One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules...
- One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free of contamination, FDA documents show, including twice this year.
Growth in obesity medicines and complex biologic therapies is fueling demand for U.S. contract manufacturers like Thermo Fisher. But two manufacturing experts say the plant's 10-year audit record gives them reason to be concerned about the company's approach to quality control. One issue identified was Thermo Fisher had not provided the studies backing up how it measured and set thresholds for bubbles that can occur in injectable medicine. Such bubbles can cause deadly blood blockages in veins or arteries.
The FDA conducts thousands of audits per year but time between visits to a plant varies. It does prioritize plants with sterile manufacturing operations such as this one. Moderna and CSL both said they were not manufacturing vaccines at that plant during either FDA visit. "Contract manufacturing will likely continue to be an above market growth driver for Thermo because of the underlying market demand," said Deutsche Bank analyst Justin Bowers.
FDA Manufacturing Plants Square Foot Plant Parenteral Drug Association
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
After years of advocacy by a pediatrician, all Nunavut babies to get RSV immunizationThe territory will give infants Nirsevimab, a single-dose antibody injection with the brand name Beyfortus, that was authorized by Health Canada in April, 2023
Read more »
After years of advocacy by a pediatrician, all Nunavut babies to get RSV immunizationThe Nunavut government says it will provide immunization against respiratory syncytial virus to all infants in the territory this fall, a policy change that one pediatric infectious diseases specialist has been advocating for decades.
Read more »
Ontario, Quebec to offer RSV shots for all newborns as other provinces stick to current approachCiting costs, none of the Western provinces will provide the vaccine to newborns this season
Read more »
Protection against RSV coming soon for all infants in Ontario, Quebec, NunavutThis fall and winter, Ontario, Quebec and Nunavut will offer the newer monoclonal antibody nirsevimab — approved by Health Canada in the spring of 2023 — to all babies going through their first RSV season.
Read more »
Here’s how to get protection in Ontario against RSV this winterRespiratory syncytial virus, or RSV, season is just a few months away, but new vaccine options have already arrived for Ontario residents who may be vulnerable to the winter bug.
Read more »
Here’s how to get protection in Ontario against RSV this winterRespiratory syncytial virus, or RSV, season is just a few months away, but new vaccine options have already arrived for Ontario residents who may be vulnerable to the winter bug.
Read more »