NMR & EPR Pharma Solutions

NMR and EPR are invaluable tools enabling access to detailed structural, quantitative and dynamic insights, supporting the characterization and understanding of molecules, materials, interactions and complex chemical or biological process. These are indispensable to R&D highly demanding sectors such as in the Biopharmaceutical and Biotech industry. These techniques are routinely applied in research and development laboratories considering their unique ability to deliver comprehensive molecular and behavioral information, contributing significantly to accelerate the drug discovery and development process. Considering the dramatic increase of the complexity of the therapeutic product landscape over the last 30 years, going from small molecules drugs to complex biologics to Cell & Gene therapies, leveraging the capabilities of NMR and EPR means not just advancing scientific understanding but also gaining a strategic edge in new drug product research and development throughput, as well as in their manufacturing efficiency.

The discovery of small molecule drugs, driven by efficient structure-activity relationship (SAR) studies, and rapid advancements in biologics and new drug modalities, are at the forefront of modern pharmaceutical innovation. The increasing complexity of biologics, such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bispecific antibodies, as well as therapeutic peptides and oligonucleotides (collectively known as TIDES), has significantly heightened the analytical requirements for characterizing these molecules. Comprehensive or partial NMR characterization and monitoring of their higher order structure (HOS) by NMR fingerprinting are crucial. These processes ensure efficacy, safety, and regulatory compliance, providing a robust framework for the development and production of novel drugs.

NMR has recently become a key technique in Process Chemistry and Bioproduction for deep understanding, monitoring and optimization. By integrating flow accessories like InsightMR and Fourier RxnLab, NMR allows for customizable process monitoring designed to user needs. These advanced technologies provide real-time monitoring and analysis, enabling scientists to make important decisions, troubleshoot, and adjust production parameters for better yields and quality. Additionally, these innovations facilitate the efficient scaling of bioprocesses from lab to production, ensuring consistency and high quality in larger batches. The Fourier PAT system further enhances process analytics with in-depth spectral analysis, ensuring seamless data integration and accuracy. Together, these advancements improve existing production methods and drive innovative solutions for the pharmaceutical and biotech industries.

NMR is pivotal in modern pharmaceutical quality control, offering absolute, non-destructive, and inherently quantitative analyses. Its unique combination of versatility and robustness supports a wide range of applications, from routine raw material identification to precise quantitative assays of finished drug products. With minimal sample preparation and no need for identical reference standards, NMR enables platform procedures with simplified risk-assessment and life-cycle management, maximizing efficiency with true build-in quality. The Fourier 80 benchtop NMR delivers these benefits in a compact, cryogen-free and easy-to-use design, seamlessly integrating into laboratories and manufacturing environments. Fully automated and supportive of GMP/GLP compliance, the Fourier 80 offers a cost-effective solution to leverage the full potential of NMR for modern and compliant QC practices.

Our hassle-free, all-in-one solutions for GMP and GLP compliance include ready-to-use protocols for installation and operational qualification, certified samples, and integrated workflows for system suitability tests. Bruker GxP kits simplify compliance and streamline documentation for easy integration of NMR into regulated environments. They provide a comprehensive solution to ensure seamless system life-cycle management, from design qualification to routine performance verification.

Data integrity and compliance with 21 CFR Part 11 and Annex 11 of EU-GMP are ensured by our state-of-the-art, easy-to-use software solution, enabling streamlined and efficient operations while meeting stringent regulations. With support for high customization and automated workflows, our solutions adapt to each setting, bringing all the benefits of NMR technology to your laboratory.

A critical aspect of pharmaceutical development is to ensure the stability of the drug prior to be delivered to the patient, so its efficiency is guaranteed and its potential toxicity limited. This is often achieved by developing the active pharmaceutical ingredient and finished product in solid form. The same active substance can often be existing in different crystal forms, referred to as polymorphs or even be amorphous. While being the same chemical substance, each polymorph could have different stability, bioavailability and pharmaceutical applications. Solid state NMR is here a unique tool able to identify polymorphic forms to ensure product efficiency and assess possible patent infringement. Furthermore, by applying TD-NMR methodology, one can achieve rapid characterization of solid formulations by accurately assessing physical and chemical properties, ensuring consistency and quality. Along this line, contactless check NMR weighing systems can support the quality control process by allowing precise, non-invasive weight measurements. These advanced NMR methodologies collectively enhance our ability to develop and quality control solid formulations ensuring regulatory compliance, efficiency and safety.