Mechanochemistry Can Reduce Life Cycle Environmental Impacts of Manufacturing Active Pharmaceutical Ingredients
Contributor(s):: Galant, O, Cerfeda, GMcCalmont, AS, James, SL, Porcheddu, A, Delogu, F, Crawford, DE, Colacino, E, Spatari, S
The scale-up of mechanochemical methods could play a transformative role in making manufacturing processes in the pharmaceutical industry greener by eliminating solvent use and recovery. Combined with energy-efficient continuous processing that consolidates reaction steps, mechanochemistry's...
Accelerating biologics manufacturing by modeling or: Is Approval under the QbD and PAT approaches demanded by authorities acceptable without a digital-twin?
Contributor(s):: Zobel-Roos, Steffen, Schmidt, Axel Mestmäcker, Fabian Mouellef, Mourad, Huter, Maximilian, Uhlenbrock, Lukas, Kornecki, Martin, Lohmann, Lara, Ditz, Reinhard, Strube, Jochen
Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a...