PTL’s NanoSight LM10-HSB Instrument is cGMP Compliant

Particle Technology Labs is pleased to announce that our NanoSight LM10-HSB instrument is cGMP compliant as of June 4, 2013 and is thereby the first cGMP NanoSight unit in the United States. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). NanoSight’s Nanoparticle Tracking Analysis technology, NTA, has been adopted for both research-based projects and as a quality control tool for regulated industries. With cGMP compliance established, NTA via PTL is now fully available to the pharmaceutical industry.

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.”

Says Jeremy Warren, CEO of NanoSight, “We are delighted that PTL has achieved cGMP accreditation for their NTA instrumentation; this is a first. While many would see this accreditation as a necessary burden to working within the Pharmaceutical Industry, PTL has embraced the discipline of methodology, training and record keeping to drive robustness in the results they get. In protein aggregation studies, samples naturally exhibit variations in aggregation kinetics and in end-points; standardizing the method allows users to minimize, quantify and factor out the instrument issues and concentrate on this inherent complexity.”