Biotech Cleanroom Industry Articles

Signature Biologics™ Opens Expanded Manufacturing and R&D Headquarters in Irving, TX

Signature Biologics, LLC., today announced their expanded operations footprint to include a new 36,000 sq ft facility in Irving, TX. This newly constructed space mirrors Signature Biologics’ transparency in doing business with open floor plan and floor-to-ceiling views into its fully equipped manufacturing and R&D laboratory spaces.

Cytiva and Mycenax Biotech Build First Continuous Bioprocessing Lab in Taiwan

Cytiva, a global life sciences leader, has partnered with Mycenax Biotech Inc, a leading biopharmaceutical CDMO company, to launch Taiwan’s first continuous bioprocessing lab.

Artiva Biotherapeutics Builds New US Cell Therapy R&D and Manufacturing Facility

Artiva Biotherapeutics, an oncology company specializing in primary allogeneic natural killer (NK) cell therapies to treat cancer, announced on Aug. 12, 2021 an expansion of its US presence with a new R&D and GMP manufacturing facility in San Diego, Calif., for cell therapies.

Rentschler Biopharma lays the foundation stone for a new US production facility in the greater Boston area

New facility at the existing facility in Milford, MA, USA will significantly expand cGMP manufacturing capabilities and accelerate the clinical and commercial supply of vital biopharmaceuticals

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.

Neurophth Announces the Completion of GMP Manufacturing Facility for Gene Therapy Products

Neurophth Biotechnology Ltd., a fully-integrated genomic medicines company seeking to improve lives through the curative potential of gene therapies, announced the opening of its state-of-the-art manufacturing facility at the Phase II Suzhou Biomedical Industrial Park (BioBAY) in Suzhou, China.

Exoplanets Found by Scientists Where Life Could Develop Like on Earth

The researchers, from the University of Cambridge and the Medical Research Council Laboratory of Molecular Biology (MRC LMB), found that the chances for life to develop on the surface of a rocky planet like Earth are connected to the type and strength of light given off by its host star.

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.

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.

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