Cell culture engineering

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Since the introduction of recombinant human growth hormone and insulin, protein therapeutics have significantly expanded healthcare options. Many patients with previously untreatable life-threatening diseases now benefit from these drugs. Initially, the first generation of protein therapeutics was produced in recombinant Escherichia coli, but the focus has shifted to mammalian cells due to their ability to perform complex post-translational modifications efficiently. The 1990s saw a rapid growth in mammalian-cell-derived therapeutics, particularly antibodies, which have since surpassed E. coli products in market value. A notable aspect of recent antibody therapies is the larger doses required for effective treatment, leading to increased demand for these drugs. This rising need has not only prompted the construction of new manufacturing plants but has also significantly enhanced the productivity of cell culture processes, which has improved by an order of magnitude over the past decade. The combination of these advancements has rapidly expanded the availability of protein therapeutics for clinical applications, addressing the growing needs of patients worldwide.