Manufacturing, Cell Therapies

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.

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.

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.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

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.

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A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb.

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

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.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

Activation and expansion are essential for success in both autologous and allogeneic therapies.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

Revolutionary therapies restructure pharmaceutical manufacturing.

There are positive indications for future growth.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.