Arranta Bio (“Arranta”), a leading contract development and manufacturing organization (CDMO) supporting advanced therapy pioneers, today announced plans to establish contract manufacturing capacity for messenger RNA (mRNA) vaccines.
Biotech Cleanroom Industry Articles
Boston Labs and Germfree Launch Mobile Cell and Gene Therapy (CGT) Manufacturing Platform
Clinical logistics and life science manufacturing leaders Boston Labs and Germfree Laboratories Inc. today announced their partnership to launch a new network of mobile CGT manufacturing facilities.
Precision Coating Announces Merger with N2 Biomedical to Expand Medical Device Coating Platform
Precision Coating, a leading medical coatings service provider to interventional, orthopedic, and advanced surgical markets, is pleased to announce a merger with N2 Biomedical, a Bedford, MA-based company.
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.
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.