Adopting single-use systems (SUS) is an attractive solution for current challenges within the biopharmaceutical industry. However, before implementing single-use solutions, biomanufacturers must ensure that the required SUS product quality attributes are met. In this special report, subject-matter experts from Sartorius provide insights into SUS implementation strategies for biopharmaceutical manufacturing. Their discussion covers four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing extractables and leachables (E&L), and assuring system integrity and robustness. Then, the writers present a case study demonstrating how Sartorius Confidence validation services leveraged a risk-based approach to carry out safety assessment of leachables risk for a client’s SUS-based manufacturing process. The guidance given in this report is meant to help enable a data-driven, risk-based approach to implementing SUS for protection of drug quality and patient safety.
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