Introduction
The client is one of the leading drug manufacturers in the world. Their expertise lies in delivering innovative products in synthetic chemistry, medical chemistry, process development, scale-up chemistry, and analytical and manufacturing domains. It provides high-quality, integrated services in DMPK, toxicology and formulation.
Challenges
The need of the hour for the client was an accurate Particle Size Analysis solution for an innovator’s sample. The Particle Size Distribution (PSD) through Laser Diffraction Technology was proving to be a disaster. The sample preparation was extremely cumbersome and the new drug development timeline was rapidly approaching. Hence, the client was not sure whether microscopy would work.
Incessantly, the pressure mounted from the client’s US partners who were demanding quick & accurate results in lesser time frames.
Solutions
ImageProVision implemented the Particle Size Analyser (ipvPSA) to address this critical challenge. IPV worked in close collaboration with the clients to completely revamp the methodology for particle identification which eliminated all barriers concerning PSD in a short span of 3 months.
The innovative implementation of the ipvPSA with added features swiftly helped the client to isolate the particles and separate agglomerations. Additionally, new particle identification algorithms were developed.
Also, manual options were provided for user-specific inputs and customized reports were developed in accordance with the client's expectations. Statistics like distribution patterns based on Circular Equivalent Diameter (CED), and surface areas were also developed by IPV experts.
Benefits
→ Drug development project successfully completed within the agreed timelines
→ Massive savings on development time led to a drastic reduction in costs for R&D
→ New drug sample could be analyzed with great ease and lesser time
→ Bespoke customization of reports and additional statistics enabled informed decision-making and improved processes by focused corrections
→ One-on-one training with the client’s researchers and analysts helped them build new skills and learn new things in no time
→ Instant online support and frequent on-site visits ensured a smooth execution and negligible downtime.