Advances in gene and cell therapy are transforming how the health sector treats and potentially cures chronic diseases. Gene therapy requires delivering the proper sequence of genes to treat, cure, or prevent a disease or medical disorder of patients who have either a defective or missing gene. As the gene or cell industry evolves, several trends - particularly in manufacturing - are worth watching as they continue to shape this therapy and its wider use.
Traditional therapeutics are often designed to treat a disease with a chronic regimen, in many instances with small molecules easy to manufacture process. However, cell and gene therapies require an innovative, often complex manufacturing process using specialized equipment and highly trained medical personnel that must genetically modify the patients' own cells. Because of that fact, before sanctioning clinical development, regulators often seek developers or sponsors with commercial-grade processes with very high quality standards to ensure patient safety.
For a long time, the application of cell and gene therapies has mainly focused on rare diseases and oncology. However, in recent years, these therapies have been increasingly used in other treatment modalities. Also, the industry has shifted the focus to other common diseases outside of cancer and also ushered in a new era for different biological therapeutics.
Traditional therapeutics are often designed to treat a disease with a chronic regimen, in many instances with small molecules easy to manufacture process. However, cell and gene therapies require an innovative, often complex manufacturing process using specialized equipment and highly trained medical personnel that must genetically modify the patients' own cells. Because of that fact, before sanctioning clinical development, regulators often seek developers or sponsors with commercial-grade processes with very high quality standards to ensure patient safety.
For a long time, the application of cell and gene therapies has mainly focused on rare diseases and oncology. However, in recent years, these therapies have been increasingly used in other treatment modalities. Also, the industry has shifted the focus to other common diseases outside of cancer and also ushered in a new era for different biological therapeutics.
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