The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health-based exposure limits.
The Trump administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
Bioburden and endotoxin testing traditionally have been performed retrospectively, and only through sufficient validation and historical data is sufficient confidence developed. Online water bioburden analyzers (OWBAs) have the potential to eliminate sampling and testing errors via reduced manipulations.
As technology advances and experimentation with existing approved entities broadens, the use of “combinations” will continue, and the proper use of them will depend on regulatory professionals reminding development teams of the differences as data becomes available.
The EMA and the FDA reported a major issue regarding the detection of a genotoxic impurity, NDMA (N-nitrosodimethylamine), and subsequently NDEA (N-nitrosodiethylamine), in lots of valsartan, an API used to manufacture generic angiotensin receptor blockers. The API at issue was supplied by two Chinese companies and was later discovered in API manufactured by an Indian manufacturer.
The proposed text of the U.S.–Mexico–Canada Agreement (USMCA) is intended to replace the North American Free Trade Agreement (NAFTA), which has been in place since the mid-1990s. There have been some very strong reactions. Is the USMCA “an important step in bringing Mexico and Canada closer to high U.S. standards” or a crushing blow to patients that will “stifle biosimilar competition"? As with most things, the details will matter, and of course the House and Senate must still approve the agreement. It’s important to consider 1) Whether the 10-year exclusivity impacts the filing of biosimilar applications, 2) What this change means in terms of the prioritization of some medicines from a public policy standpoint, and 3) The impact the agreement has on efforts to make biosimilars more accessible in the U.S.
Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will look across large data sets and find correlations between obscure signals and events which the previous system could have missed.
In every tech transfer, each transfer point from one step to the next requires some piece of information, some material, some result, some decision, and/or some signed document.
Biopharmaceutical processes — and the technologies that enable them — have experienced remarkable progress in the past 30 years, since the first biopharmaceuticals were approved for human use. This article will highlight some of today’s top trends in bioprocessing, as this exciting field continues to flourish.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?”
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