Industry experts at Cell Summit 2026 say the public lacks understanding of biologics and growing distrust poses challenges ...
A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...
Biopharmaceutical organizations are seeking out ways to increase predictability in clonal material generated during cell line ...
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 ...
BPI Contributor Sidharth Ananthanarayan ...
The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...
BPI Contributor Jeisa Pelet ...
In its Q4 earnings call to investors on February 25, vaccine developer Vaxcyte expressed optimism about its VAX-31 invasive pneumococcal disease (IPD) vaccine program and discussed the company’s ...
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 ...
Figure 1A: Antibody–drug conjugate (ADC) structure and delivery pathways; linker chemistry determines the mechanism by which cytotoxin release occurs. This schematic shows a monoclonal antibody (MAb) ...
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