Wednesday, January 26, 2022 11:29:56 AM
A transcription:
By Mike Scialom mike.scialom@iliffemedia.co.uk
The news that Northwest Biotherapeutics has secured MHRA certification for its manufacturing work in the Sawston Business Park is a triumph for Advent BioServices, which has completed the laboratory facilities to UK regulatory standards on behalf of the US-based clinical stage biotechnology company.
Northwest Biotherapeutics, which is headquartered in Bethesda, Maryland, is focused on the development of personalised cancer vaccines designed to treat a broad range of solid tumour cancers.
Northwest's dendritic cell-based cancer vaccine is a fully personalised immunotherapy treatment that mobilises the entire immune system to fight many types of solid tumour cancers.
Its Sawston R&D team is working on a cancer vaccine for glioblastoma
multiforme, the most aggressive type of brain cancer. Phase III data is expected in the near future. The treatment has been described as a 'major breakthrough in the treatment of glioblastoma, following the publication of blinded interim results in the Journal of Translational Medicine.
Advent BioServices - also based on the plant site at Sawston -began as a cell therapy contract development and manufacturing organisation (CDMO) in 2016. Currently there are 40 staff working on the site, of whom about 40 per cent are scientists. Dr Mike Scott, who joined Advent as COO in April 2019, has overseen the design.
"Advent was contracted to build out the facility in 2019," Mike says. "The warehouse was already at the site, and we're further developing it-it's about 90,000sq feet dedicated to cell therapies, officially referred to as 'advanced therapy medicinal products, or ATMPS. We've built out around one-fifth of the whole building, When fully built out, it will be one of
Europe or North America." The MHRA accreditation allows GMP (clinical grade) manufacturing of medical products to commence in the Sawston facility.
"The MHRA manufacturing approval is connected to the site at Sawston Business Park," Mike says. "and Advent is contracted to put together everything for that licensing, which was granted in mid-December.
"So, from now, advanced cell therapy products can be manufactured in the building."
Mike has impeccable credentials for overseeing the company's development work, having been director of the cellular therapy facility at Cambridge University Hospitals NHS Foundation Trust for more than 20 years before arriving at Advent.
"I really enjoy the job and the challenges," he says of the role. "We now have a state-of-the-art facility here at Sawston in addition to a certificate received last year from the
the largest facilities of its kind in Human Tissue Authority which allows us to process and store cell and tissue for medical purposes. The facilities include GMP clean rooms for the production of human cell products, research and process development laboratories, and a large cryo-storage facility."
He adds: "I came here thinking it would take much longer to obtain our regulatory licences, but my team has worked tirelessly and managed to get it done sooner despite being in the midst of a pandemic and despite serious supply chain difficulties. especially for specialised equipment and materials."
The progress in bringing this. facility together was supported in part by a £1.35m loan from the Cambridgeshire and Peterborough Economic Development Authority for the Phase la buildout and equipment. Northwest currently has a contracted team of over 40 on the site, which could expand to 300 when the project is fully completed.
Recent NWBO News
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM
VPR Brands (VPRB) Reports First Quarter 2024 Financial Results • VPRB • May 17, 2024 8:04 AM