Pharmaceutical Cleanroom Industry Articles

Novatek Requalified as an “Approved Supplier” for Boehringer Ingelheim Aseptic Manufacturing Facilities

Novatek Requalified as an approved supplier for Boehringer Ingelheim, a global leader in healthcare. Novatek regulatory compliant quality solutions is used at Boehringer Ingelheim for its human pharma, animal health and biopharmaceutical aseptic (sterile) manufacturing sites worldwide.

Freudenberg Medical Expands Costa Rica Operations

Freudenberg Medical, a global contract design and manufacturing provider to the medical device industry, is expanding its manufacturing operations in Alajuela, Costa Rica. The expansion project adds 8,600 square feet to the existing facility which includes construction of an additional ISO Class 7 cleanroom for catheter manufacturing and assembly, molding, extrusion, and packaging, as well as added office space. New technology includes an advanced thermoplastic extrusion line which can produce tubing from 4 inches to 170 inches long with capacity of up to 1 million parts per month, plus additional injection molding machines.

Prenetics Signs Multi-million Dollar Collaboration with Oxford University for Advanced Molecular Diagnostics

Prenetics Limited, a global leader in diagnostics and genetic testing, Oxford University and Oxford Suzhou Centre for Advanced Research (OSCAR) have signed multi-million dollar collaboration agreements to further develop the award-winning OxLAMP™ technology, a rapid, molecular testing technology for infectious diseases.

ILC Dover Defines the Future of Sterile Manufacturing with the soloPURE™ Flexible Aseptic Isolator

soloPURE™ provides a closed, Grade-A, aseptic environment for fill finish activities requiring positive and negative pressures, giving organizations with facility restraints or expensive closed-barrier systems a better way to handle sterile potent powders, including products previously thought to be “out of reach” in conventional barrier systems.

Biosensor Chips based on Copper and Graphene Oxide

Biosensor Chips based on Copper and Graphene Oxide

Russian researchers from the Moscow Institute of Physics and Technology have developed biosensor chips of unprecedented sensitivity, which are based on copper instead of the conventionally used gold. Besides making the device somewhat cheaper, this innovation will facilitate the manufacturing process.

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Cardiology Laboratory Serves Bayer Strategic Alliance

Cardiology Laboratory Serves Bayer Strategic Alliance

Bayer Strategic Partnership formed. Bayer and the Broad Institute of MIT and Harvard announced the launch of the joint Precision Cardiology Laboratory, which will pursue novel scientific insights to enable the development of new therapies for patients with cardiovascular diseases such as heart failure.

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Machine Learning Sifts & Searches Complex Scientific Data

Machine Learning Sifts & Searches Complex Scientific Data

A team of researchers from the Department of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab) and UC Berkeley are developing innovative machine learning tools to pull contextual information from scientific datasets and automatically generate metadata tags for each file. Scientists can then search these files via a web-based search engine for scientific data, called Science Search, that the Berkeley team is building.

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MOF Nanoparticles Used to Deliver Killer Protein to Cancer

MOF Nanoparticles Used to Deliver Killer Protein to Cancer

In our design, self-assembly of MOF nanoparticles and encapsulation of proteins are achieved simultaneously through a one-pot approach in aqueous environment. The enriched metal affinity sites on MOF surfaces act like the buttonhook, so the extracellular vesicle membrane can be easily buckled on the MOF nanoparticles.

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Vertex Pharmaceuticals Acquires CTP-656 from Concert Pharmaceuticals for the Treatment of Cystic Fibrosis

Vertex Pharmaceuticals Acquires CTP-656 from Concert Pharmaceuticals for the Treatment of Cystic Fibrosis

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has signed a definitive asset purchase agreement to acquire CTP-656 from Concert Pharmaceuticals (Nasdaq: CNCE). CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis (CF). As part of the agreement, Vertex will pay Concert $160 million in cash for all worldwide development and commercialization rights to CTP-656.

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Cystic Fibrosis Therapy Improved by Lipid-Based Nanoparticles

Cystic Fibrosis Therapy Improved by Lipid-Based Nanoparticles

Researchers at Oregon State University and Oregon Health & Science University are working on a treatment that holds great promise for improving the lives of cystic fibrosis patients. Cystic fibrosis is a progressive genetic disorder that results in persistent lung infection and afflicts 30,000 people in the U.S., with about 1,000 new cases diagnosed every year.

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HPAPI Facility launches for production of the highest class of HPAPI

HPAPI Facility launches for production of the highest class of HPAPI

Minakem’s HPAPI production will be carried out with an Occupational Exposure Limit (OEL) below 0,1μg/m3/8h. This emphasis on Environment, Health and Safety (EHS) reflects Minakem’s more than 20 years’ experience in continuously monitoring and controlling hazardous working environments, marking its leadership in this area.

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New State-of-the-Art Plasma Manufacturing Facility

New State-of-the-Art Plasma Manufacturing Facility

Shire plc, the global biotechnology leader in rare diseases, announced today that the United States Food and Drug Administration (FDA) has approved the company’s first submission for its new plasma manufacturing facility near Covington, Georgia for the production of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI).

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