Digitalization of QbD Risk Assessments
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Review of SUT Adoption in Biopharma Manufacturing
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Subjectivity in Quality Risk Management
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Phase-appropriate Compliance for Cell and Gene Therapies
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
