A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...

Dynamic AI systems applied in biopharmaceutical manufacturing must be governed within established regulatory frameworks.

Earlier this week, contract development and manufacturing organization (CDMO) Cellares announced its partnership with ...

Protein production in insect cells or in whole insects could move past the trade-off long associated with conventional ...

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 ...

A harmonized control strategy can ensure that polysorbate degradation does not lower biologic quality or efficacy.

Bavaria's BioM supports 548 biotech firms through incubators, mentorship, and bootcamps, helping startups like Tubulis grow ...

A pilot study from WuXi Biologics suggests existing fed-batch facilities could achieve an eightfold improvement in downstream ...

This study evaluates Batch Bayesian Optimization as a robust alternative using Sporosarcina pasteurii to optimize microbial ...

Industry benchmarking reveals that AI in biopharma has yet to move beyond administrative efficiencies, despite ambitions of ...

BPI Contributor Sidharth Ananthanarayan ...