Manufacturing, Cell Therapies

The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.

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.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

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

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

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.

The biopharma industry is seeking ways to apply cell and gene therapies to mass patient populations.

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

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

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.

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.

Regeneron’s work in CAR-T cell therapy development includes engineering receptor architecture to improve CAR-T cell sensitivity and improve immune response.

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

Under a partnership, ProPharm and PBL have launched the Cell Factory Box, an enclosed and fully automated 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.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.

Under the agreement, Bristol Myers Squibb will have access to Cellares’ fully automated cell therapy manufacturing platform, Cell Shuttle, to manufacture select CAR-T cell therapies.

Memel Biotech aims to offer a range of services from discovery through to formulation for preclinical through to late-stage clinical and commercial production of advanced therapies.

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

Cellares CEO Fabian Gerlinghaus explores advancements in counterflow centrifugal elutriation and electroporation, teasing exciting developments in product testing.

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.