BioPharm International, June 2023

Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.

New fields are being explored to bring novel antibody candidates to the pipeline.

Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.

Scaling cell therapy production workflows requires the establishment of closed, automated steps.

Analytical characterization of biosimilars plays a crucial role in a successful path to regulatory approval.

Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.

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

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

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

Media developers and vector manufacturers face a combination of challenges and opportunities.

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.

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