Single-use systems streamline CGT manufacturing by reducing cleaning validation and enabling quick changeovers, essential for ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

The success of the mRNA vaccines for COVID-19 led to explosive growth in lipid nanoparticle (LNP)-mediated drug delivery for RNA vaccines and therapeutics. As these projects scale into clinical trials ...

Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...