Manufacturing

Articles

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products

Jennifer Markarian is a contributing editor for 

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Automation Aids Cell and Gene Therapy Production

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy. 

Frontrunner in Therapies for Complement-Mediated Diseases

The companies hope address the need for efficient collection, cryopreservation, quality control, and logistics capabilities of leukapheresis materials to support various aspects of the cell therapy workflow.

SCTbio and Cyto-care Collaborate to Improve Cell Therapy Cryopreservation 

Feliza Mirasol is the science editor for 

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

Andelyn Biosciences Opens New CGT Manufacturing Headquarters

Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.


Charles River Laboratories Launches LVV Packaging Plasmids

The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.

Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site

Under the new MTA and Option License Agreement, Adcendo can nominate ADCs against two novel ADC targets, according to the press release.

Adcendo and Duality Biologics in License Agreement to Expand ADC Pipeline

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

Vinnova Supports the Formation of Nordic CCRM Hub

uBriGene Biosciences will acquire Mustang Bio’s Worcester, Mass., CGT manufacturing facility in a deal worth up to $11 million, expanding its operations into the US market.

Manufacturing, Cell Therapies