Analytical Testing & Methods Development

Request for Methods Development & Validations

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)

Test Method

Classification

Total Number of Tests

$175.00

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%)

Test Method

Classification

Total Number of Tests

$175.00

Encapsulation efficiency (EE%) analysis is pivotal for lipid nanoparticles (LNPs) and liposomal drug products, determining the proportion of drug encapsulated within these delivery systems. Our specialized assays are meticulously developed and validated to accurately quantify EE%, ensuring reliability and compliance with regulatory standards. By offering comprehensive testing services, we provide precise measurements of drug loading efficiency, essential for optimizing formulation parameters and assessing drug delivery efficacy. Through rigorous quality control measures and adherence to regulatory guidelines, our EE% analysis supports pharmaceutical companies in ensuring product consistency, efficacy, and regulatory compliance in lipid-based drug delivery systems

1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust methods for assessing encapsulation efficiency. These methods are tailored to specific drug formulations and delivery systems, ensuring accurate and reliable results.

2) Method Validation: Apurun conducts comprehensive validation studies to demonstrate the accuracy, precision, and robustness of developed encapsulation efficiency assays. This validation process ensures compliance with regulatory requirements and enhances confidence in the obtained data.

3) Testing Services: Apurun offers testing services utilizing validated assays for encapsulation efficiency analysis. These services provide quantitative measurements of the amount of drug encapsulated within liposomes or nanoparticles, essential for optimizing formulation parameters and assessing drug delivery efficacy.

4) Quality Control: Apurun's encapsulation efficiency testing contributes to quality control efforts by providing accurate assessments of drug loading in nanoparticle formulations. Monitoring encapsulation efficiency ensures consistency and reproducibility in drug delivery performance, meeting regulatory standards and ensuring product efficacy.

5) Regulatory Compliance: Apurun's encapsulation efficiency analysis services align with regulatory requirements, facilitating compliance with pharmaceutical regulations. By adhering to standardized protocols and validation procedures, Apurun assists companies in meeting regulatory guidelines and obtaining product approvals.

Overall, Apurun's expertise in encapsulation efficiency analysis supports pharmaceutical companies in optimizing drug delivery systems, ensuring product quality, efficacy, and regulatory compliance.

pH (OPPTS 830.7000)

Test Method

Classification

Total Number of Tests

$140.00

pH determination, following the guidelines outlined in the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 830.7000 protocol, is crucial for lipid nanoparticles (LNPs) and liposomal drug products. Our services encompass precise pH measurements tailored to these formulations, ensuring compliance with regulatory standards. By employing standardized methodologies and calibrated equipment, we provide accurate pH assessments, essential for evaluating formulation stability, drug release kinetics, and potential interactions with biological systems. Our commitment to quality control and regulatory compliance enables pharmaceutical companies to meet stringent requirements and ensure the safety, efficacy, and regulatory compliance of their lipid-based drug delivery systems.

Gas Chromatography with the Flame Ionization Detector (GC-FID)

Test Method

Classification

Total Number of Tests

$940.00

Apurun's Services for GC-FID Analysis of Residual Solvents in LNPs and Liposomal Drug Products: 1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust GC-FID methods specifically tailored for residual solvent analysis in LNPs and liposomal drug products. These methods adhere to FDA guidelines, ensuring accuracy and reliability in assessing residual solvent levels. 2) Method Validation: Apurun conducts comprehensive validation studies to demonstrate the accuracy, precision, and robustness of the developed GC-FID methods for residual solvent analysis. This validation process ensures compliance with FDA requirements and instills confidence in the obtained results. 3) Testing Services: Apurun offers testing services utilizing validated GC-FID methods for residual solvent analysis in LNPs and liposomal formulations. These tests provide crucial information regarding the presence and levels of residual solvents, thereby contributing to quality control efforts and ensuring product safety. 4) Quality Control: Apurun's GC-FID testing services play a vital role in quality control by providing accurate assessments of residual solvent contents. Monitoring residual solvent levels helps ensure compliance with regulatory limits and standards, ultimately safeguarding product quality and patient safety. 5) Regulatory Compliance: Apurun's services are designed to align with FDA regulations, facilitating regulatory compliance for pharmaceutical products concerning residual solvent content. By adhering to standardized protocols and best practices, Apurun assists companies in meeting regulatory requirements and obtaining product approvals. Apurun's expertise in GC-FID-based residual solvent analysis supports pharmaceutical companies in ensuring the quality, safety, and regulatory compliance of LNPs and liposomal drug products.

