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.
Medical Cleanroom Industry Articles
ISPE Boston Product Show Coming to Gillette Stadium
The Annual ISPE Boston Product Show is the premier one-day biopharmaceutical show in the Northeast and the flagship event of the ISPE Boston Area Chapter.
Olympus ViziShot 2 FLEX 19 G EBUS-TBNA Needle Helps Guide Lung Cancer Treatment
Olympus announced today the results of a pilot study showing the safety and effectiveness of the ViziShot 2 FLEX 19 G EBUS-TBNA Needle in gathering tissue samples critical to guiding treatment of non-small cell lung cancer (NSCLC).
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.
Injection Molding Medical Capability Investment by Graham Partners
Private equity firm Graham Partners has entered injection molded medical goods with an investment in Medbio LLC of Grand Rapids, Mich. Graham Partners acquired a majority interest in Medbio, effective July 18 for undisclosed terms, according to Graham managing principal Joe Heinmiller.
Artificial Embryo Created From Stem Cells Achieves Gastrulation
The creation of artificial embryos has moved a step forward after an international team of researchers used mouse stem cells to produce artificial embryo-like structures capable of ‘gastrulation’, a key step in the life of any embryo.