Phlow Corp. and USP Announce Strategic Alliance Focused on Pharmaceutical Continuous Manufacturing to Increase…

first_img By Digital AIM Web Support – February 22, 2021 Local NewsBusiness Twitter RICHMOND, Va.–(BUSINESS WIRE)–Feb 22, 2021– Phlow Corp., a public benefit essential medicines solutions provider, and the United States Pharmacopeia (USP) today announced a strategic alliance to develop a new laboratory that will certify and validate Pharmaceutical Continuous Manufacturing processes resulting in affordable, high-quality, U.S.-manufactured essential medicines. Throughout its 200-year history of setting standards for medicine quality, USP has been providing validated scientific methods used by manufacturers and regulators to determine what “good quality” looks like. The methods developed through this strategic alliance will be available for use by other domestic generics manufacturers to encourage broader adoption of Pharmaceutical Continuous Manufacturing in order to strengthen the U.S. drug supply. USP, a global, scientific not-for-profit organization located in Rockville, Maryland, develops public standards that establish the quality expectations for medicines, collaborating with scientific experts from the academic, industry, and healthcare practitioner communities along with the U.S. FDA. The alliance will facilitate Phlow’s application of “flow” chemistry and other continuous advanced manufacturing processes to produce the crucial ingredients that enable domestic, end-to-end drug manufacturing of essential medicines that have been or are at risk of being in shortage thereby contributing to a more resilient medicines supply chain. “Phlow has embarked on a bold mission to provide access to affordable, high-quality essential medicines for every American,” said Eric Edwards, M.D., Ph.D., co-founder, president and CEO of Phlow. “We are fixing the broken essential medicines supply chain by creating a solution that is 100% U.S.-based and fully integrated. Our success, which is made possible by partners like USP, is achieved only when every human being has access to the most important medicines necessary to sustain life and conquer disease.” “When crises such as natural disasters, geopolitical strife including barriers to trade and pandemics like COVID-19 arise, major interruptions in the global supply of quality medicines have an impact on American patients,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “Pharmaceutical Continuous Manufacturing poses several advantages over traditional batch manufacturing, especially during supply disruptions. These include the availability and use of real-time data to accelerate manufacturing scale-up and help improve medicine quality, enabling more efficient and nimble production of essential medicines and strengthening the overall supply chain. In addition, we hope that USP’s work with Phlow will help pave the way for the pharmaceutical industry to apply continuous manufacturing more broadly for the generic medicines so many patients rely upon.” As part of the alliance, USP scientists will be employed at a new laboratory facility operated by USP that will be developed onsite at the Virginia Biotechnology Research Park, which includes Virginia Commonwealth University’s Medicines for All Institute. Phlow currently leverages the advanced manufacturing processes developed by Virginia Commonwealth University’s Medicines for All Institute to produce active pharmaceutical ingredients for essential medicines that are in short supply. The new USP laboratory will be co-located with the R&D Laboratories at Phlow and the Virginia Commonwealth University’s Medicines for All Institute to support analytical process development and testing designed to improve efficiency in cost and time to produce essential medicines. Laboratory facilities and instruments in USP’s Rockville laboratory will also be used to expand capabilities and capacity for other analytical and testing projects. “Phlow’s partnership with the USP, working alongside the Virginia Commonwealth University’s Medicines for All team represents another key resource in our efforts to strengthen our supply chain for essential medicines,” said Frank Gupton, Ph.D., co-founder of Phlow, chair of Virginia Commonwealth University’s (VCU) Department of Chemical and Life Science Engineering and CEO of the Medicines for All Institute. “USP is the recognized leader in quality standards for pharmaceuticals and their commitment to this effort underscores the importance that we all place on delivering medicines that are of the highest quality. We look forward to our collaboration with USP and Phlow in this important initiative to secure onshore manufacturing in the U.S.” The anticipated impact of the partnership includes the development of early scientific and regulatory guidelines for high-quality continuous manufacturing processes. The partnership will also create a foundation for successful product development, tech transfer, and drug application filings and will guide the post tech transfer verification of active pharmaceutical ingredients, intermediates, and dosage forms. As a result, the partnership will provide validation of U.S.-based advanced manufacturing processes to increase local production capacity and reduce the over-dependance on exports from just a few countries. “Through this partnership with USP, the leading independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, Phlow will help assure the essential medicines being developed and manufactured meet the highest quality standards. We hope the USP and Phlow program will serve as a catalyst for industry change as we work together to apply pioneering flow chemistry, advanced manufacturing and novel analytical approaches to these critical medicines,” said Edwards. “We believe the essential medicines we make at Phlow today, in partnership with USP, will save countless American lives tomorrow.” About Phlow Phlow Corp. is a trailblazing, essential medicines impact company that is reimagining essential medicines from start to finish through the use of flow chemistry. Everything Phlow does is designed to promote access to affordable, high-quality essential medicines for all Americans. Phlow provides a solution to the broken essential medicines supply chain by offering a resilient end-to-end solution that is U.S.-based, comprehensive, and fully integrated. With the support of a world-class team, strategic partners, and established relationships at the policy, regulatory, and federal levels, Phlow will manufacture active pharmaceutical ingredients (API) and finished pharmaceutical products, domestically for essential medicines critical to the Nation’s healthcare. Through the use of continuous-flow technology and green chemistry, Phlow is able to reduce costs and waste, improve quality and yield, and offer a more environmentally friendly alternative to batch manufacturing. About USP USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP’s standards are used in the U.S. and other countries to ensure the quality of thousands of products including cardiovascular, oncology, endocrine and antibiotic drugs. Through its standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide. For more information, visit usp.org. View source version on businesswire.com:https://www.businesswire.com/news/home/20210222005551/en/ CONTACT: Phlow Contact Grace Catlett:[email protected] Mobile: 516-318-8563USP Contact Anne Bell:[email protected] Office: +1-301-998-6785 Mobile: +1-240-701-3242 KEYWORD: VIRGINIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: HEALTH CHEMICALS/PLASTICS MANUFACTURING RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Phlow Corp. Copyright Business Wire 2021. PUB: 02/22/2021 09:30 AM/DISC: 02/22/2021 09:31 AM http://www.businesswire.com/news/home/20210222005551/enCopyright Business Wire 2021. 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Aaron Tveit Is Back! Brush Up On Graceland Before the Season Premiere

