Process Analytical Technology– tag –
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Drastic Cost Reduction in Biosimilar Manufacturing: Integrated Strategies of Continuous Bioprocessing, QbD, Single-Use Systems, and AI
Pharma Advancement USA Overview Integrated strategies including continuous bioprocessing with high-density cell culture, Quality by Design (QbD) with Process Analytical Technology (PAT), single-use systems with modular facility design, a... -
Single-Use Mixing Solutions in Bioprocessing: Optimizing Processes with Digital Twins and AI
Industry Insight (Facebook repost) Unknown Overview The selection of single-use mixing solutions in bioprocess engineering is crucial for process optimization, driven by the integration of advanced technologies like digital twins, AI, ma... -
MDPI Paper Proposes AI-Driven Digital Twin Framework for Real-Time Optimization of Industrial Fermentation
MDPI Switzerland Overview A new paper published in MDPI focuses on leveraging digital twins as an advanced AI application for industrial fermentation processes. The digital twin functions as a real-time virtual replica of a bioreactor, e... -
Bioseon Unveils Proof-Driven Operating Guides for Autonomous Biologics Manufacturing, Supporting CDMOs and Biopharma with Live Titer & CQA Control via Soft Sensors and Digital Twins
Bioseon Unknown Overview Bioseon has released 'Proof-Driven Operating Guides' for autonomous biologics manufacturing. These guides focus on live titer and critical quality attribute (CQA) control utilizing soft sensors, Process Analytica... -
Biopharmaceutical CDMO Capacity Crunch Persists, Driving Rapid Expansion in Cell and Gene Therapy Production
Contract Pharma USA Overview The biopharmaceutical industry continues to face a CDMO capacity crunch, prompting contract development and manufacturing organizations to heavily invest in expanding production capabilities, particularly for... -
Chemically Defined Media and Automation Key to Overcoming Raw Material Variability in Autologous Cell Therapy Manufacturing
BioProcess International USA Overview Addressing raw material variability in autologous adoptive cell therapies necessitates the adoption of chemically defined media, standardized handling, automation, and well-characterized unit operati... -
Real-Time Bioreactor Monitoring Advances with Raman Spectroscopy, Enhancing Cell Culture Precision and Efficiency
Spectroscopy Online USA Overview Process Raman Spectroscopy, utilizing fiber-optic probes, enables real-time, in-line chemical monitoring in bioreactors, tracking reaction conversion and cell-culture metabolite concentrations without sam... -
FDA Introduces Flexible CMC Guidance for Cell and Gene Therapy Products, Ending ‘Rule of Three’ for Commercial Validation Batches
BioProcess International USA Overview The FDA published and immediately implemented Level 2 guidance, 'CMC Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application' on May 5, 2026. This la... -
A4BEE Demonstrates Adaptive Digital Twin for Bioprocess Autonomy and Computer Vision for Non-Invasive Foam Management in Bioreactor Control
A4BEE Unknown Overview A4BEE has presented proof-of-concept for an adaptive digital twin aimed at bioprocess autonomy and computer vision for non-invasive foam management in bioreactor control. These innovations seek to bridge the gap be... -
Sartorius Accelerates Cell & Gene Therapy Commercialization with Comprehensive End-to-End Solutions
Sartorius Germany Overview Sartorius emphasizes its mission to accelerate the commercialization of cell and gene therapies (CGT) by providing end-to-end solutions that deliver reproducible performance and scalability. Its portfolio suppo...
