NOVEMBER 2023LIFE SCIENCES REVIEW8Narayana Raos we enter a new era of precision medicine, the rapid emergence and evolution of cell and gene therapy (CGT) has offered hope for the treatment of both rare and common genetic disorders as well as previously incurable life-threatening diseases such as cancer. This fast-paced development is reflected in the rapid growth of the global cell and gene therapy market which reached nearly $4.4 billion in 2020 with a compound annual growth rate (CAGR) of 25.5% over 5 years. Moreover, the rising prevalence of chronic diseases coupled with an aging population is expected to propel the growth of this market to almost $34 billion by 2030. The evolution of cell-based therapeutics has also brought to the forefront an emphasis on biomanufacturing innovations. Development for CGT requires improvements in biomanufacturing efficiency and flexibility in manufacturing. Some of the key biomanufacturing trends that have emerged in the pandemic era include the explosive growth of new modalities and the need for rapid industrialisation. Novel platforms such as cell therapy, gene therapy, and mRNA are complementing more traditional platforms such as mAbs, and as such, researchers are looking at more therapeutic areas such as Alzheimer's disease, Parkinson's disease and Infant Spinal Muscular Atrophy.These sources of research and development, along with the usage of these platforms to support a wide landscape of therapeutic areas, bring about opportunities to collaborate and transform the industry. Digitalisation and rapid adoption of Industry 4.0 technologies will also revolutionize all aspects of biopharma. Challenges Facing the CGT SectorThough accelerated development in the CGT sector is promising, it needs to be accompanied by a fundamental shift in the traditional biomanufacturing model. However, challenges for CGT exist at every level. Scalability and manufacturability remain two closely linked challenges that By Narayana Rao, Vice President of Biopharma, Asia Pacific Middle-East Africa, AvantorACELL AND GENE THERAPY NAVIGATING THE NEXT FRONTIER IN BIOMANUFACTURING the CGT industry faces to fulfil its clinical potential.The specialized biologic material used in CGT makes it imperative that the open systems inherited from the traditional research and development space cannot be applied due to the frequent need for sampling and the associated risk of contamination. There also is a lack in ready-to-use packaged materials as well as GMP availability of raw materials with supply chain reliability and controlled manufacturing.Against this backdrop, how can industry players pinpoint core challenges,and navigate complex paths towards better outcomes? Some specific solutions are outlined below.IN MY OPINION
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