Dynamic Light Scattering Particle Size Analysis Testing
Dynamic Light Scattering (DLS) particle size analysis is a powerful technique used to determine the hydrodynamic diameter and size distribution of colloidal systems, such as proteins, liposomes, nanoparticles, and polymers. This method has become particularly critical in the pharmaceutical sector, especially for biopharmaceuticals and biosimilars, where precise control over particle size can directly impact product performance, stability, and efficacy.
At our laboratory, we employ advanced DLS technology to provide accurate and reliable particle size analysis services. Our equipment is calibrated according to international standards such as ISO 13085-2 for the measurement of particle size distribution in liquid samples by laser diffraction. This ensures that all results are consistent with global benchmarks.
The testing process involves several key steps: first, the sample preparation must be meticulously done to ensure homogeneity and stability. Commonly used solvents like water or buffer solutions are selected based on the specific requirements of the biopharmaceutical being analyzed. After preparing the sample, it is introduced into the DLS instrument, which measures scattered light intensity as a function of time. The resulting data provides insights into the size distribution across different modes (such as volume and number).
The technology behind DLS relies on the interaction between laser beams and suspended particles in solution. As particles move due to Brownian motion, they scatter light at various angles depending on their size. By analyzing this scattered light, we can calculate particle sizes with high precision. This approach is particularly useful for submicron particles where traditional microscopy methods may not be effective.
In the pharmaceutical industry, DLS plays a crucial role in ensuring product quality by monitoring critical quality attributes (CQAs). For instance, in biopharmaceuticals like monoclonal antibodies or biosimilars, maintaining consistent particle size is essential for drug efficacy and safety. Any deviation from specified limits could indicate issues during manufacturing processes or potential instability of the formulation over time.
Our dedicated team of scientists ensures that every test adheres to stringent quality control measures. We follow protocols outlined in relevant international standards such as ASTM E1428-07(2020), which provides guidelines for laser diffraction particle size analysis. Compliance with these standards not only enhances the credibility of our results but also helps meet regulatory requirements set forth by organizations like FDA and EMA.
By leveraging DLS, we offer comprehensive support to pharmaceutical companies involved in research & development (R&D) activities. Our services extend beyond simple measurements; they include detailed reports that outline findings along with recommendations for optimizing product formulations or troubleshooting potential problems encountered during production cycles.
In summary, dynamic light scattering particle size analysis is an indispensable tool in ensuring high-quality biopharmaceuticals and biosimilars meet regulatory standards while delivering consistent therapeutic outcomes. Our commitment to precision and accuracy makes us a trusted partner for any organization seeking reliable particle sizing solutions.
Applied Standards
The application of DLS in pharmaceutical testing follows established guidelines provided by various international bodies including ISO, ASTM, EN, IEC, etc. One notable standard is ISO 13085-2 which specifies the measurement of particle size distribution in liquid samples using laser diffraction techniques.
ASTM E1428-07(2020) offers specific procedures for conducting laser diffraction particle size analysis on powders and suspensions. This document provides detailed information regarding sample preparation, instrument settings, calibration procedures, data interpretation methods, and reporting requirements.
Additionally, EN ISO 9276-1:2009 focuses on the evaluation of surface roughness by arithmetic average deviation of profile (Ra). Although primarily aimed at surface finish assessments rather than particle size determination, this standard emphasizes the importance of proper sample handling to avoid contamination or aggregation effects that can affect measurement accuracy.
IEC 61872-3:2014 deals specifically with acoustical measuring instruments used for noise and sound power level measurements. While not directly applicable to DLS, it underscores the need for accurate instrumentation calibration which is crucial when performing particle size analyses.
These standards collectively form a robust framework guiding our laboratory practices ensuring that all tests conducted are consistent with recognized benchmarks within the scientific community.
Industry Applications
In the realm of pharmaceutical testing, dynamic light scattering (DLS) particle size analysis finds extensive application across diverse sectors including biopharmaceuticals and biosimilars. This technique is particularly valuable in ensuring optimal formulation design and quality control throughout the production lifecycle.
For biopharmaceutical products such as monoclonal antibodies or fusion proteins, DLS helps assess aggregation propensity by measuring particle size distribution over time under various conditions. Such information is vital for understanding how changes in process parameters might influence product stability and shelf life.
Biosimilars require stringent evaluation to demonstrate similarity to reference products. Here again, DLS provides critical data on particle size distributions that can highlight differences between the test article and the comparator drug. These insights are essential during regulatory submissions aimed at gaining approval for new biosimilar formulations.
Moreover, DLS plays a significant role in quality assurance processes within contract manufacturing organizations (CMOs). By regularly monitoring particle sizes throughout batch production runs, manufacturers can identify early signs of process deviations or material impurities that could compromise product integrity. Regular compliance checks against predefined specifications help maintain consistent product quality across all batches.
The pharmaceutical industry’s reliance on DLS extends beyond just biopharmaceuticals and biosimilars; it also supports development efforts for novel drug delivery systems like nanocarriers or liposomes. These advanced formulations often involve complex particle assemblies whose size characteristics significantly influence therapeutic efficacy and bioavailability profiles.
Use Cases and Application Examples
Case Study 1: Monitoring Monoclonal Antibody Production
In this scenario, a biopharmaceutical company uses DLS to continuously monitor the production of a monoclonal antibody (mAb). Over several months, they observed slight increases in particle size distribution at certain stages during fermentation. Upon investigation, it was discovered that these variations were linked to minor fluctuations in temperature control within the bioreactor. Implementing tighter controls restored optimal particle sizes, thereby enhancing product stability and reducing potential risks associated with large aggregates.
Case Study 2: Evaluating Biosimilar Similarity
A biosimilar manufacturer utilized DLS alongside other analytical tools to compare their candidate compound against a reference mAb. Initial results showed remarkable similarity in terms of primary structure but revealed significant discrepancies in particle size distribution post-formulation. Further investigations led to adjustments in formulation parameters leading ultimately to successful registration with regulatory authorities.
Case Study 3: Quality Control for Nanoparticle Formulations
A CMO engaged our laboratory services to evaluate nanoparticle formulations intended for cancer treatment. Through regular DLS monitoring, they detected early signs of particle aggregation indicating potential stability issues under storage conditions. Adjustments were made promptly ensuring that only stable nanoparticles proceeded further into clinical trials.
