Hyogo Medical University-launched venture company
Domestic Bovine Platelet Lysate
NeoSERA
NeoSERA® , bovine-derived cell culture serum, is a 100% domestically produced bovine platelet lysate for cell culture that was developed as a raw material for pharmaceuticals, regenerative medicine products, and meets the Ministry of Health, Labor, and Welfare's Standards for Biological Raw Materials.
NeoSERA® achieves superior proliferation in mesenchymal stem cells and fibroblasts compared to media supplemented with 10% fetal bovine serum, which is the commonly used culture method .
Cell culture serum NeoSERA
Raw materials
NeoSERA® is produced in Japan, which has been recognized by the World Organisation for Animal Health (OIE) as a country with a "negligible BSE risk , " the highest level of safety assessment for bovine spongiform encephalopathy (BSE).
The raw material is platelet lysate collected periodically from adult cattle under 36 months of age, in accordance with the EU regulations on adult cattle donor serum (EMA/410/01rev.3).
Pharmaceuticals, regenerative medicine, and other products
NeoSERA® was developed from the beginning with consideration of its compatibility with pharmaceutical and regenerative medicine products. Unlike fetal bovine serum, NeoSERA® is manufactured from blood collected from adult cows managed by our company that have been regularly checked for health by veterinarians, realizing complete traceability. After dispensing into bottles, it is irradiated with gamma rays of 30 kGy or more for sterilization, including virus inactivation, in accordance with the US USDA regulation 9CFR§113.450 and the European EMEA regulation EMEA/CVMP/743/00 (virus clearance test has been conducted). In this way, NeoSERA® is a completely new, safe, high-quality serum for cell culture made in Japan that meets the regulations of the Standards for Biological Raw Materials (Ministry of Health, Labor and Welfare Notification No. 375, September 26, 2014) (Certificate of Eligibility for Regenerative Medicine Products, etc., obtained from the Pharmaceuticals and Medical Devices Agency).
Cell proliferation
NeoSERA® is made primarily from adult bovine platelet lysate, and compared to conventional fetal bovine serum, it exhibits equal or higher cell proliferation, particularly in adherent cells such as mesenchymal stem cells and fibroblasts (Patent No. 6212723, US-11085023-B2, AU2016356125, NZ757903). The high cell proliferation of NeoSERA® not only shortens the culture period, but also reduces costs by reducing the frequency of medium replacement for cell culture in the manufacturing process of pharmaceuticals and regenerative medicine products.
Quality Control
All lots of NeoSERA® undergo quality inspections, including the following items, and we provide an "inspection certificate" stating the quality inspection results. In particular, the endotoxin level is extremely low compared to fetal bovine serum, because it is produced in a nearly closed system from blood collected from a small number of healthy adult cows.
・Virus testing (Bovine virus diarrhea: BVD, Bovine herpesvirus-1: IBR, Bovine parainfluenza-3: PI3)
- Endotoxin concentration (<1.0 EU/ml)
・Mycoplasma negative test
・Sterility test
・General biochemical test