Agilent Technologies Inc. recently announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation and software to enable customers to meet 21 CFR Part 11 and other regulations through its application, the new NanoDis System delivers a dedicated workflow that is automatable and auditable.
Designed in collaboration with Dr Emre Türeli from nanoparticle manufacturer MyBiotech GmbH, the NanoDis System enables R&D formulation chemists to deliver new formulations into manufacturing faster, and also allows manufacturing teams to deliver consistent batches of QC-passed new drug products ready for commercial sale—all in an automated and compliant manner.
Nanodis in use
"Agilent's introduction of the NanoDis System is significant in that it is the first nanoparticle testing solution that allows methods to be easily transferred from R&D to QC, supporting scientists in meeting the requirements of United States Pharmacopeia (USP)," said Michael Frank, associate vice president of global marketing for Agilent’s Liquid Phase Separation division. "The NanoDis System can be universally implemented, therefore ensuring that our customers' global laboratory locations deliver the same results every time. Additionally, the NanoDis System is an end-to-end, single-vendor solution that is fully supported by a dedicated global team."
“The new NanoDis System gives us a far better insight and thorough understanding of dissolution of nanoparticles, enabling a truly efficient formulation development where we can rely on in-vitro data for the lead formulation selection,” commented Dr Emre Türeli, CSO MyBiotech GmbH.
The Agilent NanoDis System was selected as a finalist for the CPhI Pharma Awards for excellence in Pharma: Analysis, Testing and Quality Control. The awards celebrate the thinkers and creators at the forefront of driving the pharmaceutical industry forward through innovation, technology and strategies.
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