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Current Good Manufacturing Practice (cGMP) Facility and Production of Stem Cell

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Stem Cell Production

Abstract

In the last decade, the advancement of stem cell research as a new therapeutic approach in the field of tissue engineering, regenerative medicine, cell and gene therapy had urged researchers to produce clinical grade cell and tissue products. The process of translation from research to clinical application requires strict control of the product to ensure its quality, safety and efficacy. These clinical grade cell and tissue-based products should be manufactured in a current good manufacturing practice (cGMP) facility that is designed and accredited by the regulatory body for the production of cell and tissue. cGMP is the practice regulations or system that is internationally recognised and enforced by the regulatory agencies, that control the authorisation and licensing of the manufactured products such as pharmaceuticals, food and beverages, cosmetics, medical devices, cell and tissue-based products. The quality management system is the crucial part of cGMP to control the manufacturing process (including critical materials, sample collection, processing, culturing, storage quality control testing and release of the cell therapy products), facility management (including design, environmental control and monitoring, maintenance, equipment, personnel access, cleaning), validation, personnel training, competency and also records. The cGMP facilities for cell and tissue therapy should be designed at a higher standard and following the pharmaceutical manufacturer in order to produce a safe and high-quality product for human use. The facility must be designed in a proper size of cleanroom with different class or grade (Grade A, B, C and D) areas depending on air purity and particles. The environmental control, monitoring and maintenance of the facility is critical to prevent contaminations and determines the operation efficiency. The standard operating procedures (SOP) for all related processes and procedures for the production of cell and tissue-based products should be developed and validated before the products can be manufactured and released for therapeutic use. In this chapter, we will discuss details on the cGMP quality system, facility management, manufacturing of the clinical grade cell and tissue-based products and ethical issues. All activities in the cGMP must be documented and audited regularly to maintain the consistency of the products and follow the standard guideline required by the regulator.

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Authors and Affiliations

  1. Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Wilayah Persekutuan Kuala Lumpur, Malaysia

    Wan Tai Seet, Mohd Asyraf Mat Afandi, Sharen Aini Shamsuddin, Yogeswaran Lokanathan, Min Hwei Ng & Manira Maarof

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  1. Wan Tai Seet
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  2. Mohd Asyraf Mat Afandi
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  3. Sharen Aini Shamsuddin
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  4. Yogeswaran Lokanathan
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  5. Min Hwei Ng
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  6. Manira Maarof
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Correspondence to Manira Maarof .

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Editors and Affiliations

  1. Department of Stem Cell Biology, Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

    Firdos Alam Khan

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Seet, W.T., Mat Afandi, M.A., Shamsuddin, S.A., Lokanathan, Y., Ng, M.H., Maarof, M. (2022). Current Good Manufacturing Practice (cGMP) Facility and Production of Stem Cell. In: Khan, F.A. (eds) Stem Cell Production. Springer, Singapore. https://doi.org/10.1007/978-981-16-7589-8_3

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