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Amgen and Dr. John Petricciani Explain Why Precise Manufacturing of Biological Medicines Matters

Manufacturing matters for all drugs but especially so for biological medicines, which are more complex structurally and more difficult to characterize, produce and reproduce than most pharmaceutical medicines. Small variations in the manufacturing process have the potential to alter a biological medicine’s efficacy or safety and ultimately its availability.

To help physicians, pharmacists, payers and policymakers learn more about the complexity and importance of manufacturing biological medicines, Amgen has partnered with John Petricciani, MD, president of the International Alliance for Biological Standardization, to launch the Manufacturing Matters educational initiative.

“As new biological medicines become available around the world, healthcare professionals face an increasing number of choices when selecting an appropriate treatment,” said Dr. Petricciani. “At the same time, issues related to drug manufacturing including contamination, counterfeiting, and shortages have occurred and can compromise product quality, supply, and ultimately the health and well-being of patients prescribed these medicines.”

Dr. Petricciani added, “Healthcare professionals and others need to be aware of the importance of the manufacturing process for safe, effective, and reliably available biological medicines. The track record of the manufacturer should be considered when choosing a biological medicine.”