Development of a novel, safe, easily standardized, and cost-effective cell growth supplement for diverse cell culture applications - growth supplements in cell culture are essential for providing…

The National Institute of General Medical Sciences awarded $422,285 to Cell Reprogramming & Therapeutics LLC on September 1, 2026, under the Biomedical Research and Research Training program (CFDA 93.859) to develop a novel, safe, easily standardized, and cost-effective cell growth supplement for diverse cell culture applications.

The recipient will address limitations of fetal bovine serum (FBS) and human platelet lysate (HPL) as cell culture supplements by producing an HPL-like supplement derived from megakaryoblastic leukemia cells. The approach uses the MEG-01 cell line, which can be cost-effectively expanded and induced into mature megakaryocytes and platelets through valproic acid treatment. Platelets and mature megakaryocytes will be lysed using the freeze-thaw method and assessed for mitogenic activity on mesenchymal stem cell growth. The resulting supplement would offer consistent composition and pathogen-free characteristics while avoiding the ethical concerns, zoonotic disease risks, and batch-to-batch variability associated with FBS and the production and scalability challenges of traditional HPL.

Performance will occur in Wauwatosa, Wisconsin. The award period runs September 1, 2026, through August 31, 2027. This is a Project Grant, the assistance type typically used for time-limited, results-oriented research investigations.

Development of a novel, safe, easily standardized, and cost-effective cell growth supplement for diverse cell culture applications - growth supplements in cell culture are essential for providing the necessary nutrients, growth factors, and hormones that support cell proliferation and growth. These supplements help maintain cell viability and ensure proper cellular functions during in vitro cultivation. Fetal bovine serum (FBS) has been the traditional standard due to its rich nutrient composition, but its use poses challenges such as ethical concerns, zoonotic disease risks, and batch-to-batch variability. Defined media offer an alternative with a controlled composition, but they are often more expensive and can lack the synergistic factors that serum provides. Human platelet lysate (HPL) has emerged as a promising alternative, particularly for human cell cultures, but issues related to its production, including disease transmission risks and scalability, remain significant. Recent studies have demonstrated the successful production of human platelets from adult stem cells, embryonic stem cells (escs), induced pluripotent stem cells (ipscs), and immortalized cell lines. This progress suggests that HPL could be derived from these platelets, providing a consistent and pathogen-free product. However, producing human platelets at clinically relevant scales and in a cost-effective manner remains a significant challenge. To address these issues, we recently tested the hypothesis that HPL-like supplement could be produced from megakaryoblastic leukemia cells. To this end, we utilized the MEG-01 cell line, which can be cost effectively expanded and induced into mature megakaryocytes and platelets by valproic acid. Through this approach generated platelets and mature megakaryocytes were lysed using the freeze-thaw method and then assessed for their mitogenic activity on mesenchymal stem cells (mscs) growth. Results showed that the lysate of these cells mixture, which we will henceforth refer to as human mature megakaryocytes and platelets lysate (hmpl), promoted the proliferation of mscs. The overarching goal of this proposal is to develop a cell growth supplement competitive with existing growth supplements, such as FBS and HPL, in terms of ease of production, safety, standardization, cost- effectiveness, scalability, bioavailability, reproducibility, compatibility, and regulatory compliance. To achieve this goal, the following studies are planned for phase i and, if successful, for phase II. The objective of phase i studies is to demonstrate that hmpl, at concentrations of 0.5-15%, exhibits a similar cell proliferation-promoting ability for mscs as 10% FBS or 5% donor blood-pooled HPL (specific aim 1) and that mscs expanded with hmpl retain their ability to differentiate into various cell lineages (specific aim 2). If successful, phase II studies will focus on the large-scale production of hmpl and testing its mitogenic activity on various stem cells. IT will also refine production processes, ensure quality control, develop usage documentation, and achieve necessary regulatory certifications. A commercially compatible product emerging from phase i/II studies is a cell growth supplement suitable for both research and clinical applications. This product has the potential to capture a significant share of the combined FBS and HPL market, which was valued at approximately $3.56 billion in 2023.