BioPharm International, August 2022 Issue

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

The growth in demand of viral-vector-based gene therapies drives continuous efforts to improve viral vector manufacturing.

Automation enables intensification of downstream processes.

Successful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.

Manufacturers are taking the first steps toward process intensification.

A strong digital backbone is foundational in driving innovation.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

How can we fix the quality manufacturing issues that come with product shortages?