دورية أكاديمية
أعرض في EDS

A GMP-compliant manufacturing method for Wharton's jelly-derived mesenchymal stromal cells.

التفاصيل البيبلوغرافية
العنوان: A GMP-compliant manufacturing method for Wharton's jelly-derived mesenchymal stromal cells.
المؤلفون: Chu W; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Zhang F; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Zeng X; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., He F; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Shang G; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Guo T; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Wang Q; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Wu J; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Li T; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Zhong ZZ; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Liang X; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China., Hu J; Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China. sean.hu@beike.cc., Liu M; National Engineering Research Center of Foundational Technologies for CGT Industry, 518000, Shenzhen, Guangdong, People's Republic of China. liumuyun@nlelpct.com.; Shenzhen Kenuo Medical Laboratory, 518000, Shenzhen, Guangdong, People's Republic of China. liumuyun@nlelpct.com.
المصدر: Stem cell research & therapy [Stem Cell Res Ther] 2024 May 03; Vol. 15 (1), pp. 131. Date of Electronic Publication: 2024 May 03.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101527581 Publication Model: Electronic Cited Medium: Internet ISSN: 1757-6512 (Electronic) Linking ISSN: 17576512 NLM ISO Abbreviation: Stem Cell Res Ther Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central
مواضيع طبية MeSH: Mesenchymal Stem Cells*/cytology , Mesenchymal Stem Cells*/metabolism , Wharton Jelly*/cytology, Humans ; Cell Culture Techniques/methods ; Cell Differentiation ; Cells, Cultured ; Cell Proliferation ; Cell Separation/methods ; Cell Separation/standards
مستخلص: Background: Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) hold great therapeutic potential in regenerative medicine. Therefore, it is crucial to establish a Good Manufacturing Practice (GMP)-compliant methodology for the isolation and culture of WJ-MSCs. Through comprehensive research, encompassing laboratory-scale experiments to pilot-scale studies, we aimed to develop standardized protocols ensuring the high yield and quality of WJ-MSCs manufacturing.
Methods: Firstly, optimization of parameters for the enzymatic digestion method used to isolate WJ-MSCs was conducted. These parameters included enzyme concentrations, digestion times, seeding densities, and culture media. Additionally, a comparative analysis between the explant method and the enzymatic digestion method was performed. Subsequently, the consecutive passaging of WJ-MSCs, specifically up to passage 9, was evaluated using the optimized method. Finally, manufacturing processes were developed and scaled up, starting from laboratory-scale flask-based production and progressing to pilot-scale cell factory-based production. Furthermore, a stability study was carried out to assess the storage and use of drug products (DPs).
Results: The optimal parameters for the enzymatic digestion method were a concentration of 0.4 PZ U/mL Collagenase NB6 and a digestion time of 3 h, resulting in a higher yield of P0 WJ-MSCs. In addition, a positive correlation between the weight of umbilical cord tissue and the quantities of P0 WJ-MSCs has been observed. Evaluation of different concentrations of human platelet lysate revealed that 2% and 5% concentrations resulted in similar levels of cell expansion. Comparative analysis revealed that the enzymatic digestion method exhibited faster outgrowth of WJ-MSCs compared to the explant method during the initial passage. Passages 2 to 5 exhibited higher viability and proliferation ability throughout consecutive passaging. Moreover, scalable manufacturing processes from the laboratory scale to the pilot scale were successfully developed, ensuring the production of high-quality WJ-MSCs. Multiple freeze-thaw cycles of the DPs led to reduced cell viability and viable cell concentration. Subsequent thawing and dilution of the DPs resulted in a significant decrease in both metrics, especially when stored at 20-27 °C.
Conclusion: This study offers valuable insights into optimizing the isolation and culture of WJ-MSCs. Our scalable manufacturing processes facilitate the large-scale production of high-quality WJ-MSCs. These findings contribute to the advancement of WJ-MSCs-based therapies in regenerative medicine.
(© 2024. The Author(s).)
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فهرسة مساهمة: Keywords: Enzymatic digestion; Good manufacturing practice; Mesenchymal stem cells; Scale-up; Stability; Wharton jelly
تواريخ الأحداث: Date Created: 20240503 Date Completed: 20240504 Latest Revision: 20240507
رمز التحديث: 20240507
مُعرف محوري في PubMed: PMC11069138
DOI: 10.1186/s13287-024-03725-0
PMID: 38702793
قاعدة البيانات: MEDLINE
الوصف
تدمد:1757-6512
DOI:10.1186/s13287-024-03725-0