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 The latest in cell & gene research, from advanced therapies through to the latest developments in cell & gene research, therapies & manufacturing

Top R&D Stories of 2023

Through captivating articles, insight pieces, and spotlight interviews, we delve into the remarkable innovations, breakthroughs, and scientific marvels that have defined the landscape of research over the past year.
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Cell & Gene Therapy Manufacturing

Metabolic Modelling and Machine Learning Technologies in Cell and Gene Manufacturing

Integrating PAT into metabolic modelling can help optimise the product obtained from cell cultures, augmenting the manufacturing process.
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Cell & Gene Therapy Manufacturing

Cell and Gene Manufacturing Approaches and Winning Strategies for Commercialisation and Scale-Up

With a host of factors to consider in cell and gene manufacture, upscaling is still no small task. However, as industry experience accumulates and new technologies arrive on the market, there are an increasing number of options for developers looking to get their therapeutic on the road to the clinic.
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Gene Therapy Development

CGT Manufacturing: Key Considerations for Implementing AI/ML Approaches

AI/ML approaches are not some miracle ‘one size fits all' fix-all for delays and holdups in CGT manufacture, but the proper implementation of deep learning approaches and data interpretation may help speed up development.
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Cell Therapy Development

Regulation and Policy Interview with Scott Burger, Principal of Advanced Cell and Gene Therapy

Scott Burger, Principal of Advanced Cell and Gene Therapy, discusses some of the recent trends in regulation and policy surrounding cell and gene therapy development.
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Cell & Gene Therapy Manufacturing

AI in Gene Therapy: How Could Machine Learning Approaches Reshape Therapeutic Development?

As more developers bring their cell and gene therapy products to industry regulators, the need to drive cost and process efficiencies is on track to keep growing. Across the board, AI and machine learning approaches have the potential to streamline many aspects of development.
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Cell Therapy Development

CHO Cells and Engineering Cell Line Approaches: Addressing Challenges in Manufacturing

Regulatory approval is, as ever, a crucial factor to bear in mind during the later phases of clinical trials. Regardless of the cell line approach chosen, keeping a consistent process and product output is key for establishing a successful project without it being hamstrung at the final hurdle.
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Cell & Gene Therapy Manufacturing

Industry Insights Into the FDA's Plans for Revised Gene Therapy Approval Approaches

Some additional measures announced include the launch of the Cell and Gene Therapy Access Model, as well as the interpolation of RWE into trials and a potential move away from animal models in validating treatment efficacy.
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Gene Therapy Development

FDA Pursues Accelerated Approval Path Following Cell and Gene Therapy Backlog

The announcement comes with the news that the cell and gene therapy manufacturing market is now worth US$ 19.3 billion, with a compound annual growth rate (CAGR) of 29% between 2022 and 2023.
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Cell Therapy Development

Jemperli Granted FDA Approval in Endometrial Cancer Applications

Following FDA approval for the use of Jemperli in the context of patients with dMMR recurrent or advanced scenarios, the therapeutic's applications are being investigated in registrational enabling studies as monotherapy and as part of combination regimens.
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Cell Therapy Development

Senti Streamline Their CAR-NK Cell Therapy Program to Focus on Acute Myeloid Leukaemia

By dropping down from three to two ongoing cell therapies in clinical development, Senti aims to ensure its current financial reserves last into 2024.
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Gene Therapy Development

Fortunes Brighten for Bluebird Bio as Cash Runway Extended to 2024

After a rocky year, bluebird bio's approval journey for a treatment for sickle cell disease looks to be back on track, with the company generating more funds by selling shares.
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Cell Therapy Development

Funding Boost Announced for Experimental Cancer Medicine Centres

Potential treatments which may benefit from the funding increase include CAR-T cell therapies and checkpoint inhibitors, with the end goal of clinical use in cancer patients.
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