The Process Development Blog

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.

Harnessing the power of CFD to optimize process equipment cleaning protocols

When commercial impurity standards don't exist, custom synthesis unblocks QC. APC used protection-deprotection chemistry to achieve >99% purity at gram scale.

Five orthogonal protein aggregation analysis techniques explained—SEC, tryptophan fluorescence, aggregation index, NTA, and dye-binding assays—for biologic development teams.

CHO cells are pivotal for mAb production. The use of PAT e.g. Raman spectroscopy can help optimize processes, reducing time-to-market and costs.

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