Method Validation

Perfect Your Formulations Using Cryo-TEM.

Develop a scalable formulation for your drug product and solidify your analytical test methods by harnessing NIS GMP expertise. Partner with our team and leverage:

Decades of scientific experience working with complex formulations, lipid-based solutions, as well as recent advances such as LNPs.
State-of-the-art cryo-TEM microscopes.
A smooth transition from preclinical development to process scale up, clinical batch and cGMP manufacturing.

Cryo-TEM is being used more frequently in drug development and biopharmaceutical research. NIS is a fully compliant testing lab operating to current Good Manufacturing Practices (cGMP), using cutting edge microscopes and internally developed AI for reproducible automated reporting. We ensure quality by establishing procedures and validated methodologies for your specific drug product, allowing you to demonstrate consistency across the drug product lifecycle.

How can you benefit from GMP compliant nanoparticle characterization services?

Batch-to-batch Reproducibility, including Scale Up: GMP cryo-TEM 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: GMP cryo-TEM can demonstrate comparability between generic and brand-name drugs. It can also show process changes, scale up and site equivalency for the newer LNP modalities. At NIS we can analyze critical quality attributes like particle size and morphology, to demonstrate that you can ensure consistency across formulations. ‍
Stability: GMP 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, helping to identify any changes or degradation that may occur. By monitoring these parameters, manufacturers can optimize formulation stability, ensuring that gene and drug delivery systems maintain their integrity and efficacy throughout their shelf life.

Utilizing GMP Cryo-TEM Imaging and Analysis for Gene Delivery Solutions.

Cryo-TEM imaging and analysis provides essential insights into the morphology, encapsulation and payload distribution, and uniformity of gene delivery nanoparticles, such as adeno-associated virus (AAV) and lipid nanoparticles (LNPs). By characterizing these key attributes, cryo-TEM studies facilitate the optimization of gene delivery systems, ultimately enhancing their efficiency and effectiveness in therapeutic solutions.

cryo-tem method validation services for gmp regulatory filings | lipid nanoparticle method validation — Representative cryo-TEM image of lipid nanoparticles (left), showing a frequency histogram for particle area equivalent diameter (AED) metric distributions for the sample using a 10 nm size bin (center) and Max Feret Diameter metric distributions for the sample, showing probability distribution function (PDF) on top and cumulative probability distribution (CDF) on bottom (right).

cryo-tem method validation services for gmp regulatory filings | aav adeno-associated virus method validation — *Example cryo-TEM image of Adeno-associated Virus (AAV) (left) with automated payload distribution analysis of full, partially full, and empty capsid ratios (right).*

Utilizing GMP Cryo-TEM Imaging and Analysis for Drug Delivery Solutions.

Cryo-TEM imaging and analysis offers valuable insights into the structural characteristics of drug delivery systems, including particle size, morphology & lamellarity, and encapsulation efficiency. By providing detailed visualization and quantitative data, cryo-TEM enables researchers to optimize drug delivery formulations, leading to improved efficacy and targeted delivery in therapeutic solutions.

cryo-tem method validation services for gmp regulatory filings | liposome method validation — *Example cryo-TEM image of liposomal drug delivery formulation (left) with lamellarity analysis data (right).*

Submit Filings Confidently with our cGMP Compliant Nanoparticle Characterization & Method Validation.

NIS is the first and only GMP-compliant cryo-TEM lab in North America, committed to top-tier imaging while upholding GMP regulations.

‍Our Quality Unit ensures compliance with 21 CFR 210-211, implementing robust cryo-TEM nanoparticle characterization processes, including imaging and qualitative Services such as fraction counting and size distribution determination. As a GMP-compliant facility, NIS maintains the highest standards in sample preparation, imaging, and data analysis. We offer comprehensive cryo-TEM imaging and analysis solutions for biopharmaceutical development and manufacturing, empowering confident decision-making in drug development.