The biopharmaceutical industry is often credited as being one of the most innovative of all sectors. And while scientists in R&D are charged with finding new treatments and perhaps even cures for a wide variety of diseases with unmet medical needs, it is the engineers and their efforts in manufacturing that often make the difference in biopharma being able to deliver to patients. But the manufacturing process is becoming more challenging as we continue to move toward personalized medicines. For example, in 2017 Novartis received the first-ever FDA approval for a CAR-T cell therapy treatment — Kymriah (pronounced kim-rye-ah) for the treatment of patients up to age 25 with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Yet less than one year later, the company announced having some variability in the manufacture of the product.