RICHMOND, Va.–(BUSINESS WIRE)–Mar 21, 2022–
Phlow Corp., a U.S.-based important medicines public profit firm, at present introduced strategic alliances with each Virginia Commonwealth College’s (VCU) Medicines for All Institute and AMPAC Positive Chemical substances to offer contract steady manufacturing analysis and improvement (R&D) companies for small molecule pharmaceutical merchandise. Along with its strong and rising inside capabilities, Phlow’s community of established, revolutionary, and skilled strategic companions will present top quality, U.S.-based superior manufacturing options for small molecule lively pharmaceutical substances (APIs) and registered beginning supplies (RSMs) throughout all phases of improvement utilizing state-of-the-art applied sciences and distinctive trade insights.
Phlow’s Steady Care™ session is an ideation mannequin that gives differentiated pharmaceutical product R&D companies, together with laboratory companies, route scouting and course of intensification, laboratory proof of idea, and cGMP Kilo & large-scale manufacturing companies. Along with present services and capabilities, Phlow is finishing building of extremely automated manufacturing services and a bench scale R&D laboratory facility which shall be positioned adjoining to our companions, VCU’s Medicines for All Institute and United States Pharmacopeia (USP).
“We’re thrilled to supply personalized, superior API and RSM analysis and improvement companies to assist different pharmaceutical and biotech firms of their improvement of medicines for People by utilizing stream chemistry and superior manufacturing to catalyze constructive change,” mentioned Eric Edwards, M.D., Ph.D., co-founder, president, and CEO of Phlow. “Along with our companions, it’s Phlow’s purpose to offer worthwhile insights and state-of-the-art processes to different firms in help of delivering top quality, bettering yields, lowering prices, and sustaining the environment within the pharmaceutical trade.”
Along with Phlow’s alliances with VCU’s Medicines for All, AMPAC Positive Chemical substances, and USP, Dr. Malcolm Berry has signed an unique settlement to hitch Phlow’s R&D Crew as a Senior Guide. Dr. Malcom Berry is a world-renowned chief within the discipline of steady processing for small molecules, whose work contains the event of the world’s first multistage steady manufacturing platform, in addition to the lab-based know-how and a workflow for growing steady API processes. In his new function, Dr. Berry shall be utilizing his community and experience on steady manufacturing to allow peer-to-peer collaboration and the event of personalized options.
“Phlow is making a platform that’s distinctive and differentiated within the trade,” mentioned Dr. Malcolm Berry, Senior Guide at Phlow. “From firsthand expertise I do know that working constantly will allow the administration of high quality in actual time and thru the beautiful management of response parameters carry a few discount in manufacturing variance, which is nice information for sufferers.”
VCU’s Medicines for All Institute and AMPAC Positive Chemical substances have been working intently with Phlow since Could 2020 in help of Phlow’s contract with the U.S. authorities to develop APIs utilizing superior and revolutionary processes. Below the brand new agreements, VCU’s Medicines for All Institute, a trailblazer in stream chemistry and different steady superior manufacturing processes, will present analysis and improvement help to Phlow as a most well-liked strategic accomplice for sure small molecule pharmaceutical merchandise. AMPAC Positive Chemical substances, a world chief and customized producer of APIs, will present scale up and business contract superior manufacturing companies, together with steady, to Phlow’s analysis and improvement shoppers.
“By increasing our present partnership with Phlow to service the business sector, we’re creating a singular ecosystem between trade and academia that brings one of the best minds in superior pharmaceutical improvement and manufacturing collectively to resolve an issue the place there’s an unmet want,” mentioned Frank Gupton, Ph.D., co-founder of Phlow, chair of Virginia Commonwealth College’s Division of Chemical and Life Science Engineering and CEO of the Medicines for All Institute. “Circulate chemistry is an revolutionary, low-cost manufacturing platform that we have to introduce to different pharmaceutical firms within the U.S.”
“We’re excited to proceed working with Phlow, VCU’s Medicines for All Institute and our different companions within the improvement of pharmaceutical merchandise right here within the U.S.,” mentioned Jeffrey Butler, PhD, President of AMPAC Positive Chemical substances. “We’re pleased with what we’re doing in Virginia with this transformational strategic alliance and are persevering with to make the Virginia Gateway area dwelling to an revolutionary, end-to-end, superior manufacturing campus.”
