International Council for Harmonisation– tag –
-
Six Modeling Approaches, Including Digital Twins, Unlock Complex Bioprocess Data for Optimized Manufacturing
BioProcess Online USA Overview Six key modeling approaches, with a strong emphasis on digital twins, are presented for effectively leveraging complex bioprocess data. Digital twins provide a comprehensive virtual representation of physic... -
Digital Twins Revolutionize Bioprocessing: Predictive Models Boost Efficiency in Upstream, Downstream, and Fill-Finish Operations
BioProcess International USA Overview Equipment-level digital twin models are now practical in bioprocessing, enabling enhanced prediction and optimization across upstream, downstream, and fill-finish stages. These models integrate real-... -
Continuous Bioprocessing Delivers Significant Gains in Biopharmaceutical Manufacturing Efficiency and Cost Reduction, Driven by 500L Single-Use Perfusion Bioreactors
BioProcess International USA Overview Biopharmaceutical manufacturers are rapidly adopting continuous bioprocessing, integrating upstream cell culture and downstream operations to boost productivity, cut costs, and reduce facility footpr... -
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... -
APAC’s Bioprocessing Technology Ready, Regulatory Certainty Needed for Continuous Manufacturing Investment; China/Korea CDMOs Lead Adoption
BioProcess International USA Overview A BioProcess International article analyzes regulatory challenges for continuous and intensified bioprocessing adoption in the Asia Pacific (APAC) region. While hardware and software for perfusion bi... -
Continuous Chromatography & ICH Q13 Overcome Downstream Purification Challenges Amplified by Upstream Intensification
Separation Science Global Overview According to Separation Science, upstream bioreactor intensification, including N-1 perfusion seeding and high-density fed-batch, is creating new challenges for downstream purification. Continuous purif... -
Raman Spectroscopy Emerges as Key PAT for Real-time Metabolite Monitoring in Continuous & Perfusion Bioprocessing, Aligned with ICH Q13 Guidelines
Technology Networks Global Overview Process Analytical Technology (PAT) strategies are increasingly crucial for optimizing continuous and perfusion bioprocessing. Raman spectroscopy is emerging as the preferred in-line analytical techniq... -
FDA-Endorsed Process Analytical Technology (PAT) Revolutionizes Pharmaceutical Manufacturing Quality with Real-time Measurement
Technology Networks UK Overview This article elucidates Process Analytical Technology (PAT) as an FDA-endorsed framework for real-time measurement and control in pharmaceutical manufacturing. PAT fundamentally shifts quality assurance fr... -
Biomanufacturing Quality Control Transforms with Real-time PAT and AI Integration Under FDA ICH Q13 Guidance
Technology Networks UK Overview Process Analytical Technology (PAT) in biomanufacturing is undergoing a paradigm shift from endpoint testing to real-time, in-line measurement, driven by FDA's ICH Q13 guidance on continuous manufacturing,... -
N-1 Perfusion Culture & Pharma 4.0 Accelerate Bioprocessing Scale-Up with AI Optimization
Drug Discovery News USA Overview Integrating N-1 perfusion culture with Pharma 4.0 principles is significantly accelerating bioprocessing scale-up. AI and machine learning-driven predictive models optimize yields, while MES provides real...
1