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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.
April 17, 2024
ADC manufacturing facilities are requiring more stringent containment requirements as well as advanced analytical detection.
At INTERPHEX 2024, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, explores the impact of QMS on quality maturity.
Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.
The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes.
April 16, 2024
Bill Whitford, Strategic Solutions leader at Arcadis, reviews the progress made in 3D bioprinting toward commercial biologics production at INTERPHEX 2024.
The collaboration will focus on differentiated cancer vaccine candidates in hematological and solid tumor indications to treat unmet medical needs.
This investment will bolster the company’s large-scale cell culture CDMO business at its planned Fujifilm Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina.
April 15, 2024
WMFTS’ new WMArchitect single-use solutions offers standard ready-to-use single-use assemblies as well as customized designs for biopharma fluid management.
April 12, 2024
The collaboration aims to reduce manufacturing time and costs, allowing more access to specialized cancer treatments.
April 10, 2024
In back-to-back deals, Charles River will offer plasmid DNA manufacturing services for a gene therapy under development by Axovia Therapeutics and for a lead candidate being developed by Ship of Theseus.
April 08, 2024
Memel Biotech aims to offer a range of services from discovery through to formulation for preclinical through to late-stage clinical and commercial production of advanced therapies.
April 04, 2024
Lonza has made a deal with Acumen Pharmaceuticals to manufacture sabirnetug, a mAb that will soon be entering Phase II development for treating Alzheimer’s disease.