One-stop Solutions for Biosimilar Testing

About One-stop Solutions for Biosimilar Testing

A biosimilar is a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. However, biosimilars may be sensitive to tiny changes in manufacturing processes because of their high molecular complexity. So the quality requirements are critical for the development of biosimilars. These requirements are needed to generate evidence demonstrating the similar nature concerning the biosimilar product's quality, safety, and efficacy to the innovator product.The development of biosimilars in particular requires extensive analytical comparisons of drug structure and function to ensure biosimilarity to the reference product, so you need a partner with experience and knowledge in biosimilar assay design and effective research methods and a robust characterization tool. CD Formulation's scientists have been provided a one-stop solutions for biosimilar testing, and we understand the complex process required to fulfil the regulatory requirements. We provide a comprehensive range of structural, biophysical and physicochemical characterization methods drawing on years of technical expertise and product insight to tailor these to your needs.

Application and Advantage of Biosimilar

Biosimilar has been widely used in the world and shown obvious clinical advantages in the treatment of some diseases, such as digestive, infection, endocrine, cardiovascular, cancer, rheumatology and other therapeutic areas. The development of biosimilar has many advantages, such as the price is more affordable, the approval of the market is faster, increase patients' access to treatment and reduce patients' individual treatment costs.

Our Biosimilar Testing Capabilities

CD Formulation is highly experienced in performing comparability studies and in the analysis of biosimilar products in accordance with ICH Q6B. We provide one-stop solutions for biosimilar testing, ranging from determining the exact sequence, structure and quality attributes of the originator to comparative head-to-head biosimilarity testing of the biosimilar with the originator, we use a variety of technical analysis methods to quickly and accurately characterize parameters and accelerate biosimilar development.

• Structural Characterization Services

• Primary amino acid sequencing
• N and C terminal sequencing
• Amino Acid Analysis
• Extinction coefficient determination
• Peptide mapping
• Disulfide bridge analysis
• Intact molecular weight
• Monosaccharide analysis
• Oligosaccharide analysis

• Technologies Used

• Imaged capillary isoelectric focusing (icIEF)
• Capillary electrophoresis sodium dodecyl sulfate (CE-SDS)
• Liquid chromatography coupled mass spectrometryCircular Dichroism(LC-MS)
• Fourier Transform Infrared Spectroscopy (FTIR)
• Intrinsic/ Extrinsic Fluorescence
• micron-scale differential scanning calorimeter (µDSC)
• Multi-angle light scattering coupled with size exclusion chromatography (SEC-MALS)
• Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC)
• 1D and 2D NMR

Advantages of Our One-stop Solution for Biosimilar Testing Services

• We have professional biosimilar drug analysis and testing technology teams, which can provide one-stop solution for biosimilar testing and full project management services.
• We can achieve competitive pricing.
• Our one-stop service reduced human resources and operating costs, accelerate the development of your biosimilars.
• Our one-stop service is convenience and speed, and including all the raw data and complete reports for testing.

How to Contact Us?

If you have any biosimilar analysis requirement, please contact us by phone or email, our colleagues will reply to you within three working days.