In a remarkable advancement for the field of biotechnology, McMaster University and Sartorius have inaugurated a state-of-the-art bioprocessing automation laboratory at the university’s Faculty of Engineering, setting a new standard for bioprocess modeling, simulation, and advanced control. This
The US Food and Drug Administration (FDA) raised serious concerns about Sanofi's manufacturing facility in Framingham, Massachusetts, by issuing a Warning Letter for significant deviations from current Good Manufacturing Practice (cGMP) standards for drug substance production. This alarming
The ethical concerns surrounding the non-disclosure of genetic risks to participants in Alzheimer’s anti-amyloid drug trials have sparked significant debate. Eisai and Eli Lilly, the companies conducting these trials, were aware of the increased risk of brain swelling and bleeding in participants
Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine, providing the highest level of evidence for the efficacy and safety of new drugs and medical devices. However, traditional RCTs often face significant challenges, including high costs, complex governance, and
Precision medicine represents an innovative approach to disease treatment and prevention that is biomarker-guided and individualized. It incorporates an individual's genetic information along with other social health determinants such as environment and lifestyle. This approach enables healthcare
In a breakthrough development for cancer treatment and deep tissue imaging, researchers at Tokyo Metropolitan University have created a revolutionary dye. This innovative dye is derived from the bile pigment bilatriene and incorporates a unique ring structure designed to bind rhodium and indium
California, often recognized as a trendsetter in healthcare policy, continues to forge its path with several new laws aimed at improving various aspects of the healthcare system. As the country anticipates shifts in federal healthcare policy under President-elect Donald Trump, California's
Clinical trials are the backbone of medical advancements, but they face a persistent challenge: participant adherence. Non-adherence can skew results, impact outcomes, and undermine the effectiveness of health solutions. Enter digital adherence tools, which are revolutionizing the landscape by
The production of protein-based drugs is a cornerstone of modern medicine, offering treatments for a range of conditions from cancer to autoimmune diseases. Central to this process are Chinese hamster ovary (CHO) cells, which are widely used in the biotechnology industry for their ability to
A phase 1 clinical trial has brought new hope for patients with B-cell lymphoma, a type of blood cancer, through an innovative cell-based immunotherapy. Researchers from Washington University School of Medicine in St. Louis, along with other collaborators, have explored the safety and potential
