title: A consensus introduction to serum replacements and serum-free media for cellular therapies.
abstract: 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.
authors.affiliation: Karnieli Ltd and ATVIO Biotech, Ticon, Israel. Electronic address: Ohad@karnieli.com.
authors.forename: Ohad
authors.initials: O
authors.lastname: Karnieli
authors.affiliation: Pluristem Therapeutics, Matam Park, Haifa, Israel.
authors.forename: Oryan Makler
authors.initials: OM
authors.lastname: Friedner
authors.affiliation: Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
authors.forename: Julie G
authors.initials: JG
authors.lastname: Allickson
authors.affiliation: Hematology Branch, National Heart, Lung, and Blood Institute National Institute of Health, Bethesda, Maryland, USA.
authors.forename: Nan
authors.initials: N
authors.lastname: Zhang
authors.affiliation: Cell Therapy Research & Technology Lonza Walkersville, Walkersville, Maryland, USA.
authors.forename: Sunghoon
authors.initials: S
authors.lastname: Jung
authors.affiliation: Biological Industries Ltd., Beit Haemek, Israel.
authors.forename: David
authors.initials: D
authors.lastname: Fiorentini
authors.affiliation: Cell Therapy Research & Technology Lonza Walkersville, Walkersville, Maryland, USA.
authors.forename: Eytan
authors.initials: E
authors.lastname: Abraham
authors.affiliation: GE Healthcare Cell Therapy Division, Marlborough, Massachusetts, USA.
authors.forename: Shannon S
authors.initials: SS
authors.lastname: Eaker
authors.affiliation: Bioprocessing Technology Institute, Singapore.
authors.forename: Tan Kah
authors.initials: TK
authors.lastname: Yong
authors.affiliation: Bioprocessing Technology Institute, Singapore.
authors.forename: Allan
authors.initials: A
authors.lastname: Chan
authors.affiliation: Stimlabs, Roswell, Georgia, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Griffiths
authors.affiliation: Irvine Scientific, Santa Ana, California, USA.
authors.forename: Amy K
authors.initials: AK
authors.lastname: Wehn
authors.affiliation: Bioprocessing Technology Institute, Singapore.
authors.forename: Steve
authors.initials: S
authors.lastname: Oh
authors.affiliation: Karnieli Ltd and ATVIO Biotech, Ticon, Israel.
authors.forename: Ohad
authors.initials: O
authors.lastname: Karnieli
mesh_terms: D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards*; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D032921:Consensus; D003470:Culture Media / Q000737:chemistry* / Q000592:standards*; D016895:Culture Media, Serum-Free / Q000592:standards*; D006801:Humans; D059630:Mesenchymal Stem Cells / Q000166:cytology; D015203:Reproducibility of Results; D044967:Serum
chemical_list: D003470:Culture Media; D016895:Culture Media, Serum-Free
keywords: animal component free; cGMP media; cell therapy; defined media; fetal bovine serum; human serum; platelet lysate; serum free; serum replacement; xeno free