September 11th 2025
Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.
EXO Biologics and ExoXpert Reach Two Critical Milestones that Advance Exosomes
December 3rd 2024EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.
Contamination Control Strategies for Cell and Gene Therapy Facilities at INTERPHEX 2024
April 22nd 2024At 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.
Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers
February 28th 2024Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
Gritgen Therapeutics Launches Commercial GMP Facility in China
October 11th 2023The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
Rentschler Biopharma ATMP Facility Receives MHRA Approval
September 13th 2023Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.