Biosimilars Testing

At PharmaPrimes Laboratories, we offer a wide range of specialized services to meet the diverse needs of our clients in the pharmaceutical and biotechnology sectors. Our services include:

1. Biosimilarity Assessment: We provide thorough and detailed biosimilarity assessments, focusing on critical quality attributes essential for regulatory approval. Our expertise includes:
   • Purity/Impurity Profile and Charged Variants Analysis: Utilizing Ultra-Performance Liquid Chromatography (UPLC) and Capillary Electrophoresis (CE), we deliver in-depth analyses of purity levels and charged variants to ensure your biosimilar matches the reference biologic in terms of quality and consistency.
   • Glycosylation Analysis: Advanced High-Resolution Mass Spectrometry (HRMS) and Capillary Electrophoresis (CE) techniques are employed to assess glycosylation patterns, a crucial quality attribute that affects the biological activity, stability, and immunogenicity of biosimilars.
   • Potency and Functional Assays: We perform comprehensive assays using Surface Plasmon Resonance (SPR), and Enzyme-Linked Immunosorbent Assay (ELISA) Systems to evaluate the biological activity and therapeutic potential of biosimilars, ensuring they deliver the intended clinical outcomes.
   • Primary Structure Analysis: Our detailed analysis of the amino acid sequence of biosimilars is supported by Nuclear Magnetic Resonance (NMR) Spectroscopy and Mass Spectrometry-based Proteomics Platforms, ensuring consistency with the reference biologic.
   • Higher-Order Structure Analysis: We utilize Circular Dichroism (CD) Spectrometry, Differential Scanning Calorimetry (DSC), X-ray Crystallography, and Fourier Transform Infrared (FTIR) Spectroscopy to assess the three-dimensional conformation of proteins, confirming that the biosimilar maintains the same structural integrity as the reference product.
   • Protein Modifications: Using High-Resolution Mass Spectrometry (HRMS), Size Exclusion Chromatography (SEC-HPLC), and Nuclear Magnetic Resonance (NMR) Spectroscopy, we analyze post-translational modifications to verify that your biosimilar retains the necessary functional properties and stability.
2. Batch Release for Fill and Finish Products: Our batch release services ensure that your fill and finish products are evaluated and approved for market release, adhering to the highest standards of quality and compliance.
3. Stability Studies: We conduct comprehensive stability studies using advanced techniques to determine the shelf life and optimal storage conditions for your products, ensuring they maintain their quality and efficacy over time.
4. Bioanalysis of Pre-Clinical and Clinical Samples: Our bioanalytical services support both pre-clinical and clinical phases, offering precise quantification and analysis of biological samples across a variety of matrices, using cutting-edge instruments like LC-MS/MS and Flow Cytometry.
5. Methods Development and Validation: We specialize in the customized development and rigorous validation of analytical methods, using state-of-the-art equipment tailored to meet the specific needs of your project and comply with international guidelines.
6. Partnerships: We collaborate closely with our clients to form strategic partnerships, offering tailored solutions that support every stage of drug development and ensure successful regulatory submissions.