Manufacturing, Gene Therapies

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.

CPC’s MicroCNX ULT Series represents the first aseptic microconnector that can be fitted directly into freeze cassettes for GCT production.

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

The nanofiber microcarriers are the first of their kind for manufacturing viral vectors used in gene therapy production, according to Cellevate.

The two companies are partnering to provide logistics and manufacturing services to biotechnology and pharma companies.

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

The next-generation IRO platform was found to significantly outperform the legacy Prodigy system, showing improvements in cell growth, CAR+ cell yield, and overall efficiency.

The collaboration is designed to combine NanoVation Therapeutics’ lipid nanoparticle technology for RNA delivery to cells outside the liver with Novo Nordisk’s knowledge of cardiometabolic and rare disease R&D.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

With the agreement, Andelyin Biosciences will add MyoAAV plasmids developed by Broad Institute of MIT and Harvard to its AAV Curator Platform.

BioIVT opened new cleanroom manufacturing space, using Germfree’s technology to boost its capabilities for cell and gene therapy development.

Innovative solutions are making personalized cell and gene therapies accessible to all.

Univercells and the University of Pennsylvania are expanding their collaboration to evaluate certain bioreactors with the aim to scale up gene therapy manufacturing.

The acquisition of uniQure’s Lexington, Mass., manufacturing operations will boost Genezen’s late-phase and commercial gene therapy development and manufacturing services.

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

Lonza’s Joe Garrity and Jerry Jiang discuss the latest trends and challenges in commercializing new CGTs.

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

CGT Catapult will implement Cellular Origins' robotic platform in its Stevenage, UK, site to establish automated CGT manufacturing.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

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.

With the launch of a new manufacturing service, Memel Biotech will offer services for discovery through to formulation for advance therapy medicinal products.

Can Cellares deliver on the goal to meet total patient demand for cell therapies globally? CEO Fabian Gerlinghaus discusses.