Manufacturing, Cell Therapies

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

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

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

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

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.

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

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

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.

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

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

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.

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.

The objective of the partnership is to automate portions of ScaleReady’s CGT manufacturing workflow by using Cellular Origin’s robotic system for sterile liquid transfer.

mRNA therapeutics are being researched to support the fight against rare diseases, infectious viruses, and cancers.

The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.

Decreasing vein to vein time saves lives.

The combined solutions are currently available on the market.

CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.

In vivo CAR-T gene therapies could resolve challenges faced by autologous and allogeneic treatments.

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

Vibha Jawa, executive director at Bristol Myers Squibb, and Luke Schenck, principal scientist at Merck & Com, discuss cell & gene therapies and co-processed APIs respectively.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.