The Process Development Blog

CFD modelling of bioreactor mixing environments enables vaccine scale-up with two-thirds fewer experiments, eliminating stepwise progression between vessel sizes.

Discover the industry drivers for Continuous Processing and how it accelerates development and benefits your manufacturing strategy.

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

ATR-FTIR chemometric model provides real-time PAT feedback control for a flow acylation process, predicting species abundance within 3 area% of offline analysis.

In-situ IR tracking and engineering first-principles analysis reduced primary impurity in a -70°C lithiation process by over 40%, eliminating a 25% batch failure rate.

Inline Raman spectroscopy was used to map polymorph formation mechanisms in an API crystallisation step, eliminating batch failures and enabling successful scale-up to validation.

Ternary phase diagrams and PAT kinetic profiling raised enantiomeric excess from 92% to over 99% and yield from 87% to 98% for an oncology Phase I programme.

Thermal cycling controls API crystal morphology and size distribution, converting needles or plates into robust polycrystalline particles that filter and flow more easily.