BioPharm International, July 2021 Issue

Understanding the process and product goals is just the first step to a holistic approach to process development.

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Help prevent contamination in a facility by zone.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

New challenges in extractable and leachable studies for cell and gene therapy products.

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Vaccines define the path to putting pandemic restrictions and pain in the rear-view mirror.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.