Medical 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.

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.

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