A scale-down and CFD modelling approach delivered a 10% crystallisation yield improvement within existing regulatory filing parameters in 12 weeks.

For the synthesis & crystallization of APIs, Mixed Suspension Mixed Product Removal Crystallizers (MSMPRCs) can help address common issues in batch production.

Resin screening using 96-well plates and robocolumns eliminated a 50% yield loss in mAb polishing chromatography and defined a commercially viable purification step.

A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns

Four essential elements for an ATMP development plan: risk assessment, scaled-up process control, CMC decision records, and early manufacturing integration.

In this case study, scientists determine drying conditions that preserve the API physicochemical properties, while minimizing the drying time.

Learn how a good numerical modeling strategy can help scale-up of single-use bioreactors.

Computational solvent screening narrows 70 candidates to under 10 in 2–3 days, with solubility predictions within 20% of experiment—applied to API crystal morphology design.

Combining laser light scattering and microscopy for pharmaceutical particle size analysis eliminates common measurement artefacts and provides verifiable, morphology-aware results.

Subtle changes in particle size, shape, & distribution can have a major impact on pharma solubility and stability and cause flow and formulation issues.