Agilent Technologies has introduced the new NanoDis System to address the pharma industry’s need for compliant, semi-automated testing of nanoparticle drug formulations.
The system combines Agilent instrumentation and software, helping customers to meet 21 CFR Part 11 and other regulations through its application.
NanoDis System for nanoparticle dissolution testing also provides a dedicated workflow that is automatable and auditable.
NanoDis System, designed alongside nanoparticle manufacturer MyBiotech’s Dr Emre Türeli, aids R&D formulation chemists in bringing new formulations into manufacturing faster.
It also helps manufacturing teams to deliver consistent batches of QC-passed new drug products ready for commercial sale in an automated and compliant manner.
Agilent Technologies Liquid Phase Separation division global marketing associate vice-president Michael Frank said: “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).
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“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.”
Though many lifesaving drugs are currently in development using nanoparticles for targeted drug delivery, from a dissolution testing perspective, nanoparticles are complex to work with.
These kinds of dosage forms help to improve patient care, as well as treatment outcomes especially in oncology and cardiology patients, as they lower side-effects and better drug solubility and bioavailability.
Nanoparticle testing is a critical regulatory need for developing, manufacturing and QC of medical drug dosage forms.