Manufacturing Cell Therapies Development Strategies for Commercial Vision

whitePaper | March 16, 2023

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

whitePaper | August 5, 2022

The field of gene and cell therapy is experiencing a renaissance, with innovations in the use of viral vectors as a gene delivery vehicle being a key factor in the field’s growth.

whitePaper | January 16, 2022

All gene therapies insert engineered DNA/RNA into living cells to make or modify new proteins

whitePaper | May 27, 2023

The Human Genome Project was a monumental effort over more than a decade to determine the human DNA sequence and analyze genetic variation among individuals. The hope was that, armed with this understanding, phenotypic differences would be explainable by genetic variation, and health benefits could follow.

whitePaper | November 24, 2022

Smallpox was the first infectious disease for which an effective vaccine was developed. In the late 1700s, British doctor Edward Jenner devised a method to inoculate people with cowpox pus to give them immunity against smallpox, a much more deadly disease.

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section