Infectious disease expert Dr. Krutika Kuppalli says COVID-19 is affecting the response to Ebola virus cases in the Democratic Republic of Congo. The world's resources and heath workforce are strained, resulting in a shortage of funding for contact tracing, case management, community engagement and other prevention efforts, Kuppalli said.
Humanigen and Thermo Fisher Scientific have partnered to boost the company's manufacturing capacity for its drug lenzilumab as a treatment for COVID-19 in line with plans to apply for emergency use authorization. "Manufacturing preparation, precision and expertise are critical as we execute on an aggressive strategy, pending a potential EUA from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier," said Dr. Cameron Durrant, Humanigen's chairman and CEO.
An alternative vaccine strategy has helped researchers gain new insights into how to induce T-cell immunity in the respiratory tract, according to a study in the journal Cell Reports Medicine. "We didn't previously know how to elicit these tissue-resident memory cells with a safe protein vaccine, but we now have a strategy to stimulate them in the lungs that will protect against influenza," study author Marulasiddappa Suresh said.
More than 80% of biopharma executives and tech suppliers polled by BioPlan Associates reported considerable use of single-use bioprocessing technology, raising concerns about rising demand and possible shortages. Production of COVID-19 vaccines and therapeutics is likely to contribute to shortages, and smaller companies may have difficulties finding single-use systems, according to BioPlan managing partner Eric Langer.
Labeling violations are costly for pharmaceutical manufacturers, but compliance is laborious and time-consuming, write Julian Backhouse and Kiran Chinnalla of IQVIA. Artificial intelligence and machine learning can help pharma companies respond quickly to regulatory changes around the world, improve patient experience and give staff time to focus on innovation.
Pharmaceutical companies can implement basic cybersecurity fixes to thwart hackers targeting COVID-19 vaccine research and development, writes Jake Olcott, vice president of government affairs at BitSight. The company found that 17 top pharma companies that are developing COVID-19 vaccines have serious cyberissues, 16 of them have been exploited or infected with a botnet, and 14 have vulnerabilities.
Some COVID-19 vaccines need to be stored at minus 70 degrees Celsius, and US states are scrambling to find enough ultra-cold freezers. States have been told not to buy the freezers yet because storage requirements will depend on approvals, and the question could complicate vaccination of priority groups and in rural areas, but some experts say the problem could be mitigated by using distribution routes created for the H1N1 vaccine.
A study in The Lancet Neurology found that dual infection with the chikungunya and Zika viruses was associated with increased risk of stroke. The findings were based on an analysis of outcomes from 201 adults in Brazil with new-onset neurological disease in 2015 and 2016.
AskBio developed a recombinant adeno-associated virus manufacturing model for gene therapies that scales down upstream manufacturing and purification processes, enables early identification of candidates that can be scaled up and minimizes risk and the need for process changes. The company has tested the model and plans to use it in future products.
The pharmaceutical industry must focus on meeting the demands of consumers and regulatory bodies, but there are still ways manufacturers can also reduce their carbon footprint, writes Ben Churchill of Crowley Carbon. Make simple changes to reduce energy use, reuse resources such as water and consider other energy sources such as wind or solar energy, Churchill writes.
- Page 1