Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.
This case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.
Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
Preparation is key for remote vendor and contract partner audits.
The COVID-19 pandemic generated partnerships among organizations with the goal of changing the way in which assay development and tech transfer of these assays are conducted moving forward.