Density (OPPTS 830.7300)

Test Method

Classification

Total Number of Tests

$540.00

Density characterization is an important aspect of quality control for lipid nanoparticles (LNPs) and liposomal drug products, and it's typically governed by established regulatory standards such as OPPTS 830.7300. Apurun's services for testing, method development, and validations can certainly support compliance with FDA guidelines in this regard. Here's how Apurun's offerings align with FDA guidelines for density characterization: 1) Methods Development: Apurun collaborates with pharmaceutical companies to develop robust methods for density characterization of LNPs and liposomal formulations. These methods are designed to accurately measure density under specified conditions outlined in regulatory standards such as OPPTS 830.7300. 2) Method Validation: Apurun validates the developed density measurement methods according to FDA guidelines for analytical method validation. This involves conducting validation studies to demonstrate the reliability, accuracy, precision, repeatability, and robustness of the methods for density characterization. 3) Testing Services: Apurun offers testing services using validated density measurement methods for LNPs and liposomal formulations. These tests are performed according to established protocols and standards, ensuring that the results are consistent, reliable, and compliant with FDA requirements for density characterization. 4) Quality Control: Apurun's testing services contribute to quality control efforts by providing accurate and comprehensive assessments of density characteristics. By monitoring density, Apurun helps pharmaceutical companies ensure the quality, consistency, and stability of their products throughout the manufacturing process and product lifecycle, as per FDA guidelines. 5) Regulatory Compliance: Apurun's methods development, validation, and testing services are designed to facilitate regulatory compliance with FDA guidelines for pharmaceutical products, including density characterization of LNPs and liposomal formulations. By adhering to established standards and best practices, Apurun ensures that the density measurements meet regulatory requirements and contribute to the safety and efficacy of these products. Apurun's comprehensive services for density characterization align with FDA guidelines for quality controls of LNPs and liposomal drug products. By providing accurate, reliable, and compliant density measurements, Apurun supports pharmaceutical companies in meeting regulatory requirements and ensuring the quality and safety of their products.

Viscosity (OPPTS 830.7100)

Test Method

Classification

Total Number of Tests

$900.00

Apurun provides testing, method development, and validation services for viscosity measurements aimed at nanoparticle characterization to support quality control of lipid nanoparticles (LNPs) and liposomal drug products, adhering to FDA guidelines. These services ensure that pharmaceutical formulations meet regulatory requirements for quality, stability, and efficacy. Viscosity measurements are crucial for assessing the physical properties and quality control of lipid nanoparticles (LNPs) and liposomal drug products. While there may not be specific FDA guidelines solely dedicated to viscosity measurements for LNPs and liposomal formulations, the FDA does emphasize the importance of comprehensive characterization and quality control of pharmaceutical products, including those utilizing nanotechnology. Here's how viscosity measurement can be applied in accordance with general FDA guidelines for LNPs and liposomal drug products: 1) Characterization of Formulation Consistency:Viscosity measurements can provide valuable insights into the consistency and rheological behavior of LNPs and liposomal formulations. Consistency in viscosity across batches is essential for ensuring uniformity and reproducibility in manufacturing processes, as well as for predicting product behavior during administration and storage. 2) Quality Control during Manufacturing: Viscosity measurements can be integrated into quality control protocols to monitor and control manufacturing processes. By establishing viscosity specifications and routinely measuring viscosity during production, manufacturers can identify deviations from established norms and implement corrective actions to maintain product quality. 3) Optimization of Drug Delivery Properties: Viscosity plays a crucial role in determining the flow behavior and stability of LNPs and liposomal drug products. By optimizing viscosity, formulation scientists can enhance drug delivery properties such as injectability, dispersibility, and residence time at the target site. Viscosity measurements contribute to the formulation optimization process by guiding the selection of excipients and manufacturing parameters. 4) Evaluation of Stability and Shelf Life: Changes in viscosity over time can indicate physical instability, degradation, or phase separation in LNPs and liposomal formulations. Stability studies incorporating viscosity measurements help assess the shelf life and storage conditions of pharmaceutical products, enabling manufacturers to establish expiration dates and storage recommendations. 5) Regulatory Compliance: While there may not be specific FDA guidelines mandating viscosity measurements for LNPs and liposomal drug products, comprehensive characterization and quality control are fundamental principles outlined in FDA regulations. Viscosity measurements, when conducted in accordance with validated methods and documented as part of product specifications, contribute to compliance with regulatory requirements for product safety, efficacy, and consistency. For LNPs and liposomal drug products, viscosity measurement is an important aspect of comprehensive characterization and quality control in accordance with FDA regulations. By integrating viscosity measurements into quality control protocols, manufacturers can ensure consistency, stability, and efficacy of LNPs and liposomal formulations, ultimately contributing to regulatory compliance and patient safety.

