Manufacturing

Biogen Lupus Drug Earns FDA Breakthrough Designation
Management & Regulatory Biogen Lupus Drug Earns FDA Breakthrough Designation

For individuals grappling with the relentless and often disfiguring effects of cutaneous lupus erythematosus, the path to effective treatment has been long and fraught with limited options, but a significant development from Biogen offers a new beacon of hope. The U.S. Food and Drug Administration

Is Samsung's US Move a Game-Changer for Biopharma?
Management & Regulatory Is Samsung's US Move a Game-Changer for Biopharma?

The intricate global network that delivers life-saving medicines has proven remarkably fragile in recent years, prompting a fundamental rethinking of how and where these complex therapies are produced. In this context, Samsung Biologics' recent acquisition of a major US-based manufacturing facility

Enhertu Wins FDA Approval for Breast Cancer Treatment
Management & Regulatory Enhertu Wins FDA Approval for Breast Cancer Treatment

For the first time in more than a decade, the therapeutic landscape for newly diagnosed metastatic HER2-positive breast cancer has been fundamentally altered by a landmark U.S. Food and Drug Administration decision. The agency has officially approved a combination therapy featuring Enhertu and

Flow Chemistry, AI, and NMR Redefine API Production
Tech & Innovation Flow Chemistry, AI, and NMR Redefine API Production

At the forefront of pharmaceutical innovation, Ivan Kairatov is reimagining how essential medicines are made. As a leading expert in biopharma, his work merges the precision of continuous flow chemistry with the intelligence of advanced AI and real-time analytics. In a landscape reshaped by global

Rentschler and Coriolis Unite for Biopharma Innovation
Biotech & Bioprocessing Rentschler and Coriolis Unite for Biopharma Innovation

What if the complex journey of turning a groundbreaking biologic into a life-saving therapy could be transformed into a streamlined, efficient process? In a world where biopharmaceutical development faces unprecedented challenges, a powerful collaboration between Rentschler Biopharma and Coriolis

New Agitation Stress Model Boosts Biologics Stability Testing
Biotech & Bioprocessing New Agitation Stress Model Boosts Biologics Stability Testing

I'm thrilled to sit down with Ivan Kairatov, a seasoned biopharma expert with a wealth of experience in research and development. With a sharp focus on technology and innovation, Ivan has been at the forefront of advancing biologics formulation, particularly in tackling the complex challenges of

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