Abstract
Cell and gene therapies (CGTs) are examples of future therapeutics that can be used to cure or alleviate the symptoms of disease, by repairing damaged tissue or reprogramming defective genetic information. However, despite the recent advancements in clinical trial outcomes, the path to wide-scale adoption of CGTs remains challenging, such that the emergence of a "blockbuster" therapy has so far proved elusive. Manufacturing solutions for these therapies require the application of scalable and replicable cell manufacturing techniques, which differ markedly from the existing pharmaceutical incumbent. Attempts to adopt this pharmaceutical model for CGT manufacture have largely proved unsuccessful. The most significant challenges facing CGT manufacturing are process analytical testing and quality control. These procedures would greatly benefit from improved sensory technologies that allow direct measurement of critical quality attributes, such as pH, oxygen, lactate and glucose. In turn, this would make manufacturing more robust, replicable and standardized. In this review, the present-day state and prospects of CGT manufacturing are discussed. In particular, the authors highlight the role of fluorescent optical sensors, focusing on their strengths and weaknesses, for CGT manufacture. The review concludes by discussing how the integration of CGT manufacture and fluorescent optical sensors could augment future bioprocessing approaches.
Highlights
The last four decades have seen enormous strides in our ability to effectively culture mammalian cells, which is an essential requirement for the development of innovative biotechnology.1 Cell culture is the established method for producing proteins, as it permits the production of large, functionally modified and glycosylated macromolecules.2 In addition, cell culture has become essential for the synthesis of viral vectors for gene therapies.3 Application of these important cell and gene therapies (CGTs) has required significant advancement in both manufacturing capacity and sensory bioprocessing technology.4,5While this capacity has proved exceptionally capable for large-scale manufacture of pharmaceuticals and biologics, future Cell and gene therapies (CGTs) and tissue engineered therapies (TETs) are significantly more challenging to manufacture
Despite the recent advancements in clinical trial outcomes, the path to widescale adoption of CGTs remains challenging, such that the emergence of a “blockbuster” therapy has so far proved elusive. Manufacturing solutions for these therapies require the application of scalable and replicable cell manufacturing techniques, which differ markedly from the existing pharmaceutical incumbent. Attempts to adopt this pharmaceutical model for CGT manufacture have largely proved unsuccessful
The authors highlight the role of fluorescent optical sensors, focusing on their strengths and weaknesses, for CGT manufacture
Summary
The last four decades have seen enormous strides in our ability to effectively culture mammalian cells, which is an essential requirement for the development of innovative biotechnology.. Cell culture is the established method for producing proteins, as it permits the production of large, functionally modified and glycosylated macromolecules.. Cell culture has become essential for the synthesis of viral vectors for gene therapies.. Cell culture has become essential for the synthesis of viral vectors for gene therapies.3 Application of these important cell and gene therapies (CGTs) has required significant advancement in both manufacturing capacity and sensory bioprocessing technology.
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