Bioproduction News

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Map, join and drive European activities for Advanced therapy medicinal product development and implementation for patient ans society benefit: JOIN4ATMP

JOIN4ATMPOvercoming hurdles in advanced therapy medicines Date: 1 January 2024 – 31 December 2026 (Ongoing) Coordi…

Cell therapy
Stipulations of cell and gene therapy and the ties to biomanufacturing

Abstract Cell and gene therapy (CGT) products are emerging and innovative biopharmaceuticals that hold promise for treat…

Public Health
Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.

This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical r…

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Cell BioEngines Announces Establishment of New R&D Facility to Further Advance Its Platform and Pipeline of Innovative Cell Therapies

Cell BioEngines, a clinical-stage biotechnology company developing a universal ‘plug-and-play’ allogeneic stem cell …

Cell therapy
Astraveus Announces World First End-to-End Production of CAR-T Cells Using Microfluidic Technology

Astraveus SAS, the Benchtop Cell Factory company, today announces the first ever successful end-to-end production of CAR…

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Cell therapy
Neogap Therapeutics receives EMA’s ATMP classification for its personalised cancer cell therapy

Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company, announces that the European Medicines Agency (EM…

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Gene therapy reverses heart failure in new trials

Failing hearts nearly returned to full function in laboratory pigs after they received an experimental gene therapy. New…

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Synthetic Biology Focused Insights Report 2024-2029 with Competitive Analysis of 38 Vendors

The global synthetic biology market report contains exclusive data on 38 vendors. The market is highly competitive, with…

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FDA-Approved Sickle Cell Therapies From Bluebird Bio And Vertex Join Medicaid Innovation Program

The Biden-Harris administration has announced an initiative to improve access to gene therapies for sickle cell disease …

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FDA Approves Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency

The FDA approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated …

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CAR T-cell therapy produces ‘jaw dropping’ results for deadly pediatric brain tumors

Chimeric antigen receptor T-cell therapy can reduce tumor burden and improve neurologic function for patients with certa…

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Implementing Advanced Manufacturing Technologies for Novel Therapies

Michele Ghinizzini, Senior Vice President, Global Head of Engineering and Maintenance at Sanofi, and a 2024 ISPE Facilit…