Manufacturing, Gene Therapies

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

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.

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.

The new protein-based HDR enhancer aims to improve CRISPR precision for advancing cell and gene therapy development workflows.

This collaboration between Andelyn Biosciences and Tern Therapeutics moves the gene therapy TTX-381 closer to approval for treating vision loss linked to CLN2 Batten disease.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

The industry is diversifying pipelines from traditional small-molecule drugs to embrace complex and exciting new modalities.

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

Having completed its €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has driven the growth of Slovenia’s workforce.

Jason C. Foster, CEO and executive director of Ori Biotech, discusses the milestone achievement in commercial-scale CGT manufacturing with the company’s IRO platform.

Prior to this announcement, Rentschler announced in September 2024 it would be launching an expanded service offering at its advanced therapies site in Stevenage, UK, which is now being shut down.

Under the partnership, the companies will combine fully automated and digitalized technologies aimed at reducing CGT manufacturing timelines to 2.5 days.

The collaboration will combine Cytiva’s CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.