Below an settlement introduced in February 2021, USP, the main unbiased, scientific nonprofit group targeted on constructing belief within the provide of secure, high quality medicines, is constructing a brand new laboratory co-located with the R&D laboratories at Phlow and VCU’s Medicines for All Institute that may develop check strategies and requirements for steady manufacturing. This work will help product improvement, tech switch, and drug software filings utilizing steady manufacturing to foster wider adoption of steady manufacturing by generic-drug and different pharmaceutical producers. The anticipated influence of the alliance contains the event of early scientific pointers for high-quality steady manufacturing processes.
“Pharmaceutical Steady Manufacturing (PCM) poses a number of benefits over conventional batch manufacturing, particularly throughout provide disruptions. These embrace the provision and use of real-time information to speed up manufacturing scale-up and assist enhance medication high quality, enabling extra environment friendly and nimble manufacturing of important medicines and strengthening the general provide chain,” mentioned Ronald T. Piervincenzi, Ph.D., CEO of USP. “As well as, we hope that USP’s work with Phlow will assist pave the best way for the pharmaceutical trade to use steady manufacturing extra broadly for the generic medicines so many sufferers rely on.”
By means of a public-private partnership with the U.S. Authorities, Phlow has demonstrated proof of idea that its novel steady platform is revolutionizing small molecule API improvement. Particularly, Phlow has delivered an important medication API to the U.S. Authorities and efficiently transferred a number of further important APIs to manufacturing for scale up. In 2021, Phlow grew to become a part of the Biomedical Superior Analysis and Growth Authority (BARDA), a part of the workplace of Assistant Secretary for Preparedness and Response (ASPR) on the U.S. Division of Well being and Human Companies (HHS) Contract Growth and Manufacturing Group Community, established to offer home API functionality for important medicines and medical countermeasures. Moreover, Phlow acquired the HHS, Workplace of Small and Deprived Enterprise Utilization (OSDBU), Small Enterprise Prime Contractor of the Yr Award in 2021 for excelling in contract efficiency. Phlow is proud to have been accepted into the FDA Rising Expertise Program for the event and steady manufacturing of APIs.
Collectively, Phlow and the U.S. Authorities are securing the nation’s provide of important medicines and medical countermeasures by leveraging steady stream and superior manufacturing applied sciences. Below this historic partnership, Phlow is setting up the infrastructure and performing the R&D to create a resilient, U.S.-based, end-to-end important medication provide chain. Recognizing the significance of long-term sustainability, and in step with Phlow’s Industrial Sustainability Plan submitted as part of the U.S. Authorities contract award, Phlow is dedicated to turning into self-reliant and maximizing the federal government’s funding. The availability of revolutionary steady manufacturing R&D companies for small molecule pharmaceutical product improvement within the business sector is a vital step in direction of delivering on Phlow’s dedication.
About Phlow TM
Phlow Corp. is a U.S. -based revolutionary important medicines influence firm that’s reimagining the important medication provide chain by innovation in how these medicines are manufactured. Based in 2020, Phlow is dedicated to securing the nation with a predictable and steady home provide of important medicines. Phlow is working to ascertain a resilient end-to-end resolution that’s U.S.-based, complete, and totally built-in so no affected person visits a hospital to search out out that the medication they want just isn’t out there. With the help of an distinctive staff, skilled strategic companions, and established relationships on the coverage, regulatory, and federal ranges, Phlow will manufacture APIs and completed pharmaceutical merchandise domestically for important medicines important to the way forward for healthcare. Utilizing state-of-the-art inexperienced chemistry, steady stream know-how, and different superior manufacturing processes, Phlow is ready to cut back prices and waste, enhance high quality and yield, and supply a extra environmentally pleasant various to batch manufacturing. For extra data, go to www.phlow-usa.com.
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CONTACT: Grace Catlett
KEYWORD: UNITED STATES NORTH AMERICA VIRGINIA
INDUSTRY KEYWORD: MANUFACTURING OTHER MANUFACTURING HOSPITALS HEALTH PHARMACEUTICAL
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PUB: 03/21/2022 09:00 AM/DISC: 03/21/2022 09:02 AM