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

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

BPI Contributor Sidharth Ananthanarayan ...

Biopharmaceutical organizations are seeking out ways to increase predictability in clonal material generated during cell line ...

BioProcess International learned about how advanced therapy developers and manufacturers are adapting to changing ...

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

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

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

Biopharma companies must weigh the operational complexity of continuous bioprocess against its potential productivity gains.

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

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

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