High-Performance Liquid Chromatography (HPLC)

Test Method

Classification

Total Number of Tests

$475.00

Apurun's services for testing, method development, and validations for High-Performance Liquid Chromatography (HPLC) purity and composition characterization align with FDA guidelines for quality controls of lipid nanoparticles (LNPs) and liposomal drug products. Here's how Apurun's offerings correspond to FDA guidelines: 1) Methods Development: Apurun collaborates with pharmaceutical companies to develop robust HPLC methods for the purity and composition characterization of LNPs and liposomal formulations. These methods are designed to accurately separate and quantify individual components such as lipids, drugs, and impurities, in accordance with FDA guidelines for analytical method development. 2) Method Validation: Apurun validates the developed HPLC methods following FDA guidelines for analytical method validation. This involves conducting validation studies to demonstrate the reliability, accuracy, precision, specificity, and robustness of the methods for their intended use in characterizing LNPs and liposomal drug products. 3) Testing Services: Apurun offers testing services using validated HPLC methods for purity and composition characterization of LNPs and liposomal formulations. These tests are performed according to established protocols and standards, ensuring that the results are consistent, reliable, and compliant with FDA requirements. 4) Quality Control: Apurun's testing services contribute to quality control efforts by providing accurate and comprehensive assessments of purity and composition characteristics using HPLC. By monitoring these critical parameters, Apurun helps pharmaceutical companies ensure the quality, consistency, and stability of their products throughout the manufacturing process and product lifecycle, as per FDA guidelines. 5) Regulatory Compliance: Apurun's methods development, validation, and testing services are designed to facilitate regulatory compliance with FDA guidelines for pharmaceutical products. By adhering to established standards and best practices, Apurun ensures that the HPLC-based purity and composition characterization of LNPs and liposomal formulations meet regulatory requirements and contribute to the safety and efficacy of these products. Apurun's comprehensive services for HPLC purity and composition characterization align with FDA guidelines for quality controls of LNPs and liposomal drug products. By providing accurate, reliable, and compliant analytical solutions, Apurun supports pharmaceutical companies in meeting regulatory requirements and ensuring the quality and safety of their products.

Liquid Chromatography Mass Spectroscopy (LCMS)

Test Method

Classification

Total Number of Tests

$820.00

Apurun provides comprehensive liquid chromatography mass spectrometry (LC-MS) services tailored specifically for the analysis of lipid nanoparticles (LNPs), liposomes, and other nanoparticle-based pharmaceuticals. These services encompass method development, validation, and testing to ensure accurate characterization of the composition, purity, and structural properties of these pharmaceutical formulations. By leveraging advanced LC-MS techniques, Apurun assists pharmaceutical companies in meeting regulatory requirements, ensuring product quality, and enhancing patient safety Apurun's Services for Liquid Chromatography Mass Spectrometry (LC-MS) for Nanoparticle Characterization: 1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust LC-MS methods for nanoparticle characterization in lipid nanoparticles (LNPs) and liposomal drug products. These methods are designed to accurately analyze the composition, purity, and structural properties of nanoparticles, ensuring compliance with FDA guidelines. 2) Method Validation: Apurun conducts comprehensive validation studies to demonstrate the accuracy, precision, and robustness of the developed LC-MS methods for nanoparticle characterization. Validation ensures reliability and compliance with regulatory standards, enhancing confidence in the obtained results. 3) Testing Services: Apurun offers testing services utilizing validated LC-MS methods for nanoparticle characterization in LNPs and liposomal formulations. These tests provide essential information about the composition and structural characteristics of nanoparticles, contributing to quality control efforts and ensuring product safety and efficacy. 4) Quality Control: Apurun's LC-MS testing services play a crucial role in quality control by providing accurate assessments of nanoparticle composition and structural properties. Monitoring these properties helps ensure product consistency, stability, and biocompatibility, meeting regulatory requirements and ensuring patient safety. 5) Regulatory Compliance: Apurun's services are aligned with FDA regulations, facilitating regulatory compliance for pharmaceutical products concerning nanoparticle characterization. By adhering to standardized protocols and best practices, Apurun assists companies in meeting regulatory requirements and obtaining product approvals. Apurun's expertise in Liquid Chromatography Mass Spectrometry (LC-MS) for nanoparticle characterization supports pharmaceutical companies in ensuring the quality, safety, and regulatory compliance of their LNPs and liposomal drug products, in accordance with FDA guidelines.

