Pharmaceutical Technology, June 2023

What factors do CDMOs consider vital to their success?

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

The future is set to be a running theme for this year’s CPHI event, which will take place in-person at the Fira Barcelona Gran Via in Spain between 24–26 October 2023.

What implications will EMA’s recent regulatory reform have on pharma?

Despite being a relatively small nation, Switzerland is booming for biotech innovation.

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

Nanotech-based delivery technologies are receiving significant attention.

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

An increase in applications for gene therapies is putting stress on FDA’s resources.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.

Vaccine nationalism strengthens viruses and poses deadly risks for all involved.

Third-party contract packaging service providers can help save time and money.

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

The ROSS Model HSM-405SC-25 Inline High Shear Mixer with solids/liquid injection manifold (SLIM) Technology is designed for production floors that require flexibility.

The Agilent 8697 Headspace Sampler -XL Tray features improvements to capacity and ease-of-use.

PSG Biotech’s BioProTT FlowSU System is a next-generation flow-measurement system intended for single-use biopharma applications.

Catalent’s ProteoSuite Oral platform is designed for optimized selection of orally developable targeted protein degrader candidates.