BioPharm International-10-15-2020

Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA’s acceleration program.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

For planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.