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.

Synergic kinetic and physiological control to improve the efficiency of Komagataella phaffii recombinant protein production bioprocesses.

The yeast Komagataella phaffii (Pichia pastoris) is currently considered a versatile and highly efficient host for recombinant protein production (RPP). Interestingly, the regulated application of specific stress factors as part of bioprocess engineering strategies has proven potential for increasing the production of recombinant products. This study aims to evaluate the impact of controlled oxygen-limiting conditions on the performance of K.

CPV of the Future: AI-Powered Continued Process Verification for Bioreactor Processes.

According to the standard guidelines by the FDA, process validation in biopharma manufacturing encompasses a life cycle consisting of three stages: process design (PD), process qualification (PQ), and continued process verification (CPV). The validity and efficiency of the analytics methods employed during the CPV require extensive knowledge of the process. However, for new processes and new drugs, such knowledge is often not available from Process performance qualification and Validation (PPQV).

Innovative Bioprocess Strategies Combining Physiological Control and Strain Engineering of to Improve Recombinant Protein Production.

The combination of strain and bioprocess engineering strategies should be considered to obtain the highest levels of recombinant protein production (RPP) while assuring product quality and process reproducibility of heterologous products. In this work, two complementary approaches were investigated to improve bioprocess efficiency based on the yeast . Firstly, the performance of two lipase 1 producer clones with different gene dosage under the regulation of the constitutive were compared in chemostat cultures with different oxygen-limiting conditions.

Source of fungus contamination of hydrophilic soft contact lenses.

Fungus infiltration within hydrophilic lenses has been a rare finding. This case report confirms previous findings that fungal contamination of hydrophilic contact lens is possible. The present report, to our knowledge, is the first demonstration of the association of fungus from contaminated cosmetics with hydrophilic contact lenses.