Abstract
Current cell therapy product limitations include the need for in-depth product understanding to ensure product potency, safety and purity. New technologies require development and validation to address issues of production scale-up to meet clinical need; assays are required for process control, validation and release. Prior to clinical realization, an understanding of production processes is required to implement process changes that are essential for process control. Identification of key parameters forms the basis of process tolerances, allowing for validated, adaptive manufacturing processes. This enables greater process control and yield while withstanding regulatory scrutiny. This report summaries key milestones in specifically for ventral midbrain dopaminergic neuroprogenitor differentiation and key translational considerations and recommendations to enable successful, robust and reproducible current cell therapy product-manufacturing.
Highlights
Despite significant research and economic growth in the field of regenerative medicine and cell therapy industries the full potential has not yet been; realized this has in part been retarded by both process and manufacturing stances
Employing quality by design from the outset ensures that process development is data, risk and knowledge driven, ensuring quality cell therapy products (CTPs)
Protocol and process development must be conceived with control strategies in place to ensure that quality target profiles are met every time
Summary
To produce dopamine, signified by expression of tyrosine hydroxylase (TH). the specific cell nuclei are critical, since several DA neuron groups exist, three of which (A8, A9 and A10) are found in the mesencephalon [43]. Chambers et al introduced the important concept of the dual SMAD inhibition approach, which went on to form the basis of future neural differentiation protocols that followed [16,33,50,51,52]. This approach initially induces hESC neural induction, followed by patterning toward ventral mesencephalic fate [37]. The dual SMAD approach inhibits BMP and TGF-β, resulting in feederfuture science group
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