Excipient Grade Recombinant Human Albumin Liquid rHSA Recombinant Products 70024-90-7

Excipient grade recombinant human albumin liquid

Healthgen Biotechnology established a rice endosperm specific expression technical platform-Oryz^HiExp to highly express recombinant HSA. After more than decade efforts, a recombinant human albumin derived from rice (OsrHSA) has obtained the Drug Master Files (DMF) number(No. 029648) from US Food and Drug Administration (FDA) in 2015, which showed that the excipient grade OsrHSA has good safety and would provide an alternative approach to largely produce pharmaceuticals with cost-effective approach. It is a milestone event in plant molecular pharming.

Healthgen Biotech recombinant human albumin (OsrHSA) has excellent batch consistency. Using self-pollination rice as the bioreactor to express the rHSA, with the world's advanced facility and top production proceeding, Healthgen Biotech produces the high purity and quality OsrHSA, which can ensure the excellent consistency of OsrHSA from different batches.

The OsrHSA displayed similar in vitro and in vivo immunogencity as plasma HSA.

• Double-cross immunoprecipitation experiments between OsrHSA or pHSA and antiserum against pHSA or OsrHSA showed that both OsrHSA and pHSA bound completely to antiserum against OsrHSA or pHSA.
• In ELISA tests, polyclonal antibodies against pHSA reacted equally with OsrHSA.
• Anti-OsrHSA serum neutralized by pHSA or OsrHSA gave a negative response compared with the saline control in the passive cutaneous anaphylaxis (PCA).
• In the human peripheral blood mononuclear cells (PBMCs) model, OsrHSA does not have any drug-related immunotoxic effects and induces the same level of cytokines.

Healthgen Biotec has a professional quality control department, in which 50% of them have master's degree or higher. There are 14 employees in the quality department, 9 of them are in QA and 5 are in QA. All of them have rich experience in analysis research or quality inspection. Half of them have graduated diploma. Every year there are more than 50 training courses, which cover GMP, SOP, specification, hygiene, QA, QC issues, etc. We strictly control the quality of our products to ensure that all products into the market will be in line with quality standards.