Safely accelerating drug development for brighter outcomes

Significance of the topic

Ensuring drug safety, efficacy and regulatory compliance across discovery, development, clinical trials and manufacturing requires integrated analytical capabilities. Spectroscopy, materials characterization, and controlled extrusion processes are central to characterizing APIs, excipients and final dosage forms, enabling process understanding, in-line monitoring (PAT), polymorph and amorphous content analysis, and reproducible scale-up. Robust software and service infrastructure that secure data integrity and support regulatory requirements (e.g., 21 CFR Part 11, USP/EP) are equally critical to translate laboratory findings into reliable commercial products.

Objectives and overview of the material

This whitepaper-style brochure presents Thermo Fisher Scientific’s portfolio of spectroscopy and materials characterization instrumentation, extrusion systems, software and services targeted to pharmaceutical workflows. It outlines capabilities across the pipeline — research/discovery, development, clinical studies and manufacturing — and highlights how analytical tools and validated software contribute to quality assurance, process control, and regulatory readiness. Practical considerations for scale-up and continuous processing are emphasized.

Used instrumentation

• X-ray photoelectron / X-ray plasmon spectroscopy (XPS)
• Energy-dispersive spectroscopy (EDS)
• Raman spectroscopy and Raman microscopy (including DXR2)
• Fourier-transform infrared spectroscopy (FTIR), Nicolet Summit FTIR
• Near-infrared spectroscopy (NIR)
• X-ray diffraction (XRD) — ARL EQUINOX series, SolstiX XRD Software
• Ultraviolet-visible spectroscopy (UV-Vis): Evolution 350, NanoDrop One micro UV-Vis
• IR microscopy
• NMR, LC-MS, mass spectrometry (MS), scanning probe microscopy (SPM), electron microscopy (EM)
• Rheometers and viscometers
• Twin‑screw extruders and granulators: Pharma mini HME, Pharma 11, Pharma 16, Pharma 24 (HME and TSG operation)
• OMNIC Paradigm, OMNIC Security Suite, SolstiX, ValPro package, and Thermo Scientific Security Suite for 21 CFR Part 11 compliance

Methodology and instrumentation integration

The portfolio is positioned to support each stage of drug development through complementary analytical methods and scalable extrusion technology. Key methodological themes include:

• Non‑destructive spectroscopic identification and compositional analysis (Raman, FTIR, UV‑Vis, NIR) for raw material screening, assay development and QC.
• Crystallinity and polymorph assessment (XRD, Raman) and amorphous content determination for formulation stability and bioavailability control.
• Hot‑melt extrusion (HME) and twin‑screw granulation (TSG) for solubility enhancement, consistent API dispersion and enabling continuous manufacturing.
• Rheological measurements and microscopy to characterize processability, crystallization behavior and to guide extrusion parameters.
• Inline/at‑line process analytical technology (NIR, Raman) for real‑time monitoring and control of continuous processes to reduce offline sampling and variability.
• Governance via validated software suites providing audit trails, centralized spectral databases, and 21 CFR Part 11 compatible security features to preserve data integrity throughout the lifecycle.

Main results and discussion (capabilities and evidence of performance)

Although this document is product-focused rather than data-centric, it demonstrates several practical outcomes:

• End‑to‑end analytical coverage enables consistent quality assurance from gram‑scale feasibility through multi‑kilogram pilot and commercial production using scaled extrusion platforms (Pharma mini → Pharma 11/16 → Pharma 24).
• Integrated PAT solutions with NIR and Raman support in‑process monitoring, reducing batch variability and accelerating time‑to‑release.
• XRD and Raman capabilities allow robust polymorph identification and quantification of amorphous fractions, essential for assessing stability and bioavailability risks.
• Validated instrument/software configurations (e.g., Evolution 350 UV‑Vis, ARL EQUINOX XRD, Nicolet Summit FTIR with Security Suite) simplify compliance with GMP, pharmacopoeia standards and 21 CFR Part 11.
• Extrusion platforms designed from pharma‑grade materials and modular downstream options (pelletizers, chill rolls, conveyors) enable reproducible product forms and straightforward scale‑up paths.

Benefits and practical applications

• Accelerated formulation screening using micro‑scale HME and high‑sensitivity spectroscopies reduces material consumption and identifies promising candidates earlier.
• Improved solubility and controlled release through HME and TSG process design for diverse dosage forms (tablets, implants, films).
• Reduced regulatory risk via validated software, audit trails and harmonized security across platforms, facilitating audit readiness and dossier preparation.
• Continuous manufacturing enablement through compatible extruders and inline analytics, driving productivity gains and lower variability.
• Comprehensive service and training offerings minimize downtime and support IQ/OQ/PQ qualification activities for regulated environments.

Future trends and opportunities

Key directions where these technologies converge to shape future pharmaceutical practice:

• Wider implementation of continuous manufacturing paired with robust PAT (NIR/Raman) to enable real‑time release testing and reduced time‑to‑market.
• Increased automation and data integration across instruments and LIMS, with stronger emphasis on secure, centralized spectral/databank management and ML‑assisted analytics for faster decision making.
• Miniaturized and high‑throughput HME and analytical workflows enabling rapid screening of complex formulations with limited API availability.
• Strengthened regulatory expectations for electronic records and data integrity, making validated software suites and auditability a commodity requirement.
• Expanding use of multimodal analytics (combining XRD, Raman, FTIR, microscopy and rheology) to better predict long‑term stability and in vivo performance from early studies.

Conclusion

Thermo Fisher Scientific’s combined offering of spectroscopic instruments, extrusion technology, validated software, and global service aims to provide pharmaceutical developers with a cohesive toolkit spanning discovery to manufacturing. The integrated approach targets reproducibility, regulatory compliance and scalable production while enabling PAT and continuous manufacturing strategies. For organizations seeking to accelerate development timelines and reduce technical and regulatory risk, aligning analytical selection, software validation and extrusion scale‑up is essential.

References

• Case study: Using FT‑NIR for pharmaceutical melt extrusion process monitoring
• Confocal Raman analysis of a transdermal nicotine patch by a DXR2 Raman Microscope
• Dynamic structural studies of pharmaceutical products using ARL EQUINOX Series X‑ray diffractometers
• Ensuring safer and effective pharmaceutical formulations by X‑ray diffraction
• Evaluating Active Ingredients in Pharmaceutical Hot Melt Extrusion Products with Raman Imaging
• FT‑Raman mapping of multicomponent solid dosage forms
• Guide to pharmaceutical standards for Thermo Scientific UV‑Vis Spectrophotometers
• Innovative rheological and extrusion solutions for drug development
• Thermo Scientific Pharma mini Implant Line: The complete solution for injectable drug delivery systems
• Validated systems for pharmaceutical environments (Evolution UV‑Vis spectrophotometers)
• XRD Investigation of Ibuprofen with ARL EQUINOX 100 in Transmission Mode