A consensus introduction to serum replacements and serum-free media for cellular therapies
| Autor: | Ohad Karnieli, Oryan Makler Friedner, Julie G. Allickson, Nan Zhang, Sunghoon Jung, David Fiorentini, Eytan Abraham, Shannon S. Eaker, tan Kah Yong, Allan Chan, Sarah Griffiths, Amy K. Wehn, Steve Oh |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Serum Cancer Research Consensus media_common.quotation_subject Immunology Cell Culture Techniques Cell- and Tissue-Based Therapy Audit Process validation Culture Media Serum-Free 03 medical and health sciences 0302 clinical medicine Immunology and Allergy Medicine Humans Quality (business) Genetics (clinical) media_common Transplantation business.industry Investigational New Drug Reproducibility of Results Mesenchymal Stem Cells Cell Biology Xeno free Biotechnology Culture Media Clinical trial 030104 developmental biology Oncology Risk analysis (engineering) 030220 oncology & carcinogenesis business Quality assurance Serum free media |
| Zdroj: | Cytotherapy. 19(2) |
| ISSN: | 1477-2566 |
| Popis: | The cell therapy industry is a fast-growing industry targeted toward a myriad of clinical indications. As the cell therapy industry matures and clinical trials hit their pivotal Phase 3 studies, there will be a significant need for scale-up, process validation, and critical raw material quality assurance. Part of the well discussed challenges of upscaling manufacturing processes there is a less discussed issue relating to the availability of raw materials in the needed quality and quantities. The FDA recently noted that over 80% of the 66 investigational new drug (IND) applications for mesenchymal stem cell (MSC) products analyzed described the use of FBS during manufacturing. Accumulated data from the past years show an acceleration in serum consumption by at least 10%-15% annually, which suggests that the global demand for serum may soon exceed the supply. Ongoing concerns of safety issues due to risks of various pathogen contaminations, as well as issues related to the aforementioned serum variability that can affect final product reproducibility, are strong motivators to search for serum substitutes or serum-free media. it is important to note that there are no accepted definitions for most of these terms which leads to misleading's and misunderstandings, where the same term might be defined differently by different vendors, manufacturer, and users. It is the drug developer's responsibility to clarify what the supplied labels mean and to identify the correct questions and audits to ensure quality. The paper reviews the available serum replacements, main components, basic strategies for replacement of serum and suggests definitions. |
| Databáze: | OpenAIRE |
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