BioPharm International, July August 2024

Automation technologies used in the development and manufacture of biopharmaceuticals continue to evolve, providing the potential for reduced costs and time.

Optimizing AAV vector manufacturing will be necessary to meet anticipated future market demand.

AAV and lentivirus both have pros and cons in their use for specific gene therapy applications.

The biopharma industry is seeking ways to apply cell and gene therapies to mass patient populations.

The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.

Gamma irradiation is being supplemented with alternative technologies.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

Will Sanofi’s plan to recruit the younger generation through its participation in the upcoming 2024 Olympic and Paralympic Games, being held in Paris, pay off?

The implementation of new quality control methods must be reported to regulators, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.