Cell Line Development

The FDA approved the first DNA recombinant protein – human insulin (Humulin) – in 1982, setting the precedent for using recombinant technologies to generate therapeutics. Since then, there has been rapid growth in the number of biologics entering the market targeting a variety of therapeutic areas1. The blockbuster status of many biologics and advancements in biotechnology have driven the growth of this sector of drug development, with 55 biologics authorized in 2021 alone.

Monoclonal antibodies (mAbs) and their derivatives – including Fabs and Fc fusions – have shown remarkable market growth in the past few decades. The use of mAbs as therapeutic agents has become routine for the treatment of many diseases such as asthma, macular degeneration, arthritis, Crohn’s disease, and various
types of cancer.

As biopharmaceutical companies continue to recognize their potential, the global mAb market is expected to expand further. In 2020, the mAb market was valued at $146,642 million and has been predicted to grow at a compound annual growth rate (CAGR) of 10.2% to reach $390,582 million by 2030.

Meeting the increasing global demand for biotherapeutics is a significant challenge and relies on the ability to reproducibly deliver biologics at scale. The success of moving a biologic project from lab- to industrial-scale hinges on cell line development (CLD). CLD is the foundation of biotherapeutic development and manufacturing. By getting the processes right the balance of high quality, high yield and speed needed to successfully bring a Biologic to market can be achieved.