04.17.25 -- The Symphony Of Simulation: Mechanistic Modeling And Digital Twins In Biologics

Relying on fragmented data becomes problematic when teams need to dissect cell line performance data and that data is not in a digital backbone.

Here, we outline how the upstream and downstream workflows of the VirusExpress® platform for lentiviral vectors were optimized through the use of design of experiments and supplementary studies.

Annex 1 sets EU regulatory standards for sterile manufacturing, emphasizing contamination control, quality management, and risk prevention to enhance sterility, patient safety, and regulatory compliance.

In an industry where unplanned downtime during manufacturing can be catastrophic, having the right maintenance support for the highly specialized equipment supporting a biopharma workflow is crucial.

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

Discover how to prepare for an audit, from preparation and documentation to streamlined processes and digital validation, ensuring compliance and successful inspections in regulated industries

While practical quantum computing applications remain far away, quantum biosensing applications with real-world impact in areas like immunotherapy and diagnostics are near at hand.

Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

Learn how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.

AI-powered multiplexed imaging and analysis explore the tumor-immune microenvironment in colorectal adenocarcinoma, identifying potential biomarkers for therapeutic insights.

Digitalization has become crucial in the industry. Gain insight into how your manufacturing process can transition from paper to digital operations and aid in accelerating batch releases.

Explore a maturity model that was created to help you better understand where you are on your DataOps journey and where you need to go to achieve the results you expect.

Efficiency in bioprocessing and achieving rapid mixing across various viscosities is crucial for consistent biopharmaceutical product quality. Discover more about the benefits of this mixer.

Late-stage clinical trial failures usually result in exposure with regard to capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment?

Explore aqueous detergent selection criteria as it fits into three broad categories: function and efficacy, health and safety, and environmental.

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

Cleanroom systems are purposely designed to simplify the implementation of the aseptic manufacturing space that the industry needs to meet future sterile injectable capacity demand.

Learn about the role of single-use technology in advanced therapy manufacturing, why pharmaceutical manufacturers are switching to disposable technology, and more.

One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.