A thromboinflammatory state caused by an overactive immune system was associated with severe COVID-19 infection, based on a new study that probed how autoantibodies affect neutrophil extracellular traps when a patient has a COVID-19 infection.
Up to four months after being diagnosed with COVID-19, more than 25% of 150 patients were found to have elevated D-dimer levels, based on results in the Journal of Thrombosis and Haemostasis. Data also showed that 8% of patients had more than two times the upper limit of normal of D-dimer levels while being evaluated during their recovery phase.
Atara Biotherapeutics reported that its investigational, allogeneic Epstein-Barr virus-specific T-cell therapy tabelecleucel was beneficial for patients with relapsed or refractory Epstein-Barr virus-driven post-transplant lymphoproliferative disease, with over 80% of study patients who responded to treatment surviving two years after initial treatment. Results of the study were presented during the annual meeting of the European Society for Blood and Marrow Transplantation.
The investigational new drug application filed by Arcellx for its engineered T-cell therapy ACLX-001 has been granted FDA clearance. The treatment was developed as a treatment for adult patients with relapsed and refractory multiple myeloma.
A decline was noted in the incidence of COVID-19-related acute kidney injury from March to November 2020 based on data from 6,216 hospitalized patients in New York City. The results were presented during the National Kidney Foundation Spring Clinical Meetings.
Continuous flow chemistry, process intensification, automation, and mobile and distributed manufacturing promise to make manufacturing of active pharmaceutical ingredients and finished drugs more flexible and less expensive, potentially answering calls in the US, Europe and elsewhere for supply chain stability, industry experts say. However, regulatory barriers including criteria for good manufacturing practice certification will have to be addressed, according to a US National Academies of Sciences, Engineering, and Medicine report.
Sinovac Biotech's third COVID-19 vaccine plant has started culturing cells for making the vaccine's active ingredient in bulk, bringing Sinovac's capacity to 2 billion doses a year, the company says. Sinovac says more than 200 million doses of CoronaVac have been delivered, and more than 100 million doses have been administered worldwide.
Environmental monitoring is an essential component of good manufacturing practices, and monitoring environmental trends can help facility managers spot and correct looming problems with cleaning, disinfection and microbial contamination, writes Crystal Booth, a regional manager at PSC Biotech. Various regulations, guidelines and warning letters mention EM and trending, and facilities should track trends in nonviable particulates, active and passive viable air samples, surface samples, personnel, microorganisms, water systems and compressed gas systems, Booth writes.
Experts say the highest hurdle in viral vector production is low yields of functional capsids containing the desired genetic payload, essentially creating the need for a cell line for each manufacturing run. Scalable host cell lines, proprietary insect and mammalian cell lines, high-throughput platforms for cell culture and purpose-built manufacturing platforms are among the innovations that may improve production.
Regis Technologies completed a two-year project expanding its active pharmaceutical ingredient development facilities in Morton Grove, Ill. The expansion added laboratories equipped with an advanced variable air volume air system, a mass spectrometry suite, climate-controlled storage, reactors, process safety equipment and fume hoods.
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