Facility design challenges for small biopharma startups For small biopharma startups, the leap from groundbreaking discoveries in the lab to full-scale drug production is both exhilarating and daunting. While scientific innovation drives initial success, translating laboratory methods into manufacturing processes presents challenges beyond technical expertise. For all of the hurdles both compliance and technical rigor…
Navigating the new regulatory terrain pharma companies face with IRA and 340B
The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals…
No room for error: How a holistic quality management strategy can help pharma firms adhere to strict quality standards
Ever heard the phrase “one bad apple spoils the barrel”? The proverb rings especially true in pharmaceutical manufacturing, where even trace amounts of contaminants can have grave consequences for patient safety. “In the case of pharma, the stakes are so high that even the tiniest contaminants can endanger patients and result in wasted therapeutics, amounting…