FDA approves first switch from batch to continuous processing
For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug manufacturer’s change in their production method from batch to continuous processing. The new approval is for manufacturing Janssen’s HIV-1 drug Prezista (darunavir).
The FDA wants more drug makers to transition to continuous processing, which it says enables faster and more reliable production.
In a blog post setting out the benefits of continuous manufacturing, Lawrence Yu, the FDA’s deputy director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER), said that in some cases this “new and exciting technology” can cut production time from a month to a single day. The more efficient production of quality products can also drive down manufacturing costs and allow manufacturers to respond more quickly to changes in demand, potentially helping to prevent drug shortages.
NIH suspends production at two sterile facilities
The National Institutes of Health (NIH) has suspended production in two of its sterile manufacturing facilities after independent experts found that the laboratories were not in compliance with quality and safety standards.
Among the problems identified by officials from the U.S. Food and Drug Administration (FDA) in May 2015 were deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures. As a result of an evaluation, NIH has suspended production at the two facilities: a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.
Shire to expand manufacturing to Ireland
Shire plc plans to expand its global biotechnology manufacturing capacity over the next four years to meet growing demand. It will use flexible production strategies that will enable it to supply both clinical and commercial scale products for rare disease treatments.
Its new campus expects to create 400 permanent jobs on a 120-acre site at Piercetown, County Meath, Ireland. Construction of the new site will begin in mid-2016. The company plans for the new site to complement its US manufacturing operations.