Medical Device Cleanroom News
Get the latest Medical Device Cleanroom News and updates below. Cleanroom Connect brings you the latest Medical Device Cleanroom News from around the world, featuring current topics and news in the medical device industry.
Biomanufacturing Plant Is First Of It’s Kind In The United States
A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. The next-generation biomanufacturing plant require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.
FDA Approves Anti-Cancer Drug For Advanced Paraganglioma
The U.S. Food and Drug Administration (FDA) has approved the first ever non-surgical treatment for the rare neuroendocrine cancers pheochromocytoma and paraganglioma. The approval was based on a multi-center trial led by researchers in the Abramson Cancer Center of the University of Pennsylvania and was granted to Progenics Pharmaceuticals for AZEDRA.
Platelet BioGenesis Moves to New Cambridge Cleanroom
Platelet BioGenesis (PBG), the leader in the production of functional human platelets (PLTs+™) from stem cells and the development of platelet-based therapeutics, announced it has moved into brand new lab space in Cambridge, MA. Located next to MIT, the newly renovated property puts Platelet BioGenesis in the heart of the most dynamic biotech cluster in the world.
Norovirus Vaccination Found by ASU Researchers
The study demonstrates that the new plant system for norovirus vaccine production is effective against the tenacious pathogen and that the versatile method could be used for the development of a broad range of novel vaccines. It is estimated that an effective vaccine against gastroenteritis could save billions of dollars in healthcare costs in the U.S. alone.
New Gene Therapy Treatment for Osteoarthritis
Osteoarthritis (OA) is a joint disorder that affects 28 million people in the United States. With no current disease-modifying therapy for OA, most patients rely on symptomatic relief to manage joint inflammation and chronic pain.
Immune System Fuel Puts the Brakes on Macrophages Damage
When tissue is damaged, one of the body’s first inflammatory immune-system responders are macrophages, cells which are commonly thought of as “construction workers” that clear away damaged tissue debris and initiate repair. However, prolonged inflammation promotes the progression of many diseases, including obesity.
New Sterile Dry Powder Injection Cleanroom by Wockhardt
With an aim to grow and further establish their international presence in pharmaceutical manufacturing, Wockhardt inaugurated a ‘state-of-the-art’ sterile dry powder injection cleanroom manufacturing facility for the production and packaging of sterile dry powder injection in Dubai. On approval of the new drug by US FDA, this manufacturing facility will be commissioned for commercial production.
Genomma Lab Receives US$100 million Financing Package
Genomma Lab will be able to focus on lowering its production costs, and thus offering more affordable medicines and products across the region.”, said Mr Maximo Juda, CEO of the Company. “Both multi-lateral institutions will not only provide long-term financing but also key strategic advice given their extensive industry expertise in pharma and environmental matters”, added Mr. Antonio Zamora Galland, CFO of Genomma Lab
Medical Device Single Audit Program – How Should You Prepare?
To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP) whereby recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of various regulatory agencies.
Atropine Autoinjector Reaches FDA Approval Safeguarding Troops from Nerve Agents
The Atropine Autoinjector initially received Emergency Use Authorization from the FDA in April 2017. Atropine is one of the most commonly used drugs for the treatment of chemical nerve agent poisoning. With the approved Atropine Autoinjector, U.S. troops can rapidly inject atropine into the thigh muscle following nerve agent exposure.
Almac Group Launches GMP High Throughput Peptide Manufacturing Service
Almac has manufactured multiple High Throughput batches of neoantigen derived peptides –branded by Almac as NeoPeptides™ – for compassionate use treatments, and for P-I clinical trials, from its Edinburgh facility. Over the course of the past ten months the facility has been upgraded and segregated to enable GMP supply.
New Biosensors For Implantable Sensing
Biosensors are devices that can detect biological molecules in air, water, or blood. They are widely used in drug development, medical diagnostics, and biological research. The growing need for continuous, real-time monitoring of biomarkers in diseases like diabetes is currently driving efforts to develop efficient and portable biosensor devices.
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Medical Device Cleanroom News
The Medical Device Cleanroom Industry supports the environmental cleanroom and controlled environmental systems for the Medical Device Cleanroom industry. The medical device industry is the study of medical apparatus, medical appliance, medical software, medical materials or other medical articles. Whether used in solidarity or in combination with technology or software. The Medical Device Cleanroom News curated on Cleanroom Connect specifically relates to new medical device trends, medical device products, medical device startups, and medical device innovations.
Medical Device Cleanroom News a key to Compliance
Common uses of medical devices are intended to be compliant by the specifications created by the original product manufacturer. These medical devices serve humans in the following circumstances:
- Disease Diagnosis, disease prevention, disease monitoring, or disease alleviation
- Injury diagnosis, injury treatment, injury monitoring, injury alleviation
- Physiological process monitoring, anatomy replacement or anatomy modification
- Technical administration of pharmaceutical agents, biologic agents, immunological agents
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