A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.
Identifying the many factors that factor in when trying to obtain the perfect blend for your powder formulation.
There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?
Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.
Investigating the source of this consumption increase early on and correcting the problem will improve the performance and uptime of all automated plant equipment.
“How long should a set of tools last?” is one of the most common questions asked of tooling vendors. The answer is dependent on many factors.
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?
Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.
Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.
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