Analytical Testing & Methods Development

Apurun delivers top-tier, comprehensive analytics encompassing a full panel of nanoparticle analysis, including Lipid Nanoparticles (LNP), Polymeric, and Hybrid types. Our services excel in methods development, validations, and testing for both GMP and Non-GMP applications.

Dynamic Light Scattering (DLS)

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Apurun provides comprehensive services for Dynamic Light Scattering (DLS) aimed at size, charge, and nanoparticle characterization to support quality control measures for lipid nanoparticles (LNPs) and liposomal drug products, in accordance with FDA guidelines. Here's a summary of Apurun's offerings: 1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust DLS methods tailored for size, charge, and nanoparticle characterization. These methods are designed to meet FDA guidelines, ensuring accuracy and reliability in assessing critical parameters. 2) Method Validation: Apurun conducts thorough validation studies to demonstrate the accuracy, precision, and robustness of the developed DLS methods. This validation process ensures compliance with FDA requirements and enhances confidence in the generated data. 3) Testing Services: Apurun offers testing services utilizing validated DLS methods for LNPs and liposomal formulations. These tests provide comprehensive characterization of nanoparticle size distribution, zeta potential, and other relevant parameters essential for quality control. 4) Quality Control: Apurun's testing services contribute to quality control efforts by providing accurate assessments of nanoparticle characteristics. Monitoring size, charge, and other properties ensures product consistency, stability, and efficacy as per FDA guidelines. 5) Regulatory Compliance: Apurun's services are aligned with FDA regulations, facilitating regulatory compliance for pharmaceutical products. By adhering to standardized protocols and best practices, Apurun assists companies in meeting regulatory requirements and obtaining product approvals. Overall, Apurun's expertise in DLS-based size, charge, and nanoparticle characterization supports pharmaceutical companies in ensuring the quality, safety, and regulatory compliance of LNPs and liposomal drug products.

Encapsulation Efficiency (EE%)

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