Manufacturing, Gene Therapies

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

Synthesis of DNA via cell-free methods has many benefits versus fermentation.

EXO 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.

TrakCel's OCELLOS, an IT platform, has been selected to orchestrate the administration of five out of seven autologous or matched allogenic cell therapy products approved or expected to be approved in 2024.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

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

Cellevate's nanofiber microcarriers are the first on the market for use in manufacturing viral vectors used in gene therapy production, according to the company.

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

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.

Under the long-term supply agreement, Lonza will 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.

Emerging therapies, such as cell and gene therapies, come with unique challenges that must be planned for in advance.

The latest developments in emerging therapies, including new innovations and collaborative efforts in manufacturing.

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

Rentschler Biopharma now offers a new lentiviral vector manufacturing toolbox at its site in Stevenage, UK.

Under the license agreement, Andelyin Biosciences will expand its AAV Curator Platform by including MyoAAV plasmids developed by Broad Institute of MIT and Harvard.

Optimizing AAV vector manufacturing will be necessary to meet anticipated future market demand.

AAV and lentivirus both have pros and cons in their use for specific gene therapy applications.

BioIVT has launched new cleanroom manufacturing space using Germfree’s technology that boosts its cell and gene therapies development capabilities.

Under the expanded agreement, Univercells and University of Pennsylvania will evaluate certain bioreactors for scalable gene therapy production.

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

FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.

CGT manufacturing processes need automation as well as standardization, according to Lonza’s Joe Garrity and Jerry Jiang.

Joe Garrity and Jerry Jiang from Lonza share their insights on the latest trends and challenges for the commercialization of new CGTs.

BioPharm International chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.

CGT Catapult and CATTI have developed aligned training standards for the manufacture of advanced therapies.

Cellular Origins will apply its robotic platform to establish automated CGT manufacturing at CGT Catapult’s manufacturing innovation center in Stevenage, UK.

The Mirus Bio acquisition will boost Merck KGaA’s viral vector manufacturing services.

The organizations plan to combine etherna’s experience in mRNA and lipid-based nanoparticles with UHasselt’s autoimmune research to treat a variety of auto-immune diseases.

Studies conducted by a team at Oxford Biomedica demonstrated that HIC can be used to effectively separate non-deamidated capsids from deamidated capsids.