Highly potent active pharmaceutical ingredients (HPAPIs) represent an increasing fraction of new compounds in pharmaceutical pipelines today. Flexible and phase-appropriate infrastructure is needed to bring the next innovative medicines based on these challenging compounds from concept to commercialization. Thispresentation describes Lonza's HPAPI "manufacturing 4.0" investments and the company's innovative capabilities.
C-level executives must take an early and active role in vetting potential partners using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.
Future evolutions in the biosimilar regulatory pathway will require biosimilar manufacturers to ask several critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.
The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.