Manufacturing

Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, Regeneron spoke about the use of bispecific antibodies to retarget AAV specificity.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

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.

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.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.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

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

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.

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.

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.

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.

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.