Nelson Labs and Sterigenics Germany GmbH, announced today the opening of State-of-the-Art Laboratory and Expand Sterilization Cleanroom Facilities
Medical Device Cleanroom Industry Articles
Nelson Labs® and Sterigenics® Open State-of-the-Art Laboratory and Expand Sterilization Facilities to Meet Growing Customer Demand in Europe
Nelson Labs and Sterigenics Germany GmbH, announced today the opening of a newly expanded, center of excellence for microbiological laboratory testing as well as increased sterilization capacity in their Wiesbaden, Germany facilities. This expansion will address the significantly increased demand for these services by the medical device and pharmaceutical industries.
Altasciences Continues Formulation, Manufacturing, and Analytical Services Facilities Expansion
Altasciences today announced the continued expansion of their formulation, manufacturing, and analytical services facilities in Philadelphia, PA.
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.
Nanomachine Robot Goes To Battle With Tuberculosis
The Brock team’s latest technology builds on an earlier version of the microscopic robot — called the three-dimensional DNA nanomachine — they created in 2016 to detect diseases in a blood sample within 30 minutes.