Method Validation

NIS is the first and only GMP-compliant cryo-TEM lab in North America, dedicated to delivering top-tier imaging while adhering to rigorous GMP regulations.

Our Method Qualification and Validation studies ensure that the images and quantitative data generated from cryo-TEM or negative stain TEM analysis meet the highest quality standards, providing thorough documentation, traceability, and adherence to regulatory guidelines.

Phase appropriate, method validated characterization supports you in demonstrating:

• Batch-to-batch Reproducibility, including Scale Up: Ensures consistent quality in gene and drug delivery by enabling precise batch-to-batch comparisons. Robust imaging & analysis studies verify uniformity of critical quality attributes, including particle size, morphology, cargo loading, and more, across different batches in order to prove reproducibility. ‍
• Comparability: Demonstrate comparability between generics or biosimilars and brand-name drugs. Cryo-TEM and NS TEM can demonstrate critical quality attributes, like particle size and morphology, to show consistency across formulations, including newer LNP modalities. ‍
• Stability Studies: Cryo-TEM is a key tool in determining the stability of final drug formulations. Visualizing critical attributes such as particle size, morphology, and distribution, provides insight into the physical characteristics of formulations over time and under different storage conditions (time, pH, buffer, and more), helping to identify any changes or degradation that may occur. Monitoring these parameters can help optimize formulation stability, ensuring that final formulations maintain their integrity and efficacy throughout their shelf life.