Sawston

Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility

Retrieved on: 
Monday, March 20, 2023
Linda, GMP, MIA, Biotechnology, OTCQB, Medication, Northwest Biotherapeutics, Standard, First, CDMO, SOP, Advent, Standard operating procedure, Knowledge, Medicines and Healthcare products Regulatory Agency, Commercial, MHRA, Pharmaceutical industry, Vaccine, Sawston

BETHESDA, Md., March 20, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, and Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly announce that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K.

Key Points: 
  • All of this work was carried out by Advent BioServices under contract with NW Bio.
  • Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally.
  • The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape.
  • We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license."

Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility

Retrieved on: 
Monday, March 20, 2023
Linda, GMP, MIA, Biotechnology, OTCQB, Medication, Northwest Biotherapeutics, Standard, First, CDMO, SOP, Advent, Standard operating procedure, Knowledge, Medicines and Healthcare products Regulatory Agency, Commercial, MHRA, Pharmaceutical industry, Vaccine, Sawston

BETHESDA, Md., March 20, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, and Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly announce that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K.

Key Points: 
  • All of this work was carried out by Advent BioServices under contract with NW Bio.
  • Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally.
  • The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape.
  • We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license."

Northwest Biotherapeutics Announces Positive Votes At Annual Meeting; Reviews 2022 Progress and Looks Forward to Strong 2023

Retrieved on: 
Friday, January 6, 2023
Linda, Trial master file, OTCQB, Biotechnology, Annual general meeting, PIP, Northwest Biotherapeutics, Certificate, R, The Meeting, Annual Meetings of the International Monetary Fund and the World Bank Group, Patient, Q & A, Consultant, JAMA Oncology, The, New Year, Documentation, Q&A, Holding company, Pharmaceutical industry, Financial adviser, Video game console, Sawston

BETHESDA, Md., Jan. 6, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.

Key Points: 
  • There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
  • Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year.
  • Linda Powers, the Company's CEO, commented:  "2022 has been a year of major accomplishments, and we look forward to an even stronger 2023.
  • We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting."

Northwest Biotherapeutics Announces Positive Votes At Annual Meeting; Reviews 2022 Progress and Looks Forward to Strong 2023

Retrieved on: 
Friday, January 6, 2023
Linda, Trial master file, OTCQB, Biotechnology, Annual general meeting, PIP, Northwest Biotherapeutics, Certificate, R, The Meeting, Annual Meetings of the International Monetary Fund and the World Bank Group, Patient, Q & A, Consultant, JAMA Oncology, The, New Year, Documentation, Q&A, Holding company, Pharmaceutical industry, Financial adviser, Video game console, Sawston

BETHESDA, Md., Jan. 6, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.

Key Points: 
  • There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
  • Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year.
  • Linda Powers, the Company's CEO, commented:  "2022 has been a year of major accomplishments, and we look forward to an even stronger 2023.
  • We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting."

Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility

Retrieved on: 
Wednesday, July 6, 2022
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BETHESDA, Md., July 6, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).  The application builds upon the 3 licenses received for the Sawston facility in 2021. 

Key Points: 
  • As reported last year, a further license from MHRA is required specifically for commercial manufacturing of cellular products.
  • Application for a commercial license requires meeting even higher standards.
  • Preparations for this commercial license application have also included successful recruitment of additional highly experienced, senior-level GMP experts and scientists.
  • Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.

Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility

Retrieved on: 
Thursday, February 17, 2022
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BETHESDA, Md., Feb. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK.

Key Points: 
  • BETHESDA, Md., Feb. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK.
  • Under this regulatory program in the UK, the vaccine is identified as ADCV ("Autologous Dendritic Cell Vaccine").
  • Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility.
  • The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.

Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility

Retrieved on: 
Thursday, February 17, 2022
Collection, Patient, University, Tissue, Genta (company), Company, Northwest Biotherapeutics, Medicines and Healthcare products Regulatory Agency, Toxic Substances Control Act of 1976, Public expenditure, OTCQB, Standard operating procedure, SEC, Immunotherapy, Ovarian cancer, Review, Private Securities Litigation Reform Act, HTA, Human Tissue Authority, GMP, Safety, Risk, Technology, Glioblastoma, Cancer, Biotechnology, AP Biology, U.S. Securities and Exchange Commission, Brain, GBM, News, MHRA, Pharmaceutical industry, Sawston

BETHESDA, Md., Feb. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK.

Key Points: 
  • BETHESDA, Md., Feb. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK.
  • Under this regulatory program in the UK, the vaccine is identified as ADCV ("Autologous Dendritic Cell Vaccine").
  • Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility.
  • The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.

Northwest Biotherapeutics Announces MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility

Retrieved on: 
Tuesday, December 21, 2021
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The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London.

Key Points: 
  • The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London.
  • To date, the Company has developed Phase 1A of the facility, comprising approximately 4,400 square feet of the overall 88,345 square feet.
  • This MHRA license is a culmination of intensive preparations that have been underway for much of 2021.
  • This MHRA license follows the license approval by the UK's Human Tissue Authority (HTA) in October.

Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility

Retrieved on: 
Tuesday, March 16, 2021
Sawston

The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.

Key Points: 
  • The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.
  • Third party production of other products will help support the Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility.
  • The capacity for production of other products will also be an important resource for the region.
  • All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.