Recommendations for Artificial Intelligence Application in Continued Process Verification.

This review paper explores the transformative impact of Artificial Intelligence (AI) on Continued Process Verification (CPV) in the biopharmaceutical industry. Originating from the CPV of the Future project, the study investigates the challenges and opportunities associated with integrating AI into CPV, focusing on real-time data analysis and proactive process adjustments. The paper highlights the importance of aligning AI solutions with regulatory standards and offers a set of comprehensive recommendations to bridge the gap between AI's potential and its practical, compliant, and safe application in pharmaceutical manufacturing.

Influence of Running Surface Using Advanced Footwear Technology Spikes on Middle- and Long-Distance Running Performance Measures.

This study evaluated the effects of advanced footwear technology (AFT) spikes on running performance measures, spatiotemporal variables, and perceptive parameters on different surfaces (track and grass). Twenty-seven male trained runners were recruited for this study. In Experiment 1, participants performed 12 × 200 m at a self-perceived 3000 m running pace with a recovery of 5 min.

Continuous Process Verification 4.0 application in upstream: adaptiveness implementation managed by AI in the hypoxic bioprocess of the cell factory.

The experimental approach developed in this research demonstrated how the cloud, the Internet of Things (IoT), edge computing, and Artificial Intelligence (AI), considered key technologies in Industry 4.0, provide the expected horizon for adaptive vision in Continued Process Verification (CPV), the final stage of Process Validation (PV). producing lipase 1 under the regulation of the constitutive promoter was selected as an experimental bioprocess.

Scalable protein production by Komagataella phaffii enabled by ARS plasmids and carbon source-based selection.

Background: Most recombinant Komagataella phaffii (Pichia pastoris) strains for protein production are generated by genomic integration of expression cassettes. The clonal variability in gene copy numbers, integration loci and consequently product titers limit the aptitude for high throughput applications in drug discovery, enzyme engineering or most comparative analyses of genetic elements such as promoters or secretion signals. Circular episomal plasmids with an autonomously replicating sequence (ARS), an alternative which would alleviate some of these limitations, are inherently unstable in K.