Optimizing End-To-End Contract Analytical Support For Cell And Gene Therapies

By Elena Dukhovlinova, Ph.D., Alcami

The development and production of cell and gene therapies (CGTs) presents unparalleled complexities within the modern pharmaceutical landscape. Robust control strategies and meticulous precision are paramount throughout the manufacturing and quality control (QC) processes. Established research technologies must be meticulously adapted to adhere to stringent Good Manufacturing Practices (GMP) regulations.

CGT innovators are accustomed to navigating a multitude of challenges – process-related, analytical, and supply chain hurdles – at every stage of the drug lifecycle. These novel therapeutic modalities push the boundaries of existing pharmaceutical practices, demanding a constant state of innovation, akin to "building a train and riding it at the same time." Unwavering perseverance, exceptional agility, and a deep well of scientific expertise are crucial for establishing and executing a rigorous quality strategy, ensuring the safety and efficacy of these groundbreaking drugs.

Learn how a contract manufacturing partner with robust end-to-end services — including analytical support; method development, qualification, and validation; cold and cryogenic storage; and fill-finish capabilities — can help you overcome challenges at every step of the drug lifecycle.