Risk Management In Biologics Manufacturing: Strategies For Adaptive Biomanufacturing And Excellence In Single-Use Technologies

By Neel Gosaliya and Andrew Samy, AGC Biologics

For biomanufacturing, SUTs—pre-sterilized, disposable components—reduce cleaning demands, shorten turnaround times, and lower cross-contamination risks, making them ideal for multi-product and early-phase pipelines. Yet, SUTs introduce new challenges, including material compatibility, extractables and leachables (E&L), supply chain complexity, and limited scalability for very large batches.

To manage these risks, CDMOs like AGC Biologics implement tiered, phase-appropriate risk assessments at key milestones: before process characterization, prior to process qualification, and ahead of commercialization. This structured approach covers raw material traceability, E&L testing strategies, elemental impurity analysis, and shipping robustness using tools like Failure Mode and Effects Criticality Analysis. These measures help identify and mitigate risks proactively, streamline regulatory submissions, and maintain quality as processes scale.

Hybrid facilities that combine stainless steel and SUTs allow CDMOs to flexibly address diverse client needs, using stainless systems for high-volume commercial runs and SUTs for smaller, agile projects. Ultimately, successful SUT implementation depends on both robust risk management and experienced CDMO partnerships to ensure speed, reliability, and compliance across global manufacturing networks.