A process that joins two solid reactants using interlocking screws to grind the materials together for extrusion could save manufacturers money and improve sustainability, researchers report in ACS Sustainable Chemical & Engineering. The process is in use by food and plastics manufacturers, but more research is needed before it becomes common in pharmaceutical manufacturing, researchers said.
Digitizing paper records and automating some laboratory tasks could improve regulatory compliance for pharma labs, especially as regulators increasingly prioritize data integrity. One way is to use data process mapping to reduce vulnerabilities.
Egypt is the latest country to reach a deal with Russia for Sputnik V COVID-19 vaccine and will receive 25 million doses. Russia will also supply Mexico, Brazil, India, Uzbekistan and Nepal with the vaccine, which was licensed by Russian regulators and is being tested on 40,000 Russians.
A trial assessing the investigational rheumatoid arthritis drug otilimab as a treatment for COVID-19 in patients with severe lung disease has begun with a patient at the UK's Manchester Royal Infirmary. GlaxoSmithKline is funding the study to determine whether the drug can stymie cytokine storms that occur in severe COVID-19 cases.
A report from the American Academy of Pediatrics showed that children of all ages now make up 10% of all COVID-19 cases in the US, increasing from 2% in April. Another report in the CDC's Morbidity and Mortality Weekly Report showed that the COVID-19 incidence among school-age children began rising when many returned to school in early September, and that the average weekly incidence of COVID-19 was about twice as high in youths between ages 12 and 17 at an average of 37.4 cases per 100,000 children, compared with those 5 to 11 at 19 cases per 100,000.
Obstacles to participation in trials of drug candidates for myelodysplastic syndromes include age, distance and comorbidities, according to researchers whose study in the journal Cancer compared patients with MDS who enrolled in trials with patients who did not. "Strategies to maximize accessibility include involving community providers at the design phase and providing patient navigation assistance throughout the study," study leader Dr. Charlotte Brierley of the University of Oxford said.
Adial Pharmaceuticals' Assure/FaStep COVID-10 IgG/IgM Rapid Test Device was granted emergency use authorization by the FDA. The assay uses a sample of blood from a fingerstick at the point of care and gives results in about 10 minutes.
Johnson & Johnson and Grand River Aseptic Manufacturing have entered a manufacturing deal to boost production capacity for J&J's COVID-19 vaccine candidate as it prepares to produce up to 1 billion doses next year. GRAM will manufacture and provide finished vials of the company's single-dose vaccine candidate.
A study by researchers at Heinrich Heine University and the University of Wuerzburg suggests pharmaceutical manufacturers should conduct sublimation tests when freeze-drying highly potent active pharmaceutical ingredients if new components are added to the process. The study examined the use of two protective bags during the freeze-drying process and found both affected drying conditions in different ways.
Pharmaceutical manufacturers looking for ways to improve their sustainability efforts should consider reducing energy consumption in steam systems, writes Angelo Giambrone, business development manager at Spirax Sarco UK. A system audit and an energy-monitoring system can also lead to decreases in consumption and costs, Giambrone writes.
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