01.02.26 -- Is Charisma An API?

Stop the cycle of paper-based errors and batch record delays. Learn how a modular, compliance-first manufacturing system accelerates validation, enables real-time traceability, and shortens release cycles.

We are beginning to see a rise in the interest of developing “orphan drugs." Discover challenges and considerations associated with the expedited development and how to successfully work through them.

Still validating the manual way? With AI-powered CQV, you can reclaim hours lost to protocols and audit prep. What used to take weeks is now done in minutes.

A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.

While certain ingredients require sourcing abroad, partnering with a U.S.-based company that owns its manufacturing assets allows for direct oversight of product quality and supply reliability.

Find out how a low-code approach to MES systems delivers speed, flexibility, and compliance, empowering manufacturers to overcome bottlenecks and embrace digital transformation.

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Explore how a scientifically grounded framework for early-phase CMC development, integrating QbD and proactive risk management, helps de-risk drug development.

Wastewater incineration reduction and solvent recovery are two sustainable process techniques that can be built into the drug manufacturing workflow to significantly reduce carbon emissions and waste.

To accelerate COVID-19 vaccine production, a leading biologics contract manufacturer sought high-speed labeling machines that could be rapidly deployed.

Examine the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.