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Your source for the latest updates, breakthroughs, and insights in drug development and manufacturing. Explore our featured stories, press releases, and event announcements to stay informed about our innovations and contributions to drug development and manufacturing advancements.

2602, 2025

Avance Biosciences™ Registers with CLIA, Expanding Clinical Trial Testing Capabilities

February 26th, 2025|CLIA Testing, News, Press Release|

Avance Biosciences™ announces CLIA registration, expanding its high-complexity laboratory testing capabilities for clinical trials, regulatory submissions, and companion diagnostics. This milestone strengthens its commitment to high-quality, regulatory-compliant testing solutions that accelerate drug...

2602, 2025

Gene Therapy Restores Vision in Children with AIPL1-Related Retinal Dystrophy

February 26th, 2025|News, Press Release|

A groundbreaking gene therapy using rAAV8.hRKp.AIPL1 has restored vision in 11 children with AIPL1-related retinal dystrophy (LCA4), who were blind at birth. Published in The Lancet, the study shows significant improvements in visual acuity and retinal preservation, supporting expedited approval...

2008, 2024

World’s first gene editing therapy for blood disorder to be available to hundreds of patients in England

August 20th, 2024|Gene & Cell Therapy Testing, Gene Editing, News|

Patients in England with severe beta-thalassaemia will be amongst the first in Europe to benefit from one-time gene therapy exagamglogene autotemcel. Exa-cel is the world’s first CRISPR-based gene therapy and the first gene therapy available in Europe for treating severe beta-thalassaemia...

608, 2024

FDA Approves First T Cell Receptor (TCR) Gene Therapy

August 6th, 2024|Gene & Cell Therapy Testing, Gene Editing, News|

Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma...

3107, 2024

Shortening FDA-Mandated CAR T-Cell Therapy Monitoring Periods Could Improve Access to Treatment in Patients With DLBCL

July 31st, 2024|Gene & Cell Therapy Testing, News|

Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period, according to a recent study...

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