Videos

At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1. 

Annex 1 Alignment: Addressing Contamination Control and Assessing Risk

Articles

The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes. 

Cytiva Showcases Single-Use Mixing System at INTERPHEX 2024

Feliza Mirasol is the science editor for 

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

Keynote Session Highlights Importance of Process Validation and Data Integrity (INTERPHEX 2024)

The airlock solution for cleanrooms offers contamination controls for a highly controlled environment.

AES Clean Technology Launches CleanLock Module

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

At INTERPHEX, Bill Whitford, Strategic Solutions leader at Arcadis, discusses the progress made in 3D bioprinting toward commercial biologics production.

Bill Whitford of Arcadis Discusses 3D Printing for Biologics (INTERPHEX 2024)

WMFTS has launched WMArchitect, a single-use product line that offers ready-to-use single-use assemblies and custom-designed workflows for biopharma fluid management. 

WMFTS Showcases New Single-Use Solutions Designed to Optimize Fluid Management 

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

FDA Establishes Center for Clinical Trial Innovation

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Charles River has entered into separate agreements with Axovia Therapeutics and Ship of Theseus to offer plasmid DNA manufacturing services for a gene therapy and a lead candidate program, respectively.

News