By Madeleine Giaquinto, JD, and Kalah Auchincloss, JD, MPH
The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.
In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them.
Some of pharma’s top legacy brands developed their own innovative response to the demand for strategic outsourcing, emerging in a distinct class of contract development and manufacturing services suppliers immersed in Big Pharma.
To investigate the chemical challenges that can be overcome by the right choice of the linker, we have explored the influence of a variety of polyethylene glycol (PEG) linkers on the structure of a model cysteine-bioconjugate.