Initial studies of the Pfizer/BioNTech COVID-19 vaccine demonstrated 100% efficacy in protecting against hospitalization, but that number slowly drops in six months to about 84%, Pfizer CEO Albert Bourla said. A study that has not undergone peer review found that a third dose of the vaccine raises antibody levels by a factor of 5 to 11 for adults, with older adults seeing larger gains.
Humoral responses to Pfizer/BioNTech's COVID-19 vaccine were at "frequent and high levels" among recipients of allogenic hematopoietic stem cell transplants, according to a study in The Lancet. The findings were based on data for antibody quantification for 88 patients who were vaccinated a median of 23 months after receiving stem cell transplants.
The US National Institute of Standards and Technology, the National Institute for Innovation in Manufacturing Biopharmaceuticals and US Pharmacopeia will collaborate on the development of measurement methods and reference materials for adeno-associated viruses for use as vectors in gene and cell therapies.
Demand for novel therapies is driving a shift in biopharmaceutical development and manufacturing from a blockbuster model to an emphasis on quality and value, says Mike Barrett, vice president of project delivery services at engineering firm CRB. Office, laboratory and research spaces are becoming more flexible so they can be changed without major investment, and technology is being selected based on priorities such as environmental sustainability or speed to market, Barrett says.
Kriya Therapeutics says its good manufacturing practice-compliant facility in North Carolina will begin producing gene therapies later this year. The company recently raised $100 million in a Series B round, which CEO Shankar Ramaswamy says "will be used to further develop our core technology platforms, expand our pipeline and advance our current programs in metabolic disease, ophthalmology and oncology."
Recent industrial pump innovations include advanced water management systems, high-tech sensors, improved seals and troubleshooting tools. A project to install improved seals at a food processing plant and a demand-driven supply system for a drinking water network are among six case studies that highlight opportunities for saving energy and money.
Danaher Corp. subsidiaries Cytiva and Pall are investing $1.5 billion at 13 manufacturing sites to accelerate expansion plans already underway. Cytiva expects to double cell culture media capacity at its Logan, Utah, site, and Pall will expand single-use manufacturing operations in China and open a new facility in Cardiff, Wales, to manufacture equipment for single-use bioprocessing, including bags, flow kits and tubing assemblies.
Biopharmaceutical companies' data integrity management programs are increasingly complex, costly and subject to human error as automated equipment generates more data points that must be verified, and off-the-shelf products may be an affordable way to manage risks, writes Peter Cusworth, account manager for industrial automation company Yokogawa. The cost of meeting data integrity requirements may appear to outweigh investments in newer equipment and systems, but "this attitude has been shown to have far-reaching complications, hitting share prices and big-name reputations," Cusworth warns.
South Korea's reliance on imported active pharmaceutical ingredients has increased significantly since 2017, according to the Korea International Trade Association. In 2019, 36.7% of Korea's API supply was from China, 13% was from Japan and 10.2% was from India, and the association says Korea should reorganize its API supply chain.
India's Department of Pharmaceuticals extended the application deadline to Aug. 31 for manufacturing key starting materials, drug intermediates, active pharmaceutical ingredients or medical devices under the production linked incentive scheme. The department also invited applications to produce ofloxacin under the PLI scheme.
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