first_imgGet ready, Tveitertots—The season two premiere of USA’s Graceland, starring Broadway megahunk Aaron Tveit, is just around the corner. But if you can’t possibly wait until June 11, we’ve got you covered. Check out this new shot of Tveit as FBI agent Mike Warren alongside co-stars Daniel Sunjata, Vanessa Ferlito, Manny Montana, Brandon Jay McLaren and Serinda Swan, then click below for a recap (warning, spoilers!) of the entire first season. In case you missed it, the police drama tells the story of Mike Warren (Tveit…swoon), a rookie FBI agent who is assigned to live with a group of undercover agents in a California beach house named, you guessed it, Graceland. Get ready for season two this summer on USA! Star Files Aaron Tveitcenter_img View Commentslast_img read more

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HapaSC redefines race and ethnicity

first_imgThe social community club, HapaSC, is repurposing the question of race and ethnicity to allow students of mixed ethnicities to define themselves in their own terms.HapaSC is hosting The Hapa Project on Trousdale Parkway from March 31 to April 2 from 11 a.m. to 1 p.m. to open up conversations about stereotypes and foster respectful conversations about race.Students can take pictures and write their own definition of who they are on the picture.Jamie Kwong, communications manager of HapaSC, sees the pictures as a platform for those with a multicultural background to define themselves.“People should be able to define themselves and not have to be asked what they are,” Kwong said.  “It’s important on such a diverse campus to kind of include the third race into all that goes on at USC already.”The Hapa photo book, created by the artist Kip Fulbeck, inspired Aly Tsui, the president of HapaSC, and Elisabeth Gilmore, vice president, to bring the Hapa Project to USC.Fulbeck began the project in 2001 to photograph over 1,200 volunteers throughout the nation who identify as Hapa. HapaSC saw the effect the project had and wanted to replicate that effect at USC.Tsui said that there are many ways to define yourself and there is no right or wrong answer.“When people ask you ‘what are you?’ there are so many ways that you can respond that may or may not be what they’re looking for,” Tsui said.“By doing it in a way like this we’re giving the student the power to find out themselves,” Gilmore said.As a club dedicated to inclusivity, HapaSC was created to connect multiracial students and to create an environment where members can openly discuss what being multiethnic means to them.“I think [the purpose of HapaSC is] having a community like this on campus where those people that kind of fit into this, kind of fit into that, but don’t really fit in to either, can come and have a place to call home,” Kwong said.HapaSC was formed to create a safe space for multicultural students to discuss their experiences.“Friendship is something we really want to focus on because I think the friendship level is where barriers start to get broken down,” Gilmore said. “It’s also about raising awareness for people of how to be more respectful when talking about those types of things, or also acknowledging that it even exists.  I think a lot of people categorize it that they’re so exotic or cool but, it’s still an ‘other’ not an ‘us.’”Each week HapaSC focuses on different ethnic mixes to break down barriers between ethnicities.  The goal is to create a collective consciousness to beat the identity crisis, as students of mixed ethnicities are sometimes pressured to choose between one of their identities.“I think most people that come from a unitary race background don’t necessarily comprehend what it’s like to grow up with two very distinct cultures. It is a really interesting experience growing up because you’re constantly balancing obligations and expectations from two sides of your family or maybe even more than that,” Tsui said.HapaSC serves as a resource for multicultural students to explore their mixed backgrounds and experiences, discuss the growing presence of multicultural people in society and provide service opportunities catered to serving those in the Hapa community.“We want to address a segment of society that is not talked about as much and is not really given the credit it necessarily deserves,” Tsui said.last_img read more

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