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Increases in efficiencies, flexibility, scalability, and sustainability are impacting adoption.
Innovation in this space depends on strategizing for GMP compliance and market access.
Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.
This article explores a grouping strategy for therapeutic peptides incorporating theoretical and experimental methodology and results to define a practical and scientifically justified cleaning procedure.
A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.
May 03, 2024
Mariana’s portfolio of radioligand therapies will strengthen Novartis’ radioligand therapy pipeline.
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.
Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.
May 02, 2024
Key areas to invest include manufacturing process improvements, quality management, and AI.
Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.
May 01, 2024
The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.
April 30, 2024
Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.
April 26, 2024
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.
The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.
Contract manufacturer SK pharmteco will manufacture as well as conduct testing and release of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer.
April 25, 2024
The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.
April 24, 2024
GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.