Author Archives: Maribeth Donovan Janke

Partnering with Innovators: From Raw Materials to Commercial-Ready Processes

Advancements in life sciences technologies and the increasing demands for improved, effective, and innovative products to prevent, treat, and in some cases, cure diseases have focused the attention of drug developers on new modalities such as mRNA-, DNA-, viral vector-, and cell-based therapies and vaccines. Novel biopharmaceutical products bring a level of complexity to developing and bringing them through design, clinical studies, and to the market. Like traditional drug products, complex therapies require robust, scalable manufacturing processes, a reliable quality-driven…

Bridging the Gap from Process Development to CGMP Manufacturing for Gene Therapies

Gene therapy holds the promise of treating the unmet needs of patients who suffer from rare genetic diseases. An estimated 4,000 medical conditions are a result of gene disorders with no established targeted treatments. Gene therapy offers new options away from the conventional symptomatic approach to disease treatment as well as provides hope for real cures. At Catalent Cell & Gene Therapy, we understand the unique and complex nature of bringing a gene therapy to market, and we are dedicated…