Navigating the Pitfalls of MSAT for Successful Technology Transfer: In the biopharmaceutical sector, MS&T responsibilities extend to both upstream and downstream processes. This includes optimizing cell culture conditions, managing bioreactor performance, and ensuring effective purification
FDA regulation of Artificial Intelligence (AI) and Machine Learning (ML) follows a risk-based framework focused on safety and effectiveness throughout the product lifecycle. As of mid-2025, the FDA has authorized over 1,250 AI-enabled medical devices, with nearly 80% used in radiology .
The pharmaceutical industry stands at a crossroads where regulatory expectations continue to evolve, patient safety remains paramount, and competitive pressures demand operational excellence. In this complex landscape, organizations …
The Raw Material Risks You Can’t Afford to Ignore: Ignoring raw material risks like unpredictable supply chains, political upheaval, or dwindling resource can seriously disrupt production, drive up costs, and weaken a company’s ability to bounce back.
The artificial intelligence revolution isn’t coming, it’s here. While only 13% of companies globally are ready to leverage AI and AI-powered technologies to their full potential, the organizations that prepare…