An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
Single-use systems are increasingly popular in biomanufacturing. For patient safety, biomanufacturers must systematically assess and mitigate risks posed by extractables and leachables (E&L) in these systems. In the absence of official E&L guidance, manufacturers are fulfilling regulatory expectations by following the BPOG protocol. Readily available extractables data helps manufacturers using single-use technology to accelerate product qualifications, risk assessments and process optimisation.
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