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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 07, 2024
This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.
May 06, 2024
Under a partnership, ProPharm and PBL have launched the Cell Factory Box, an enclosed and fully automated cell factory manufacturing device.
The collaboration will target solid tumors using Poseida’s allogeneic CAR-T platform to develop convertibleCAR programs.
Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.
May 05, 2024
Digital transformation is allowing for better handling, analysis, and protection of vast data collection.
May 04, 2024
A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
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A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.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The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.