PTL establishes cGMP compliance for Nanoparticle Tracking Analysis to serve the pharmaceutical industry
Image: PTL Director of Analytical Services, William Kopesky, uses the cGMP certified NanoSight LM10-HSB system for nanoparticle characterization.
Salisbury, UK, 4th June,2013: NanoSight announces that Particle Technology Labs, PTL, has established cGMP compliance for Nanoparticle Tracking Analysis, NTA, and this is now available on a contract basis to the pharmaceutical industry.
PTL is the leading particle characterization research and advisory company in the United States, providing assistance to a wide range of industries. Nanoparticle Tracking Analysis, NTA, has been adopted for both research-based projects and as a quality control tool for regulated industries. PTL’s NanoSight LM10-HSB instrument is certified cGMP as of June 4, 2013. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).
With cGMP compliance established, NTA via PTL is now fully available to the pharmaceutical industry. NTA technology will broaden PTL’s analytical capabilities by allowing quantification of particle concentrations in the submicron range. In addition, NTA provides an orthogonal or alternate technique to traditional dynamic light scattering (DLS), which until now was PTL’s only technique capable of submicron particle size determination. While suitable for many samples, as with any particle sizing technique, DLS does present some specific limitations. Traditional DLS instruments typically have relatively high particle concentration requirements—a minimum of 100 to 150 ppm. The LM10-HSB, being two to three times more sensitive than DLS, can analyze concentrations of particles as low as 50 ppm. In addition, as a technique with an intensity-weighted measurement, DLS distributions may be biased towards the upper end by just a few large particles. NTA overcomes these limitations through its individual particle-by-particle counting. Furthermore, PTL’s access to NTA as an orthogonal technique will enable the validation of a hypothesis or questionable finding provided by the results of the DLS instruments obtained in-house.
William Kopesky, PTL’s Director of Analytical Services, has driven the process to be the first US laboratory with a cGMP compliant NTA. “We are excited to have this new technology in our laboratory. As a cGMP qualified instrument, the NanoSight LM10-HSB expands our capabilities to our regulated clients, providing them with an accurate particle concentration and size device in the submicron range.”
Continuing, Kopesky added, “NTA has significantly better resolution than DLS, as we have verified here at PTL. Its ability to count particles in the submicron range constitutes a paradigm shift. Access to NTA technology is a benefit for several applications. One example is California Proposition 65, which requires companies to test their products and materials for the existence of nano-sized particles. Thanks to the sensitivity of NTA technology, PTL can now detect an even lower level of submicron particles.”
To find out about the company and to learn more about particle characterization using NanoSight’s unique Nanoparticle Tracking Analysis solutions, visit www.nanosight.com and register to receive the next issue of NanoTrail, the company’s electronic newsletter.
NanoSight delivers the world’s most versatile and proven multi-parameter nanoparticle analysis in a single instrument. NanoSight’s “Nanoparticle Tracking Analysis” (NTA) detects and visualizes populations of nanoparticles in liquids down to 10 nm, dependent on material, and measures the size of each particle from direct observations of diffusion. Additionally, NanoSight measures concentration and a fluorescence mode differentiates suitably-labelled particles within complex background suspensions. Zeta potential measurements are similarly particle-specific. It is this particle-by-particle methodology that takes NTA beyond traditional light scattering and other ensemble techniques in providing high-resolution particle size distributions and validates data with information-rich video files of the particles moving under Brownian motion.
This simultaneous multiparameter characterization matches the demands of complex biological systems, hence its wide application in development of drug delivery systems, of viral vaccines, and in nanotoxicology. This real-time data gives insight into the kinetics of protein aggregation and other time-dependent phenomena in a qualitative and quantitative manner. NanoSight has a growing role in biodiagnostics, being proven in detection and speciation of nanovesicles (exosomes) and microvesicles.
NanoSight has installed more than 600 systems worldwide with users including BASF, GlaxoSmithKline, Merck, Novartis, Pfizer, Proctor and Gamble, Roche and Unilever together with the most eminent universities and research institutes. NanoSight’s technology is validated by 800+ third party papers citing NanoSight results. NanoSight’s leadership position in nanoparticle characterization is consolidated further with publication of an ASTM International standard, ASTM E2834, which describes the NTA methodology for detection and analysis of nanoparticles. For more information, visit www.nanosight.com/.
PTL is the leading particle characterization research and advisory company in the United States. The company works with major organizations across the private, public and scientific research sectors. Their scope and expansive knowledge of particle technology allows PTL to address problems that no one else can, and provide insight and perspective necessary for clients to make the right decisions. PTL has deep functional expertise in industrial sectors such as pharmaceutical, environmental, petroleum-chemical, beauty and cosmetics, manufacturing, and food and beverage. The company is the recognized leader in particle characterizations, providing clients with a broad range of expert services in particle size and count distribution, surface area and image analysis, thermal analysis, powder flowability, and method development, verification, and validation. For more information, visit www.particletechlabs.com
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