PAT Solutions for the Pharma Industry

PAT for Small Molecule Drug Manufacturing

Bruker offers PAT solutions for small molecule manufacturing with FT-NIR and Raman Process Spectroscopy. These techniques give real-time, nondestructive insight into API concentration, blend uniformity, moisture and polymorphs directly in reactors, blenders and dryers. FT-NIR handles fast quantitative checks during blending and drying, while Raman adds molecular detail for reaction tracking and polymorph work. Both techniques fit GMP, FDA PAT and QbD frameworks, including 21 CFR Part 11. With reliable chemometric models, PAT reduces variability, speeds up batch release and strengthens continuous manufacturing.

NMR adds real-time, quantitative insight into critical quality attributes during small molecule development and manufacturing. In-line or at-line data clarifies reaction progression, confirms product identity and helps meet PAT guidelines. This leads to faster decisions, consistent process control and a stronger quality strategy.

NMR also tracks structural and compositional changes in formulations and identifies degradation pathways early. These measurements help optimise excipient interactions, confirm API integrity and document stability trends over shelf life. This creates a tighter link between development, scale-up and commercial manufacturing.

PAT for Bioprocess Monitoring

NMR combined with PAT delivers continuous feedback on metabolite profiles, reaction kinetics, and nutrient consumption in bioprocesses. This real-time visibility enables dynamic control of fermentation and cell culture conditions, improving yield, reducing variability, and supporting Quality by Design principles.

FT-NIR and Raman spectroscopy add complementary information for bioprocessing. They track key parameters such as glucose and lactate levels, biomass development, product formation, and critical media components directly in-line or at-line. With fast spectra and simple interfaces, they follow trends from early growth to harvest. Together, these optical methods help stabilise bioreactors, document consistency and keep processes within defined design spaces.

PAT for IVT mRNA reactions

NMR enables real-time monitoring of IVT reactions by quantifying nucleotide conversion and ATP consumption. This ensures accurate tracking of reaction progress, optimizes yield, and verifies mRNA integrity, supporting robust control and consistent quality in biologics manufacturing.