team uses high-performance liquid chromatography (HPLC) and reduced SDS-polyacrylamide gel electrophoresis to test the purity of the samples. All elution conditions and buffer concentrations are repeatedly tested by researchers to ensure optimal results.
    • Residue: We mainly provide accurate host cell DNA residue, host cell protein residue, and protein A residue analysis services. We analyze host cell DNA residues as determined by quantitative PCR. For host cell protein residue and protein A residue, we use enzyme-linked immunosorbent assay (ELISA) for analysis.
    • Protein content: We use Ultraviolet-visible (UV-Vis) spectrophotometry to determine the absorbance and calculate the protein content of the samples.
    • Sialic acid content: We use C18-HPLC for the separation and quantification of sialic acids.
  • Valency
    • Biological activity: Our team uses human embryonic kidney cells (HEK293) stably transfected with the vascular endothelial growth factor receptor 2 (VEGFR2) gene and luciferase reporter gene luc2P to determine the biological activity of conbercept ophthalmic injection by blocking the expression of VEGF-stimulated cellular luciferase differently at different concentrations of conbercept ophthalmic injection.
    • Relative binding activity: We use ELISA to assay the adsorption of different concentrations of conbercept on an enzyme-labeled plate of VEGF to determine the relative binding activity of conbercept ophthalmic injection.
  • Glycan profiling
    • We offer a full range of glycoform analysis services including PNGase F digestion, solid phase extraction (SPE), 2-aminobenzamide (2-AB) labeling, HPLC analysis, and glycoform analysis.
  • Bacterial endotoxin test
    • We use gel-clot, turbidimetric, or chromogenic methods to detect or quantify endotoxins from gram-negative bacteria.
• Conbercept ophthalmic injection final bulk analysis
  • Bacterial endotoxin test and sterility test: Our team provides professional and reliable bacterial endotoxin test and sterility tests to clients.
• Conbercept ophthalmic injection final product analysis
  • Identification
    • Molecular structure domain: We take the standard and the test material spot them on three membranes, and then add labeled anti-KDR antibody, anti-lt-1 antibody, and anti-IgG-Fc antibody for specific binding, respectively. We examine the antigenic specificity of the test samples using the dot immunobinding assay (DIBA).
  • Basic test
    • Heterogeneity
    • Protein content
    • pH
    • Bacterial endotoxin

    • Purity
    • Visible particle
    • Osmolality
    • Sterility

    • Biological activity
    • Relative binding activity
    • Weight variation
    • Abnormal toxicity
  • Sub-visible particle test
    • Our team uses light obscuration to determine the size and number of insoluble particles in injection solutions.
  • Content analysis
    • Polysorbate 20: After layering the injection with dichloromethane, we calculate the amount of polysorbate 20 by measuring the absorbance of the lower layer of the solution by UV-Vis spectrophotometry.
    • Arginine: We use reversed-phase (RP) HPLC to quantify the derivatized arginine.

Publication Data

Applications of Conbercept Ophthalmic Injection Evaluation

• Conbercept ophthalmic injection evaluation provides technical support for the analysis and evaluation of other ocular biologics.
• Conbercept ophthalmic injection evaluation helps develop more anti-VEGF drugs.
• Conbercept ophthalmic injection evaluation plays a key role in the design and expression of multi-target fusion proteins.

Advantages of Us

• Our advanced analytical systems automate complex operations to increase analytical efficiency. Automation reduces manual errors and saves time.
• All titration and analytical tests are repeated at least three times by our researchers to ensure minimal error.
• We provide not only the conbercept ophthalmic injection analysis data but also the raw plots, elution gradients, optimization steps and so on.

CD BioGlyco has many years of experience in biological evaluation. We have many years of successful experience in the evaluation of injection, immunoglobulins, and vaccines. We are committed to meeting all of our client's needs. Please contact us anytime, we're here to help.

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