Forbes contributors publish independent expert analyses and insights. I am the Kester and Brynes Professor at Columbia Business School and a Chazen Senior Scholar at the Jerome A. Chazen Institute for ...

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...

We're bringing back this column from May 2008 because it makes points that many still misunderstand. Specifically, assertions that one set of global standards would bring greater "comparability" ...

DSC provides quantitative and reproducible data, making it an important assay in HOS and comparability analysis for product evaluation during development (including site-to-site and batch-to-batch ...

Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of ...

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

We’re not sure if we’re having another epiphany, or merely looking at the world a little bit differently, but we have some thoughts on an area of accounting practice and theory that we’d like to share ...

“Keep your eyes on your own paper” may not be the most effective directive when it comes to reaching ESG goals. New research shows that companies that compare financial data against their peers tend ...

The Paris Agreement delegates the establishment of national climate goals to individual governments through the NDCs 12. As a result of the absence of a commonly agreed burden-sharing scheme within ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. To assess ...

Food & Drug Administration (FDA) guidance is just now addressing the challenges of manufacturing cell and gene therapy (CGT) products with a proposed draft guidance, Manufacturing Changes and ...

Typical sites for measurement of core temperature include the pulmonary artery and midesophagus, however, these sites are available in a small minority of patients. In lieu of a direct measurement of ...