11.07.25 -- Ethical AI And Collaboration With Kat Kozyrytska

Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

Learn about the Windsor Framework and how it addresses the challenges of medicine supply chains between the UK and the EU, creating stability and certainty in the post-Brexit world.

The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

Navigate the path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward.

Learn how turbulent jet mixing enables linear scalability, guaranteeing consistent nanoparticle quality from research to commercial production and accelerating product timelines.

Understand the opportunities and challenges that come with adopting faster, more precise approaches to microbiological testing.

Fragmented CQV systems hinder validation efforts, which risks compliance and slows progress. Discover how centralized platforms streamline processes, boost efficiency, and meet evolving regulatory demands.

Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing

Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.

Uncover how analytical tools assess the impact of production process choices and tissue sources on the quality of cell-derived extracellular vesicles (EVs).

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

ADCs with similar antibody sequences can behave differently due to linker and payload choices. Analytical tools reveal structural and stability differences critical to therapeutic performance.

Gain valuable perspectives on the future of biomanufacturing, including the impact of data science, automation, and continuous learning, shared by an experienced biophysics specialist in the field.

Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Hear from Dr. Fabio Luciani, Professor and Senior Researcher in Systems Immunology at the School of Medical Sciences and the Kirby Institute at UNSW Sydney about his recent research.

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.

This study compares the accuracy, precision, and cost-effectiveness of three different analytical methods for quantifying recombinant human antibodies produced in a CHO cell line.