The Link Between Manufacturing and Commercialization in Gene and Cell Therapies
The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
Now that the first cell and gene therapies have become commercial realities and more companies are involved in precision medicine research, different manufacturing platforms are being developed. However, as the authors write, developers need to consider the fundamental differences between these therapies and more traditional biopharmaceuticals to develop the right commercialization strategies.
Read this article in Pharmaceutical Technology’s Biologics and Sterile Drug Manufacturing 2019 eBook.
Article Details
Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 30–35
Citation
When referring to this article, please cite it as W. Colasante, P. Diesel, and L. Gerlovin, “The Link Between Manufacturing and Commercialization in Gene and Cell Therapies," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
