Pharmaceutical quality and manufacturing teams will face two significant challenges in the coming year: drug shortages and rising new types of complex therapies, such as precision medicines.
Recently, the U.S. FDA Task Force on Drug Shortages shed light on the impact quality has on drug supply. It found that nearly two-thirds of 163 drugs that went into shortage between 2013 and 2017 were a result of supply disruptions associated with manufacturing or quality problems (1).
To the second point, complex therapies are typically produced in smaller volumes and their delicate requirements for care create difficulties along the supply chain. Traditional drug manufacturing processes are not suited for these highly individualized medicines.