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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A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

Key areas to invest include manufacturing process improvements, quality management, and AI.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.

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.

The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.

GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.

At INTERPHEX 2024, BioPharm International spoke with Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, about how to effectively conduct sterile powder transfer during the fill/finish step in parenteral drug product manufacturing.

Current trends, such as single-use technologies, presen advantages and new challenges for pumping systems, according to Andreas Frerix, product management director for Quattroflow at PSG Biotech.

As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.

At INTERPHEX 2024, Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, discussed how the advancement of sensor technologies are being shaped by current industry trends.

The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA.

Under the agreement, Bristol Myers Squibb will have access to Cellares’ fully automated cell therapy manufacturing platform, Cell Shuttle, to manufacture select CAR-T cell therapies.

BioPharm International® sat down with Nicole Hunter, Watson-Marlow Fluid Technology Solutions’ head of Global WMArchitect at INTERPHEX 2024, to discuss the impact of single-use technologies on fluid-handling workflows in bioprocessing.

BioPharm International sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies at INTERPHEX 2024 to examine the implementation of Annex 1.

At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.

The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.

At INTERPHEX 2024, Wenyu Zhang, PhD, covered new trends in the aseptic industry and the key factors companies should consider while weighing their options.

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.

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.

WMFTS’ new WMArchitect single-use solutions offers standard ready-to-use single-use assemblies as well as customized designs for biopharma fluid management.