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.
Dun & Bradstreet is partnering with the University of St.Gallen in Switzerland to conduct research in global pharmaceutical manufacturing quality management practices. The research project is designed to integrate the assessment of pharmaceutical quality management maturity into the FDA's Center for Drug Evaluation and Research program related to comprehensive surveillance of site and product quality. Participants will receive a no-cost benchmarking report. Full Story: Dun & Bradstreet
The pharmaceutical sector discovered supply chain gaps and vulnerabilities when the COVID-19 pandemic took hold, but in many ways the industry is thriving amid development of treatments and vaccines for the disease and the success of the rapid pivot to working online. Research and development budgets are growing, sales are strong, and some companies are expanding to accommodate the uptick in demand.
To improve patient health care and to ensure efficiency in lab medicine practices, laboratorians from Penn State Hershey Medical Center conducted a review of their testing sendouts to determine how they impact patient care, determine the costs involved and identify which vendor is most cost-competitive.
Timothy Ray Brown, the first person with HIV considered cured of the virus that causes AIDS after receiving a bone marrow transplant from a donor with a gene that confers natural resistance to HIV, says his leukemia has recurred, and he is receiving hospice care. "It opened up doors that weren't there before," Brown said of his transplant.
A genetic study on the preprint server MedRxiv that has not yet gone through peer review finds continued mutation in the novel coronavirus based on an analysis of more than 5,000 genetic sequences. "Although we don't know yet, it is well within the realm of possibility that this coronavirus, when our population-level immunity gets high enough, this coronavirus will find a way to get around our immunity," said virologist David Morens at the National Institute of Allergy and Infectious Diseases.
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.
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