Dr Kevin Robinson recently caught up with Na Hye-jung, Head of Global Regulatory Affairs at Samsung Biologics, to pose the question: how do you solve the process optimisation equation of speed-to-market and cost efficiencies while maintaining a safe environment for both operators and end users?
If a sterile process is robust, it’s intrinsically balanced and meets the combined objectives of being optimised, cost-efficient, safe and compliant. Ultimately, the cost control and speed-to-market equilibrium needed by pharmaceutical developers depends on two things.
One, the manufacturer’s ability to comply with sterile current good manufacturing practice (cGMP) processes and, two, an appropriate regulatory strategy to accommodate agency expectations and facilitate approval.
As a cornerstone of their commercial activities, drug developers and their manufacturing partners must carefully consider how sterility assurance will be achieved throughout the manufacturing process chain.
Breaches in sterility will not only place the entire batch at risk … but could also jeopardise both patient and operator safety.
To ensure product safety and sterility, all the required controls must be in place from the drug substance (DS) manufacturing stage to when the drug product’s (DP) primary packaging is sealed at fill-finish.
Stringent process and environmental control technologies, as well as monitoring, are imperative to ensure regulatory compliance.
When registering a drug for production, manufacturers also have to demonstrate in chemistry, manufacturing and control (CMC) filings that the validated process is robust and ensures consistent product quality.
Suitable guidance is available in an International Society of Pharmaceutical Engineers (ISPE) white paper, which defines process robustness as “the ability of a manufacturing process to tolerate the expected variability of raw materials, operating conditions, process equipment, environmental conditions and human factors.”