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

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

doi:10.1007/978-981-16-7589-8_3

Cited by 3 publications

(2 citation statements)

References 39 publications

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“…In the European Union (EU), the European Medicines Agency (EMA) harmonizes bioprocessing activities and coordinates compliance with Good Manufacturing Practices (GMPs) [47]. Specifically, the EudraLex, Volume 4-Good Manufacturing Practice (GMP) guidelines uphold the rigorous standards of Quality Management with regard to the development, production, and oversight of drug products in the pharmaceutical industry of the EU [48].…”

Section: Regulations In the European Union (Eu)mentioning

confidence: 99%

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

et al. 2023

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The advent of bioprocessing has revolutionized the biomanufacturing industry, leading to the rise of biotherapeutics derived from biologic products such as chimeric antigen receptor (CAR) T-cells used for targeted cancer treatment and the Vero cell line for the production of viral vectors and vaccines. Despite these promising developments, most biologic products are characterized by fragile macromolecular structures that are heterogenous with a purity profile that varies with each batch making them susceptible to microorganism contamination. Regulatory oversight of biologic products is imperative to ensure adherence to good manufacturing practices and compliance with quality management systems. Current quality assurance protocols during production include monoclonality during cell line development, real-time monitoring of process parameters, flow cytometry for microbial monitoring, polymerase chain reaction, and immunoassay techniques to amplify DNA sequences related to bacterial or biological contaminants. FDA guidance recommends the implementation of process analytical technology within biomanufacturing production to measure critical quality parameters, which includes screening for potential biological contamination. Future advancements in bioprocess monitoring and control should capitalize on providing cheap, real-time, and sensitive detection. Biosensors, mass spectrometry, and polymerase chain reaction present robust, rapid, and real-time capabilities for multiplexed detection of contaminant analytes and have shown promise in meeting these needs. This review discusses the main biological contaminants of bioprocesses, European Union and FDA regulatory guidelines for monitoring and control within biologics production, existing methods and their limitations, and future advancements for biological contamination detection.

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Section: Regulations In the European Union (Eu)mentioning

confidence: 99%

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

et al. 2023

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“…To ensure that MSCs are consistently produced and controlled according to high quality standards, the good manufacturing practice (GMP) should be employed to produce clinical-grade stem cell products [1,[10][11][12]. In this way, the company INDEBIOC has a security 2 laboratory to isolate, expand and cryopreserve MSCs.…”

Section: Laboratory Characteristics Of Indebioc For Manufacturing Dpscsmentioning

confidence: 99%

Biology, Preclinical and Clinical Uses of Mesenchymal Dental Pulp Stem Cells

Carlos López Noriega,

Franklin Silverstein,

Mariana Suárez Galván

et al. 2023

Recent Update on Mesenchymal Stem Cells

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Dental pulp is a feasible source of stem cells that could be differentiated into osteoblast providing a therapeutic approach, which contribute to bone regeneration. Furthermore, as dental pulp stem cells originate from the neural crest, they have significant potential in regenerating neural tissues. To isolate dental pulp stem cells, it is not necessary to undergo an additional surgical procedure, they can be obtained from teeth that need to be extracted for specific reasons or naturally shed in children. Dental pulp stem cells have an expansive and clonogenic potential by culturing them in a high-security laboratory. As dental pulp stem cells do not express the Major Histocompatibility Complex, these cells can be used trough a universal donor in several clinical procedures. In this chapter, we present evidence about the role and the applications of DPSCs to regenerate bone as well as in clinic cases to treat neurological affections.

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Quality management overview for the production of a tissue-engineered human skin substitute in Malaysia

Seet,

Mat Afandi,

Ishak

et al. 2023

Stem Cell Res Ther

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Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting materials, including tissue samples, culture media, reagents, and consumables must be verified and tested to confirm their safety, potency, and sterility. The final products should also undergo a QC testing series to guarantee product safety, efficacy, and overall quality. The aseptic techniques of cleanroom operators and the environmental conditions of the facility are also important, as they directly influence the manufacturing of good-quality products. Hence, personnel training and environmental monitoring are necessary to maintain GMP compliance. Furthermore, risk management implementation is another important aspect of QA/QC, as it is used to identify and determine the risk level and to perform risk assessments when necessary. Moreover, procedures for non-conformance reporting should be established to identify, investigate, and correct deviations that occur during manufacturing. This paper provides insight and an overview of the QA/QC aspect during MyDerm® manufacturing in a GMP-compliant facility in the Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia.

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

Cited by 3 publications

References 39 publications

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

Biology, Preclinical and Clinical Uses of Mesenchymal Dental Pulp Stem Cells

Quality management overview for the production of a tissue-engineered human skin substitute in Malaysia

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