Cell Therapy News Archives

2 08, 2022

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing
Gallery

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing

webmaster2025-10-06T21:48:30+00:00

Effort to address challenges to the manufacturing scale-up of cell-based therapies follows release of Project A-Gene for gene therapy in 2021 The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) today released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case [...]

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturingwebmaster2025-10-06T21:48:30+00:00

12 07, 2022

New method combines a T-cell “barcode” with single-cell RNA sequencing to enhance CAR T–cell therapy
Gallery

New method combines a T-cell “barcode” with single-cell RNA sequencing to enhance CAR T–cell therapy

webmaster2025-10-06T21:48:25+00:00

Scientists at St. Jude Children’s Research Hospital have developed a method that may be able to improve CAR T-cell therapies by identifying the early cells that become effective at killing cancer. St. Jude Children’s Research Hospital scientists have demonstrated that the long-term performance of cancer-killing chimeric antigen receptor (CAR) T cells can, in some cases, be predicted [...]

New method combines a T-cell “barcode” with single-cell RNA sequencing to enhance CAR T–cell therapywebmaster2025-10-06T21:48:25+00:00

4 05, 2022

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients
Gallery

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients

webmaster2025-10-06T21:48:31+00:00

Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patientswebmaster2025-10-06T21:48:31+00:00

5 02, 2021

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic
Gallery

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic

webmaster2025-10-06T21:50:16+00:00

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. Cellular therapy products include cellular immunotherapies, cancer vaccines, [...]

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemicwebmaster2025-10-06T21:50:16+00:00

Characterization and immunogenicity analysis of glutathi- one S-transferase from Otodectes cynotis

Interpreting immunogenicity in oncology clinical trials

Aug 18-21 The BioProcessing Summit – 2025

Quaternized Chitosan-Coated Nano-MOFs as Antigen Nanocarriers with Enhanced Stability and Immunogenicity

Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seq

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release