Production & Manufacturing

The modernization of regulatory frameworks is becoming essential to support the pharmaceutical industry’s transition toward advanced production models and to ensure the resilience of global supply chains. As innovative manufacturing technologies emerge, traditional oversight mechanisms must evolve to maintain...

The development of a new pharmaceutical manufacturing site has traditionally been a multi-year undertaking, involving a complex sequence of design, construction, and rigorous validation. For companies operating in the fast-moving cell and gene therapy sector, this traditional timeline is...

The final stages of the pharmaceutical manufacturing process, where the therapeutic product is filled into its primary container and prepared for delivery, have long been dominated by high-speed lines designed for millions of identical doses. However, the emergence of...

The development of Chimeric Antigen Receptor T-cell (CAR-T) therapy has provided a new and powerful tool for the treatment of hematological malignancies, offering hope to patients who have exhausted all other therapeutic options. However, the logistical and technical challenge...

The rapid expansion of the gene therapy sector has created a critical challenge in the production of viral vectors, the specialized vehicles used to deliver genetic material to target cells. As more therapies move from early-phase clinical trials toward...

The logistical and technical complexity of producing personalized medicines has reached a point where traditional batch testing methods are no longer sufficient to meet the needs of a growing patient population. In conventional pharmaceutical production, a product is manufactured...

A new research project from the Johns Hopkins Bloomberg School of Public Health has identified a pharmaceutical industry practice that could be a significant factor in global health disparities. Published in PLOS Global Public Health on July 07, 2026,...