Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use

Martín, Patricia Gálvez; González, María Bermejo; Martínez, Adolfina Ruiz; Lara, Visitación Gallardo; Naveros, Beatriz Clarés

doi:10.1016/j.biologicals.2012.06.002

Cited by 20 publications

(16 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although the incidence of mycoplasma infection in the cultures is low [48], in most cases it has a human origin, making staff the major source of contamination, particularly M. orale. Accordingly, staff should receive regular training for the aseptic manipulation of therapeutics [22]. Also, both animal serum products and environment are possible sources of contamination [49].…”

Section: Discussionmentioning

confidence: 99%

“…Throughout the process a qualitative and quantitative environmental analyses of microbiological quality of air and surfaces were carried out; the results were within the standards required by the GMP guidelines as previously described [22].…”

Section: Isolation and Culture Of Mscsmentioning

confidence: 99%

“…Two media were used: Trypcase Soja Agar (TSA; bioMérieux) for detection of bacteria and Sabouraud Dextrose Chloramphenicol (SDC; bioMérieux) for fungi. The plates were incubated for 2 days at 35°C for TSA and 5 days at 22°C for SDC [22].…”

Section: Microbiological Monitoring In Processmentioning

confidence: 99%

See 2 more Smart Citations

Standard Requirement of a Microbiological Quality Control Program for the Manufacture of Human Mesenchymal Stem Cells for Clinical Use

Gálvez

Clares²,

Bermejo³

et al. 2014

Stem Cells and Development

View full text Add to dashboard Cite

The manufacturing of human mesenchymal stem cells (hMSCs) as cell-based products for clinical use should be performed with appropriate controls that ensure its safety and quality. The use of hMSCs in cell therapy has increased considerably in the past few years. In line with this, the assessment and management of contamination risks by microbial agents that could affect the quality of cells and the safety of patients have to be considered. It is necessary to implant a quality control program (QCP) covering the entire procedure of the ex vivo expansion, from the source of cells, starting materials, and reagents, such as intermediate products, to the final cellular medicine. We defined a QCP to detect microbiological contamination during manufacturing of autologous hMSCs for clinical application. The methods used include sterility test, Gram stain, detection of mycoplasma, endotoxin assay, and microbiological monitoring in process according to the European Pharmacopoeia (Ph. Eur.) and each analytical technique was validated in accordance with three different cell cultures. Results showed no microbiological contamination in any phases of the cultures, meeting all the acceptance criteria for sterility test, detection of mycoplasma and endotoxin, and environmental and staff monitoring. Each analytical technique was validated demonstrating the sensitivity, limit of detection, and robustness of the method. The quality and safety of MSCs must be controlled to ensure their final use in patients. The evaluation of the proposed QCP revealed satisfactory results in order to standardize this procedure for clinical use of cells.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Isolation and Culture Of Mscsmentioning

confidence: 99%

See 1 more Smart Citation

Standard Requirement of a Microbiological Quality Control Program for the Manufacture of Human Mesenchymal Stem Cells for Clinical Use

Gálvez

Clares²,

Bermejo³

et al. 2014

Stem Cells and Development

View full text Add to dashboard Cite

show abstract

“…Environmental monitoring is aimed to detect changing trends of microbial counts and microflora growth within the cleanroom [6, 40]. The results of the environmental monitoring provide information about the physical construction of the room, the performance of HVAC system [41], personnel cleanliness, gowning practices, and equipment and cleaning operations [42].…”

Section: Microbiological Testsmentioning

confidence: 99%

“…Contamination of MSCs can cause adverse reactions in patients (e.g., fever, chills, infections, and irreversible septic shock) and even death. Therefore it will be necessary to standardize and validate all procedures and analytical techniques involved in its manufacture by the implementation of quality control programs [6]. An environmental monitoring program must be established in the therapy laboratory.…”

Section: Introductionmentioning

confidence: 99%

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

Gálvez‐Martín

Sabata

Vergés

et al. 2016

Stem Cells International

View full text Add to dashboard Cite

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

show abstract

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

Seet

Afandi

Shamsuddin

et al. 2022

Stem Cell Production

View full text Add to dashboard Cite

Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use

Cited by 20 publications

References 29 publications

Standard Requirement of a Microbiological Quality Control Program for the Manufacture of Human Mesenchymal Stem Cells for Clinical Use

Standard Requirement of a Microbiological Quality Control Program for the Manufacture of Human Mesenchymal Stem Cells for Clinical Use

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

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

Contact Info

Product

Resources

About