Differential Scanning Calorimetry (DSC)

Test Method

Classification

Total Number of Tests

$940.00

Apurun provides comprehensive liquid Differential Scanning Calorimetry (DSC) services tailored specifically for the analysis of lipid nanoparticles (LNPs), liposomes, and other nanoparticle-based pharmaceuticals. Leveraging advanced DSC techniques, Apurun assists pharmaceutical companies in characterizing the thermal properties, phase transitions, and stability of these formulations. This analytical approach ensures accurate assessment of critical parameters, contributing to product quality, efficacy, and regulatory compliance. Apurun's Services for Differential Scanning Calorimetry (DSC) for Nanoparticle Characterization: 1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust DSC methods for nanoparticle characterization in lipid nanoparticles (LNPs) and liposomal drug products. These methods are designed to accurately analyze thermal properties, phase transitions, and stability of nanoparticles, ensuring compliance with FDA guidelines. 2) Method Validation: Apurun conducts comprehensive validation studies to demonstrate the accuracy, precision, and robustness of the developed DSC methods for nanoparticle characterization. Validation ensures reliability and compliance with regulatory standards, enhancing confidence in the obtained results. 3) Testing Services: Apurun offers testing services utilizing validated DSC methods for nanoparticle characterization in LNPs and liposomal formulations. These tests provide essential information about the thermal behavior and stability of nanoparticles, contributing to quality control efforts and ensuring product safety and efficacy. 4) Quality Control: Apurun's DSC testing services play a crucial role in quality control by providing accurate assessments of nanoparticle thermal properties and stability. Monitoring these properties helps ensure product consistency, stability, and biocompatibility, meeting regulatory requirements and ensuring patient safety. 5) Regulatory Compliance: Apurun's services are aligned with FDA regulations, facilitating regulatory compliance for pharmaceutical products concerning nanoparticle characterization. By adhering to standardized protocols and best practices, Apurun assists companies in meeting regulatory requirements and obtaining product approvals. Apurun's expertise in Differential Scanning Calorimetry (DSC) for nanoparticle characterization supports pharmaceutical companies in ensuring the quality, safety, and regulatory compliance of their LNPs and liposomal drug products, in accordance with FDA guidelines.

Analytical testing and assays play a crucial role in characterizing and evaluating liposomes, lipid nanoparticles (LNPs), and nanoparticle drug products. Here are some common analytical techniques used in this context:

1. Particle size and distribution analysis: Techniques such as dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA) are employed to determine the size distribution of liposomes and LNPs. These methods provide information about the average particle size, polydispersity index, and size range of the nanoparticles.

2. Zeta potential measurement: Zeta potential is the electrokinetic potential at the particle surface and is an indicator of the stability of liposomes and LNPs. Laser Doppler electrophoresis or electrophoretic light scattering methods are used to measure zeta potential, which helps assess the colloidal stability of the nanoparticles.

3. Encapsulation efficiency: This assay determines the amount of drug or cargo encapsulated within the liposomes or LNPs. Various techniques, including centrifugation, ultrafiltration, or dialysis, followed by quantification of the free drug in the supernatant or filtrate, are used to calculate the encapsulation efficiency.

4. Drug release studies: These studies assess the release kinetics of the drug from liposomes or LNPs. Different release methods can be employed, such as dialysis, membrane diffusion, or dissolution testing, to mimic the conditions in which the nanoparticles will be administered.

5. Stability testing: Stability studies are conducted to assess the physical and chemical stability of liposomes and LNPs over time. This includes evaluating particle size, zeta potential, drug encapsulation, and integrity of the lipid bilayer under various storage conditions, such as temperature, humidity, and light exposure.

6. Morphological characterization: Techniques like transmission electron microscopy (TEM) or scanning electron microscopy (SEM) provide high-resolution imaging of liposomes and LNPs, allowing assessment of their size, shape, and structural integrity.

7. Drug content determination: This assay quantifies the amount of drug present in the liposomes or LNPs. Techniques such as high-performance liquid chromatography (HPLC), UV-Vis spectroscopy, or mass spectrometry (MS) are commonly used for drug content analysis.

8. In vitro release and uptake studies: These studies evaluate the release of drugs from liposomes or LNPs in simulated physiological conditions and their uptake by target cells. Various cell-based assays, including flow cytometry or fluorescence microscopy, can be employed to measure drug release and cellular uptake.

9. Toxicity assessment: Liposomes, LNPs, and nanoparticle drug products need to undergo toxicity evaluation. Assays such as cell viability assays (MTT, XTT), cell membrane integrity assays (LDH release), or in vivo toxicity studies are conducted to assess the safety profile of the nanoparticles.

It is important to note that the selection of specific analytical tests and assays may vary depending on the specific formulation, intended application, and regulatory requirements.