Vendor Voice in this preprint from our September 2011 issue, authors from Lamdagen describe a new label-free sensor platform for bioprocess development, monitoring, and validation during therapeutic antibody manufacture. The technology, referred to as localized surface plasmon resonance (LSPR), is made possible through the creation and use of nanostructured metallic films. The two areas most likely to benefit from this new technology are process development and monitoring and Quality Control. More effective process development efforts can lower costs of therapeutic…

Example Documents Many companies use risk assessments, yet their test protocols remain bloated and cumbersome, with a focus on protocol adherence rather than verification of system functionality. In the September 2011 issue, Peter Watler introduces the ASTM E 2500-07 international industry consensus standard for conducting risk-based design and qualification of GMP manufacturing systems.It uses risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design-qualification-operation lifecycle.This moves the process from a rigid, protocol-enforced accumulation of documentation…