Analytical caracterisation services

At Rodon Biologics, we are committed to providing high-standard analytical services that support the development and commercialization of biologics. With years of experience, we develop tailored analytical procedures to ensure the consistent quality of products and processes throughout their lifecycle.

Importance and Applications

Characterisation is essential in biotechnology, pharmaceuticals, and medicine, providing critical insights into biomolecules like proteins. These insights help to:

• Determine protein structure and function
• Identify impurities and contaminants
• Optimize formulation and stability
• Develop quality control methods
• Support regulatory submissions

These data are vital for developing safe and effective biopharmaceutical products that meet regulatory standards and perform as intended in clinical settings.

Expert Support for Biologics Development

Our team of specialists offers robust analytical support throughout biologics development, from discovery to clinical trials and beyond. We design tests based on the latest pharmacopoeial standards (EU and US monographs) and follow global regulatory guidelines like ICH, FDA, and EMEA. This approach ensures our clients' biologic products meet the highest standards of safety and efficacy.

By combining expertise in protein biochemistry, molecular biology, and cellular biology, we provide an integrated approach to biologic characterization. Additionally, we collaborate with trusted partners specializing in advanced characterization methods to offer a full range of services necessary for successful biologic therapeutics development.

Comprehensive Characterisation Services

We specialize in a variety of analytical techniques to support biologics characterization:

• Protein Concentration: We use A280, HPLC, and ELISA for accurate protein quantification, ensuring precision and reproducibility in biologic formulations.
• Protein Purity Analysis: Using SDS-PAGE, HPLC, DNA-qPCR, HCP ELISA, and Endotoxins assays, we assess protein purity to detect potential contaminants that could affect safety or stability.
• Identity Testing: We confirm product identity using techniques such as peptide fingerprinting, Western blotting, mass spectrometry, and CD (Circular Dichroism) to provide a detailed product profile.
• Potency Assays: We assess biological activity through ELISA, flow cytometry, SPR, and cell-based assays to ensure the therapeutic product performs as intended.

Why Choose Rodon Biologics?

At Rodon, we understand the complexities of biologics development and are committed to providing reliable, timely, and high-quality analytical services. Our comprehensive testing capabilities support biologic characterization at every stage, helping our clients meet regulatory standards and achieve market success.