ACCESSWIRE
23 Jan 2023, 17:05 GMT+10
LONDON, UK / ACCESSWIRE / January 23, 2023 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for deadly blood diseases, is pleased to announce the successful completion of its third Process Qualification ('PQ') run of the end-to-end process for the manufacture of HEMO-CAR-T cells. The process was carried out in the Company's current Good Manufacturing Practice ('cGMP') compliant clean rooms. It is being followed by analytical release tests conducted by the Company required to verify the quality of the manufactured HEMO-CAR-T cells. The HEMO-CAR-T cells will also be tested by a third party to ensure they comply with a set of required quality attributes.
This PQ run is the third of minimum three identical manufacturing runs required for the submission of an Investigational New Drug ('IND') application to the US Food and Drug Administration ('FDA'). The IND is needed to obtain authorization from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Following completion of all tests across all PQ runs, data will be compiled for inclusion in the IND submission pack.
Enquiries:
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.
The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
SOURCE: Hemogenyx Pharmaceuticals PLC
Get a daily dose of Seattle Bulletin news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Seattle Bulletin.
More InformationTOKYO, Japan: Japanese Prime minister Fumio Kishida said this week that it was "now or never" for Japan, one of ...
WASHINGTON D.C.: As part of its efforts to simplify the national COVID-19 vaccine strategy, the US Food and Drug Administration ...
WASHINGTON D.C.: US authorities said this week that a surge in Cubans and Nicaraguans arriving at the US border with ...
OTTAWA, Canada: Canadian Prime Minister Justin Trudeau's Liberal government plans to implement its long-awaited workforce transition bill, the "Just Transition," ...
TOKYO, Japan: The Yomiuri newspaper has reported that Japanese Prime Minister Fumio Kishida is planning to visit Kyiv in February ...
HONOLULU, Hawaii: The casket bearing Abigail Kinoiki Kekaulike Kawananakoa, long considered the last Hawaiian princess, has gone on public viewing ...
BANGKOK, Thailand: Following China's reopening and the end of its strict COVID-19 restrictions, businesses on Thailand's holiday island of Phuket ...
NEW YORK, New York - Recession fears faded on Wall Street Thursday as annualized 4th quarter GDP (gross domestic product) ...
WASHINGTON D.C.: In December 2022, US existing home sales declined to a 12-year low, but lower mortgage rates raised cautious ...
SEOUL, South Korea: Korea Customs Service data released this week showed that South Korean exports for the first 20 days ...
SEATTLE, Washington: Amazon.com's cloud services division, Amazon Web Services (AWS), has announced that it will expand its data centers in ...
NEW YORK, New York - U.S. stocks crumbled on Wednesday as the extended rally on Wall Street came to an ...