Manufacturing, Cell Therapies

BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from this collaboration.

Burgeoning CGT modalities bring promise and challenges.

Sourcing of donor cells, access to fit-for-purpose reagents and manufacturing systems, and scalability are top issues.

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.

Despite many development challenges, stable producer cell lines show real promise.

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.

There are various challenges associated with the development of CAR-T therapies for solid tumor cancers.

Scaling cell therapy production workflows requires the establishment of closed, automated steps.

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.

New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.

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.

Lives are saved when time from vein to vein decreases.

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

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

The combined solutions are currently available on the market.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.