Cell and gene therapies are becoming more and more popular because of encouraging clinical results worldwide. Major pharma manufacturing companies have invested in the concept's commercialization worldwide. Recently, we read about Takeda’s license for commercialization of Aloficel (developed by TiGenix), Celgene’s acquisition of Juno Therapeutics or Gilead’s acquisition of Kite Pharma. As this sector grows further, there is hope that more and more complex therapies will enter the market leading to a consequent increase in the number of treated patient population. This will put further pressure on manufacturing and R&D leading to larger adoption of QbD (Quality by design) principles. The data volume will increase significantly and that is where the concept of big data analytics will kick in. Data is important- it guides the manufacturing operations; allows proper monitoring and control to ensure quality and assures efficiency, production quality, and regulatory complian...