Agilent Launches New NanoDis System for Nanoparticle Dissolution Testing
Agilent Technologies Inc. (NYSE: A) launched the NanoDis System for nanoparticle dissolution testing, designed to ensure compliance with 21 CFR Part 11 regulations. Developed in collaboration with MyBiotech GmbH, this system enhances the efficiency of R&D and manufacturing workflows by providing an automated process for consistent QC of new drug formulations. The NanoDis System is recognized as a finalist for the CPhI Pharma Awards, highlighting its innovative role in advancing pharmaceutical quality control.
- Launch of the NanoDis System enhances R&D and manufacturing workflows.
- System ensures compliance with critical regulations (21 CFR Part 11).
- Recognized as a finalist for the CPhI Pharma Awards, showcasing industry innovation.
- None.
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today 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.
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
