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

المؤلفون المشاركون

Galvez-Martin, Patricia
Sabata, Roger
Verges, Josep
Zugaza, José L.
Ruiz, Adolfina
Clares, Beatriz

المصدر

Stem Cells International

العدد

المجلد 2016، العدد 2016 (31 ديسمبر/كانون الأول 2015)، ص ص. 1-14، 14ص.

الناشر

Hindawi Publishing Corporation

تاريخ النشر

2016-11-24

دولة النشر

مصر

عدد الصفحات

14

الملخص EN

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.

نمط استشهاد جمعية علماء النفس الأمريكية (APA)

Galvez-Martin, Patricia& Sabata, Roger& Verges, Josep& Zugaza, José L.& Ruiz, Adolfina& Clares, Beatriz. 2016. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International،Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1117477

نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)

Galvez-Martin, Patricia…[et al.]. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International Vol. 2016, no. 2016 (2015), pp.1-14.
https://search.emarefa.net/detail/BIM-1117477

نمط استشهاد الجمعية الطبية الأمريكية (AMA)

Galvez-Martin, Patricia& Sabata, Roger& Verges, Josep& Zugaza, José L.& Ruiz, Adolfina& Clares, Beatriz. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International. 2016. Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1117477

نوع البيانات

مقالات

لغة النص

الإنجليزية

الملاحظات

Includes bibliographical references

رقم السجل

BIM-1117477