Genezen is proud to announce that members of our scientific team are contributing authors to the newly released Springer Nature title, Approved: The Life Cycle of Drug Development— a comprehensive resource that covers the revolutionized innovations of biotherapeutics in the multi-dimensional nature of drug development.
As a CDMO exclusively focused on gene and cell therapy, Genezen brings deep technical knowledge and real-world experience to the chapters authored by our experts. This guide delves into the multi-faceted process of drug development, covering critical areas such as pharmacology, biomarkers, toxicology, product development, manufacturing, and clinical trials—all framed within the stringent requirements set by the FDA. Readers will find in-depth discussions on the latest technologies, statistical approaches, and quality assurance measures. This resource offers a timely and thorough exploration of the complexities and innovations shaping this critical space, and provides essential guidance to navigating today’s complex regulatory landscape.
We’re proud to share that several members of the Genezen team are contributing authors to this important publication, underscoring our commitment to advancing viral vector manufacturing through both hands-on expertise and thought leadership.
In Chapter 4, “Cellular Therapies: From a Theoretical Concept to an Immuno-augmented Reality,” Pratima Cherukuri, Aalia N. Khan, Karan Gera, Atharva Karulkar, Sweety Asija, Ankit Banik & Rahul Purwar present a complete overview of the historical development of cellular therapies and their progress over the years.
In Chapter 5, “Hope Unlocked: Gene Therapy with Viral Vectors and Gene Editing,” authors Jennifer J. Thiaville, Mariana Santana Dias, Sayuri E. M. Kato, Shashwati Basak, Srinivas Rengarajan, Hilda Petrs Silva, Natasha Rivas & Susan M. D’Costa focus on the most common viral vectors used in gene therapy, their biology, clinical applications, and production strategies, highlighting approved platforms, adverse events, and regulatory impacts. In addition, they provide review on the most recent gene editing tools and their application on gene therapy, discussing the analytics required to ensure that the viral vector platforms can be validated and approved for the clinic, their challenges, and future outlooks.
This publication reflects the collective expertise driving the field forward and reinforces Genezen’s position as a trusted, science-driven CDMO partner.
We congratulate all the contributors and encourage anyone involved in advanced drug development — from R&D through commercialization — to explore this valuable reference.
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