The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...
A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...
Earlier this week, contract development and manufacturing organization (CDMO) Cellares announced its partnership with ...
BioProcess International learned about how advanced therapy developers and manufacturers are adapting to changing ...
Biopharmaceutical organizations are seeking out ways to increase predictability in clonal material generated during cell line ...
Bavaria's BioM supports 548 biotech firms through incubators, mentorship, and bootcamps, helping startups like Tubulis grow ...
Industry benchmarking reveals that AI in biopharma has yet to move beyond administrative efficiencies, despite ambitions of ...
Dynamic AI systems applied in biopharmaceutical manufacturing must be governed within established regulatory frameworks.
This study evaluates Batch Bayesian Optimization as a robust alternative using Sporosarcina pasteurii to optimize microbial ...
This poster proposes a novel strategy for minimizing impurity carry-over into downstream steps by adding trehalose during ...
Oceo Rover technology results highlighting its scalability and versatility in supporting a wide array of formulations and ...
Protein production in insect cells or in whole insects could move past the trade-off long associated with conventional ...
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