Nature

Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer

Chimeric antigen receptor (CAR) -T-cell therapies have yielded remarkable results in the treatment of hematological malignancies. Several autologous CAR T-cell products have received marketing ...
BioProcess International

Integrating Quality by Design Principles into Gene-Therapy CMC Programs: Establishing Manufacturing Control and Comparability

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...
Drug Target Review

Automated cell-free protein synthesis platform cuts costs by 95 percent

South Korean researchers have developed an automated, modular cell-free protein synthesis platform that slashes preparation ...
GEN

Elegen and Nutcracker Pilot Cell-Free Manufacturing Process for RNA-Based Personalized Cancer Therapeutics

Elegen and Nutcracker Therapeutics launched a pilot program to demonstrate what they label the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer ...
Medical Xpress

Rapid iron flux test could help improve cartilage repair through cell therapy

Researchers from the Critical Analytics for Manufacturing Personalized Medicine (CAMP), an interdisciplinary research group (IRG) of Singapore-MIT Alliance for Research and Technology (SMART), in ...
Business Wire

Cellares’ Cell Shuttle™ Receives FDA Advanced Manufacturing Technology (AMT) Designation for Automated Cell Therapy Manufacturing

The AMT designation gives Cellares’ clients using the Cell Shuttle priority review with the FDA leading to accelerated regulatory filings SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the ...