rme-2019-0076.pdf (989.95 kB)
From protocol to product: ventral midbrain dopaminergic neuron differentiation for the treatment of Parkinson's disease
journal contribution
posted on 2019-11-18, 13:53 authored by James Kusena, Rob ThomasRob Thomas, Mark McCall, Sammy WilsonSammy WilsonCurrent 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.
Funding
Engineering and Physical Sciences Research Council (grant no. EP/L015072/1)
History
School
- Mechanical, Electrical and Manufacturing Engineering
Published in
Regenerative MedicineVolume
14Issue
11Pages
1057 - 1069Publisher
Future Medicine LtdVersion
- VoR (Version of Record)
Rights holder
© J Kusena, RJ Thomas, MJ McCall and SL WilsonPublisher statement
This work is licensed under the Creative Commons Attribution 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/Acceptance date
2019-10-10Publication date
2019-11-13Copyright date
2019ISSN
1746-0751eISSN
1746-076XPublisher version
Language
- en
Depositor
Dr Sammy Wilson. Deposit date: 15 November 2019Usage metrics
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