Manufacturing, Gene Therapies

AbelZeta Pharma has reclaimed global rights to prizloncabtagene autoleucel from Janssen and secured FDA clearance to begin US trials, positioning the anti-CD20/CD19 bispecific CAR-T for patients who relapse after existing CAR-T therapies.

Genprex moves its diabetes gene therapy toward the clinic, tapping a CGMP CDMO after preclinical models reversed hyperglycemia in mice.

Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.

The European Medicines Agency has granted orphan designation to Atsena Therapeutics' ATSN-101 and ATSN-201, AAV gene therapies for Leber congenital amaurosis 1 and X-linked retinoschisis, as both programs advance toward pivotal Phase 3 trials.

Imunon has reported positive preliminary data from its phase 2 minimal residual disease study of IMNN-001, a DNA-based IL-12 gene immunotherapy, showing a lower MRD-positive rate, higher ctDNA clearance, and more patients reaching no evidence of disease compared to standard chemotherapy alone in frontline advanced ovarian cancer.

MilliporeSigma's Sebastián Arana outlines why flexible, platform-based manufacturing and workforce training are now table stakes for competitive biomanufacturers.

As part of our continuing coverage from the BIO International Convention 2026, Pharmaceutical Executive spoke with Martha Fowler, founder of Steer Bio, about the company's regenerative medicine platform, its lead program for cancer-related lymphedema, and how non-dilutive funding is supporting its path toward first-in-human studies.

Voyager Therapeutics presented six-month GLP toxicology data showing its tau-silencing AAV gene therapy VY1706 was well tolerated and reduced tau protein by up to 75% in key brain regions of non-human primates, with a clinical trial in Alzheimer's disease expected to begin in the second half of 2026.

The FDA has approved a label expansion for Casgevy, the first CRISPR-based gene therapy, lowering the eligible age from 12 to 2 years in sickle cell disease — a move that significantly broadens the potential patient population and marks another milestone in the clinical maturation of CRISPR-based genomic medicine.

Cytiva’s Pierre-Alain Ruffieux discusses standardization, regionalization, talent gaps, and regulatory pathways shaping advanced biomanufacturing’s future ahead of BIO 2026.

Charles River Laboratories’ Dr. Alan K. Smith explains how early commercial planning, modular manufacturing, and AI-driven automation may accelerate scalable manufacturing for cell and gene therapies.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Automated density gradient ultracentrifugation boosts the efficiency of AAV purification.

AI and automation may streamline cell and gene therapy manufacturing by reducing labor demands while improving efficiency and supporting scalable production, says Dr. Alan Smith of Charles River Laboratories.

Dr. Alan Smith of Charles River Laboratories explains why early manufacturing planning and scalable processes are critical to ensure successful commercialization of complex cell and gene therapies as part of his panel discussion at INTERPHEX 2026.

Astellas taps Dyno’s AI-designed AAV capsid to boost skeletal muscle gene delivery, aiming for lower doses and safer next-gen therapies.

The approval introduces a one-time gene therapy for LAD-I that restores immune function and addresses the underlying cause of a life-threatening pediatric disease.

Key 2025 FDA draft and final guidances emphasize the modernization of biotech regulations, acceleration of rare-disease therapies, and streamlining of biosimilar pathways.

Autolomous and Trenchant’s partnership, begun early in 2025, addresses unmet CGT manufacturing needs, including slashing costs and cutting timelines.

Charles River has launched a second cohort to speed CGT innovation with technical guidance and scalable manufacturing support.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

The partnership is aiming to embed digital identification into labware, solving chain-of-identity challenges for individualized cell and gene therapies.

As cell and gene therapy is poised to play a major role in the future of medicine, it’s important to know the basics.

In a session at the Cell and Gene Meeting on the Mesa, Prime Medicine CEO Allan Reine discussed how prime editing offers versatile, safe gene correction, but that delivery to target cells remains a major hurdle.

A panel at the Cell and Gene Meeting on the Mesa discussed how advanced therapy production demands modular platforms, automation, and data governance to drastically improve patient access and affordability.