Agilent Molecular Spectroscopy Solutions For the pharmaceutical and biopharmaceutical industries

Importance of the Topic

High-performance molecular spectroscopy techniques play a central role in modern pharmaceutical and biopharmaceutical laboratories. They enable rapid, non-destructive analysis of chemical structures, concentration measurements, and quality assessment at every stage of the drug lifecycle, from initial discovery through manufacturing. By integrating multiple spectroscopic modalities, labs can improve data reliability, reduce bottlenecks, and maintain compliance with global regulatory standards.

Objectives and Overview

This document presents an integrated workflow for applying ultraviolet-visible (UV-Vis), fluorescence, infrared (FTIR), transmission Raman (TRS), and spatially offset Raman (SORS) spectroscopy across drug discovery, development, and manufacturing. It highlights Agilent’s modular instrument designs, accessory options, and compliance support features that streamline sample throughput, minimize preparation time, and support cGMP environments.

Methodology and Instrumentation

Agilent’s molecular spectroscopy portfolio includes:

• UV-Vis Spectrophotometers (Cary 60, Cary 3500) with fiber-optic probes, low-volume cuvette support, and multicell temperature control
• Fluorescence Spectrometer (Cary Eclipse) supporting fluorescence, phosphorescence, chemiluminescence, and time-resolved assays
• Fourier Transform Infrared Spectrometer (Cary 630) with interchangeable ATR, DialPath, and transmission modules
• Transmission Raman System (TRS100) for rapid content uniformity, assay, and identification of intact oral solid dosage forms
• Spatially Offset Raman (RapID, Vaya) for non-invasive raw material ID through opaque packaging

All instruments adhere to ISO 9001 manufacturing standards and offer software tools compatible with FDA 21 CFR Part 11/EMA Annex 11 for secure electronic records and signatures.

Main Results and Discussion

• Cary 60 delivers high-throughput UV-Vis data with sub-second kinetics and low-volume analysis without cuvettes.
• Cary 3500’s multicell, no-moving-parts design reduces alignment errors and permits parallel temperature-controlled measurements.
• Cary 630 FTIR supports rapid identification and quantification of APIs, excipients, and packaging materials with minimal sample prep.
• TRS100 cuts wet-chemistry bottlenecks by quantifying drug content and polymorphs in intact tablets within 15 minutes per batch.
• RapID/Vaya handheld SORS devices allow real-time raw material verification through multilayer packaging, reducing quarantine time and exposure risks.

Benefits and Practical Applications

• Rapid decision making in lead compound screening, reaction monitoring, and ligand binding assays
• Streamlined QA/QC workflows for content uniformity, assay, dissolution, and impurity analysis
• Non-destructive testing of final products, raw materials, and packaging with minimal operator intervention
• Enhanced compliance via integrated software suites supporting audit trails, user management, and electronic signatures
• Modular accessories that adapt a single spectrometer for diverse R&D and manufacturing tasks

Future Trends and Opportunities

• Integration of artificial intelligence and machine learning for spectral data interpretation and anomaly detection
• Greater automation and remote operation to support continuous manufacturing and real-time release testing
• Miniaturization of spectrometers for inline process monitoring and field-deployable quality control
• Expansion of spectral libraries and chemometric models for complex biological matrices and advanced polymorph screening

Conclusion

Agilent’s comprehensive molecular spectroscopy solutions address critical analytical needs in pharmaceutical and biopharmaceutical workflows. By combining robust instrument design, flexible accessories, and regulatory compliance, laboratories can accelerate R&D timelines, enhance manufacturing throughput, and maintain high standards of product quality and safety.

References

1. Agilent Technologies. Agilent Molecular Spectroscopy Solutions for the Pharmaceutical and Biopharmaceutical Industries. March 2022.