Overcoming Challenges in HPAPI Analysis with Miniaturization

Rapid Insights

Highly potent active pharmaceutical ingredients (HPAPIs) play a pivotal role in modern drug development, especially in oncology, inflammatory diseases, and antiviral therapeutics where their therapeutic effects at exceptionally low doses bring significant advantages. However, the potency of HPAPIs introduces a challenge for their safe handling, demanding stringent controls through containment and robust safety measures to protect laboratory personnel and ensure compliance with regulatory standards.

Due to the demand for high sample quantities of traditional analytical technologies, involving open or semi-open setups and processes prone to making particles airborne, the risk of exposure in significant. Laboratories handling HPAPIs are thus required to invest in custom-built facilities with stringent safety and containment measures. While essential, these measures come with substantial added cost and often prolonged timelines for project execution.

Another way to increase handling safety in the laboratory is to reduce the material quantities being handled and the duration of sample preparation and transfer operations, thus containing the maximum daily exposure levels. The Solubility Company’s proprietary Single Particle Analysis (SPA®) platform addresses these challenges through groundbreaking miniaturization, speed, and advanced containment features. With the ability to perform comprehensive solubility and dissolution analyses using just 20-30 µg of material, SPA® drastically minimizes the quantity of potent material required for extensive high-quality testing.

Operating within a fully enclosed, HEPA/ULPA-filtered environment, with minimal handling steps and durations, the SPA® platform ensures safe and efficient analysis capabilities up OEB5 (OEL band category 3b, <0.1 µg/m3) compounds, an ideal solution for the pharmaceutical industry’s most demanding applications – talk to our experts.

 

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