The Role of BioPhorum Extractables Data in the Effective Adoption of Single-Use Systems

Single-use systems (SUS) 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 BioPhorum (formerly BPOG) protocol. Readily available extractables data helps manufacturers using single-use technology to accelerate product qualifications, risk assessments, and process optimization.​

In this whitepaper, you'll find:​

  • An overview of the single-use systems landscape
  • Guidance for evaluating SUS for extractables and leachables (E&L)
  • Strategy for E&L validation
  • Case study: A risk-based approach to E&L assessment of final sterilization, single-use assembly


Field will not be visible to web visitor

Copyright 2020 Industry Dive Privacy Policy | Terms of Use