• Harnessing in-line Near-Infrared (NIR) and offline Transmission Raman Spectroscopy for real-time quality attribute analysis
• Exploring applications in assessing key attributes such as assay and crystallinity with enhanced efficiency.
• Comparing rapid spectroscopy methods to traditional techniques like HPLC and XRPD: Time-saving advantages and precision.
• Case studies on integrating spectroscopy tools into pharmaceutical workflows for improved productivity.

With the demand to bring products faster to market, R&D organizations are challenged to accelerate product development. One way to increase speed in analytical development is utilising faster methods to generate the required data more quickly. Vibrational spectroscopy methods like Raman and near-infrared spectroscopy have the potential to decrease analysis time by orders of magnitude.

Based on spatially off-set Raman scattering Transmission Raman Spectroscopy (TRS) is a technology enabling the measurement of an entire tablet or powder sample in less than a minute, compared to 30-90 minutes for currently applied methods based on HPLC or XRD. Additionally, sample preparation is omitted or reduced significantly compared to those technologies. The TRS instrument is equipped with an automated sampling stage allowing for a measurement of up to 96 samples in a single run. As TRS is non-destructive, samples can be used for additional analysis after measurement.

In this work, we present the application of TRS for the determination of assay and API crystallinity in the drug product development of an AbbVie internal compound. Validated test methods for assay and limit tests for API crystallinity have been developed. Analytical personnel were trained, and the method applied successfully to primary batches. With over 1100 project samples measured by TRS, approximately 30 weeks of hands-on-fame could be saved in the analytical team compared to conventional HPLC methods.

Frank Theil

Senior Scientist II Global Technical Centers

AbbVie