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 ...
Dynamic AI systems applied in biopharmaceutical manufacturing must be governed within established regulatory frameworks.
BioProcess International learned about how advanced therapy developers and manufacturers are adapting to changing ...
Biopharma companies must weigh the operational complexity of continuous bioprocess against its potential productivity gains.
A harmonized control strategy can ensure that polysorbate degradation does not lower biologic quality or efficacy.
BPI Contributor Sidharth Ananthanarayan ...
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 ...
Protein production in insect cells or in whole insects could move past the trade-off long associated with conventional ...
This study evaluates Batch Bayesian Optimization as a robust alternative using Sporosarcina pasteurii to optimize microbial ...
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