How can the industry bridge the gap between cell and gene therapy innovation and reliable large-scale manufacturing?

Animal testing in drug development is facing growing pressure as scientists and regulators adopt more human-relevant alternatives. Despite decades of reliance on animal studies, more than 90% of drugs that pass preclinical testing still fail in human trials. Advances in biotechnology, particularly human muscle models grown from real tissue, offer a promising alternative by more accurately mimicking human physiology

Donated human cells are the starting point for most cell and gene therapies. Before accepting a vial, bag or tissue sample, cell and gene therapy developers should ask three questions: is donor consent fit for purpose; was the right testing performed; and can chain of custody and chain of identity be reconstructed end to end?

As regulatory agencies encourage the adoption of new approach methodologies, pharmaceutical developers are increasingly exploring human induced pluripotent stem cell-derived models to improve translational predictivity. Successfully integrating these systems into drug development pipelines requires robust validation, a strong quality infrastructure and clear context-of-use frameworks

Analytical measurement in drug development spans multiple attributes, from concentration and binding to quality, impurities and function. Aligning these measurements with workflow needs is critical for enabling timely and confident decision-making

Can artificial intelligence truly transform drug discovery without equally transforming the biology and data that underpin it?

How is the synthetic design of genetic elements, such as promoters for cell and gene therapies and biologics, improving development and manufacturing?

As scientists continue to explore the vast web of life’s molecular setups, it has become increasingly clear that a singular approach, focusing narrowly on genomics, transcriptomics or proteomics, can no longer encompass the full picture of cellular biology. The integration of multi-omics has emerged as a transformative methodology, combining the study of DNA, RNA and protein layers along with metabolites to illuminate the complexities of life at an unprecedented depth.

Mapping disease cells in tissue is essential, but extracting and analysing them is what advances drug discovery. Spatial cell sorting enables physical isolation of individual cells for comprehensive multi-omics profiling – bridging the gap between tissue visualisation and functional validation

Nanotechnology has unlocked a new generation of hydrogels that can be tuned for specific clinical demands. From degradation kinetics to drug release and mechanical resilience, nanoscale control is transforming hydrogels from passive wound dressings into active, minimally invasive platforms for joint restoration, tissue regeneration and targeted therapeutics

What is single-stranded DNA and why is it a viable viral vector alternative?

How will innovative human-centred in vitro testing strategies contribute to accelerating the delivery of safer and more effective therapies to patients without, or with minimal, use of animal models?