ACCESS Newswire
23 Jan 2023, 12:35 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 [email protected] or visit www.rns.com.
SOURCE: Hemogenyx Pharmaceuticals PLC
Get a daily dose of Pittsburgh Star 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 Pittsburgh Star.
More Information]LONDON, U.K.: A World Health Organization (WHO) expert group investigating the origins of the COVID-19 pandemic released its final...
Philadelphia Mayor Cherelle Parker's Housing Opportunities Made Easy initiative, which was included in the city budget passed June...
Washington DC [US], June 29 (ANI): Fans of iconic singer-songwriter Paul Simon were left disappointed after the artist cancelled his...
WASHINGTON, 7th June, 2025 (WAM) -- The United States recorded 122 new measles cases this week, with only four reported in Texas. Health...
WASHINGTON, 27th May, 2025 (WAM) -- Two people were killed and nine others, including three teenagers, injured in a shooting at Philadelphia's...
(Washington, DC) - The budget reconciliation bill passed by the United States Senate today would extend tax cuts that disproportionately...
ISTANBUL/PARIS/BRUSSELS: As searing temperatures blanket much of Europe, wildfires are erupting and evacuation orders are being issued...
VENICE, Italy: Over the weekend, hundreds of protesters marched through the narrow streets of Venice to voice their opposition to billionaire...
PARIS, France: France is taking stronger steps to reduce smoking. A new health rule announced on Saturday will soon ban smoking in...
WASHINGTON, DC - U.S. President Donald Trump on Tuesday claimed Elon Musk's success has been built on government subsidies. Without...
EVERGLADES, Florida: Over the weekend, a diverse coalition of environmental activists, Native American leaders, and residents gathered...
BEIJING, China: China's national soccer team may struggle to stir excitement, but its humanoid robots are drawing cheers — and not...