By Fern Slingsby and Katy McLaughlin
Cell Line Development: The Foundation of a Reliable Production Process
Biopharmaceutical drug products, or biologics, are fast becoming an essential branch of the healthcare industry. Primarily consisting of therapeutic recombinant proteins, biopharmaceuticals have had considerable success in treating various diseases, particularly cancers and inflammatory disorders. However, developing a reliable process for commercial biopharmaceutical production is logistically and technically demanding, with many opportunities for projects to break down.
Biopharmaceutical manufacturing employs living host cells as production centers. The development of a robust, high-yielding cell line is the foundation of a reliable production process. However, cells introduce a source of variability and a unique set of technical challenges.
Early awareness of the possible obstacles to efficient process development is critical for making informed project decisions. Here, we discuss the challenges associated with cell line development in the production of biologics before outlining solutions that can help biotech developers evade the pitfalls of misinformed decision-making.