FDA regulations, ISO standards, and GHTF guidance documents do not prescribe the number of runs required for process validation activities. Industry has typically used three batches during the process performance qualification phase to demonstrate that a process is capable of consistently delivering quality product, but the so-called "rule of three" is no longer appropriate for process validation activities.
In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.
According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.
A Powerful Choice: Selecting Potency Assays for Biologics. Will it be animal models, cells, or chemical assays? The decision can make or break product success.
The FDA’s approval of Otsuka Pharmaceutical’s Abilify MyCite for certain psychiatric conditions — a first for digital medicine —willl be seen as a landmark in patient-centered care. Over time, it can help solve three core problems bedeviling the development and the delivery of healthcare around the world.
Among the current and emerging topics of interest to the biopharma industry, quality metrics, quality culture, and data integrity are of particular concern to both the companies and regulatory authorities. To understand how these three topics relate to each other, it is important to understand some of the history that led up to today’s environment.
This is the second in a series of six articles intended to provide a holistic primer on the field of quality risk management (QRM). This installment reviews the origins of pharmaceutical risk management and regulatory thinking that led to the establishment of QRM as a unique discipline in pharmaceutical development and manufacturing.
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?”
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.
Disposable products continue to be a hot topic in biomanufacturing, as they increasingly penetrate clinical- and commercial-stage manufacturing and are sought after for their process efficiencies. In fact, when we asked the 450 global subject matter experts and senior participants on our Biotechnology Industry Council™ to identify the critical trends in bioprocessing for 2013, 22% cited aspects associated with implementation of single-use system integration. These ranked narrowly behind need for downstream processing optimization, and analytical methods development (each at 24%). By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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