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Official blog of US Pharmacopeia (USP), sharing unique viewpoints on the public-health impact of worldwide efforts to promote the quality and integrity of medicines, food ingredients and dietary supplements. Writers include scientists, staff, volunteer experts and representatives of USP member organizations.
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Ensuring quality COVID-19 vaccine delivery through the ‘last mile’Ensuring quality COVID-19 vaccine delivery through the ‘last mile’ The COVID-19 pandemic has presented unprecedented challenges around the world, including to national public health systems and the international biopharmaceutical industry. The first few months of the pandemic exposed long-standing vulnerabilities in the global supply chain for medical products, resulting in wide-spread shortages of critical medicines, hand sanitizer, personal protective equipment (PPE), and...
Breeding a superbug: how poor-quality medicines fuel AMR
Breeding a superbug: how poor-quality medicines fuel AMR Another public health crisis looms in the wake of the COVID-19 pandemic. Antimicrobial resistance (AMR) has gained increasing attention over the past several years; earlier this year, the World Health Organization (WHO) recognized AMR as 1 of 13 urgent challenges for the decade. By 2050, approximately 10 million deaths per year may result from ineffective antimicrobials, and the global economic impact between now and 2050 is...
Ignore the politics. Trust the science.
Ignore the politics. Trust the science. Recent politicization of the COVID-19 vaccine development and approval process has led to a concerning loss of confidence in vital governmental institutions. Each day that goes by, the picture seems to grow darker. Politicians criticize scientists without cause. Pundits decry public health measures that have been proven to save lives. People increasingly lose faith in the people and institutions that have been designed to protect them from...
Glycosylation in monoclonal antibody treatments for COVID-19
Glycosylation in monoclonal antibody treatments for COVID-19 COVID-19 is transforming our ways of thinking about the development, manufacture and delivery of critical medicines to patients around the world. Recognizing that successful development and testing of an effective vaccine against COVID-19 will take time, many are keeping a close watch on monoclonal antibody (mAb) treatment candidates as viable weapons for staving off the pandemic. The U.S. Department of Justice (DOJ)...
The Role of Standards in Supporting Quality Vaccines Manufacturing and Distribution
The Role of Standards in Supporting Quality Vaccines Manufacturing and Distribution The scale and speed of the global vaccine research and development effort in response to COVID-19 is unprecedented. Researchers are exploring many different types of platforms for the development of COVID-19 vaccines, from the more traditional live attenuated virus and inactivated virus approaches, to recombinant protein antigen candidates, to newer approaches such as nucleic acid vaccines, like...
Accelerating Development and Building Trust in COVID-19 Vaccines With Public Quality Standards Jaap Venema, Ph.D., USP Chief Science Officer
Accelerating Development and Building Trust in COVID-19 Vaccines With Public Quality Standards Jaap Venema, Ph.D., USP Chief Science Officer Epidemiologists are consistently asserting that herd immunity of at least 60% of the population will be required to stem the large number of illnesses and deaths from COVID-19. Herd immunity can happen in two ways. One, through exposure and infection of the virus or two, through immunization. Of these two options, immunization clearly is the...
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