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System addresses the pharmaceutical industry’s need for compliant, semi-automated testing of nanoparticle drug formulations.

Agilent Technologies Inc. has 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.

"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."

Lifesaving drugs are increasingly being developed using nanoparticles for targeted drug delivery. These new dosage forms offer the promise of advancing patient care and treatment outcomes—particularly for oncology and cardiology patients—by reducing side-effects and improving drug solubility and bioavailability. However, nanoparticles can be incredibly difficult to work with from a dissolution testing perspective. This testing is a critical regulatory requirement for the development, manufacturing, and QC of medical drug dosage forms.

“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. 

Learn more about NanoDis

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. Now in its 20th year as an independent company delivering insight and innovation toward improving the quality of life, Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenue of $5.16 billion in fiscal 2019 and employs 16,300 people worldwide.

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