Sanofi’s Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, MA was named the Overall Award winner at the ISPE virtual annual meeting.
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The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.
Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA.
Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.
With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.
NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.
The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.
Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.
Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.
Joerg Ahlgrimm has left Lonza and is now leading The Discovery Labs’ mission to establish a powerhouse for cell and gene therapy development and manufacturing in the Philadelphia area.
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Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.
The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.
The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.
Branching out from roots in industrial biotechnology, Riffyn Data Systems (and its CEO Tim Gardner) is taking the message of data-driven process improvement to biopharma.
The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.
The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.
The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.
Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.
The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.
The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.
The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.
The acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.
Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture.
Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.
The new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.
The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.
A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.
The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).
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