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
In an optimistic outlook at the 43rd JPM Conference in San Francisco, Thermo Fisher CEO Marc Casper underscored the firm's strategic adaptations and growth initiatives tailored to meet surging demand for GLP-1 diabetes and weight loss products. Thermo Fisher Scientific's extensive
The contract development and manufacturing organization (CDMO) industry has seen significant advancements and partnerships as of January 2025. With a focus on large molecules and advanced therapies, this article delves into the latest developments, highlighting key trends, common themes, and
The Blood and Cell Advocacy Register (BCAR) is a newly launched consortium that aims to revolutionize the development and commercialization of advanced therapy medicinal products (ATMPs). Formed in December 2024, BCAR brings together experts and organizations from the blood and cell industries to
The field of biochemical engineering is witnessing an innovative approach with the development of fine-bubble engineering techniques. By focusing on the manipulation of both nanobubbles (NBs) and microbubbles (MBs), researchers aim to improve the efficiency and effectiveness of various bioprocess
The landscape of therapeutic drugs is undergoing a transformative phase, driven by significant strides in bioprocessing technologies and innovative biotechnological advancements. One of the most notable developments in recent years has been the shift towards personalized medicine, which tailors
