Category Archives: Manufacturing

The Shrinking CMO Industry

By Jim Miller. Exits from the CMO industry are a more recent development that seems to be picking up momentum. Examples of CMOs leaving the industry in the past year include the contract manufacturing units of Bayer and Boehringer-Ingelheim; Pharmalucence; and SCM Pharma. There have been two principal drivers of these developments: growing demand for […]
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FDA’s New Emerging Technology Team to Assist “Innovative Manufacturers”

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”.
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Pharma Manufacturing Investments Reflect Key Industry Trends

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Pharmaceutical Technology’s Cynthia Challener offers summary of selected investments in both small- and large-molecule manufacturing facilities during the last year. Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in […]
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Five Steps to Data Integrity

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity. In general, media tend to report on the most serious data integrity violations uncovered by regulators. Often when companies find similar issues through their own internal investigations, they remain confidential and unreported. It would, therefore, be presumptuous to assume violations reported on […]
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EU Steps Up Manufacturing Inspection Efforts

One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]
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