The pharmaceutical industry stands on the brink of a technological revolution with the recent release of the Good Automated Manufacturing Practice (GAMP) Artificial Intelligence Guide by the International Society for Pharmaceutical Engineering (ISPE). As pharmaceutical companies increasingly turn
The cell and gene therapy (CGT) market is undergoing rapid expansion as it transforms healthcare with innovative treatments for previously incurable diseases. This exhilarating growth is projected to reach $28 billion by the year 2030, marking a significant milestone. Experts attribute this
With a wealth of experience in biopharma and a keen eye for technological advancement, Ivan Kairatov stands at the forefront of innovation in the industry. Today, he shares his insights on the FDA's recent decision to publish complete response letters (CRLs), a move designed to enhance transparency
The One Big Beautiful Bill Act, signed into law by President Donald Trump, has polarized opinions in the healthcare community due to its sweeping changes. Central to the apprehension is its significant reduction in Medicaid spending and the eradication of Affordable Care Act subsidies. These
Amid growing health crises and increasing global competition in pharmaceuticals, a novel FDA initiative aims to fast-track drug reviews by slashing approval times for essential medicines. Can this new approach significantly impact domestic drug manufacturing, or does it introduce unprecedented
In a decisive leap toward revolutionizing gene therapy, ProBio has unveiled its cutting-edge facility in Hopewell, New Jersey. This facility is poised to become a key player in the production of high-quality plasmid, lentiviral, and adeno-associated viral vectors tailored for genomic medicine. With
