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 ...

The manufacture of biological products is a complex process that involves continual refinement throughout product development, post-approval and marketing. Reasons to alter the manufacturing process ...

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 ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...

The success or failure of the development of a biopharmaceutical product is governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, ...

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guidance is just now addressing the challenges of manufacturing cell and gene therapy (CGT) products with a proposed draft guidance, Manufacturing Changes and ...

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 ...

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 ...

Achieving equity is the purpose of the Elementary and Secondary Education Act of 1965, one of the legislative hallmarks of President Lyndon Johnson’s War on Poverty. Title I of the Act now provides ...