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Quality Matters

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  • Joseph Baker
  • October 31, 2014 02:02:33 AM
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A Little About Us

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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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...


USP Convenes Global Biologics Summit to Identify Challenges to Quality Biologics Medicines

USP Convenes Global Biologics Summit to Identify Challenges to Quality Biologics Medicines U.S. Pharmacopeia (USP) brought together preeminent thought leaders from industry, global health organizations, regulatory agencies, standards setting organizations and other stakeholders at its virtual Global Biologics Summit on June 11, 2020. Discussions centered around challenges in developing and manufacturing quality biologics in an increasingly global pharmaceutical landscape. Biologics...


Quality standards for efficiency in drug development and manufacturing

Quality standards for efficiency in drug development and manufacturing During the COVID-19 pandemic, we have become acutely aware of how precious time is and the potential repercussions of delays or inefficiencies. The healthcare and pharmaceutical industries along with governments and regulatory bodies around the world, have responded with an unprecedented sense of urgency to develop therapeutics that treat and prevent SARS-COV-2 infection. The development of treatments in...


Applying lessons from Ebola to the COVID-19 pandemic: Strengthening African health systems while scaling up testing

Applying lessons from Ebola to the COVID-19 pandemic: Strengthening African health systems while scaling up testing As African nations begin to ease lockdown restrictions, health systems are bracing to prevent the novel coronavirus from spreading rapidly through their populations. Many countries across the continent – such as Ghana, Kenya, Nigeria, Rwanda, South Africa, and Uganda – were ahead of the curve in taking steps to slow the spread of the virus more swiftly than other...


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