Healthgen Biotechnology established a rice endosperm specific expression technical platform-OryzHiExp to highly express recombinant HSA. After more than decade efforts, a recombinant human serum albumin derived from rice (OsrHSA) has been approved by CFDA for clinical trial in China. It is a milestone event in plant molecular pharming. If the trials using rice-seed bioreactor are successful, it will provide an alternative approach to largely produce pharmaceuticals with cost-effective approach. Furthermore, as soon as OsrHSA will be verified to be safe in human beings, it will open light for plant molecular pharming and alleviate the apply shortage of HSA in China, even in the world.
The OsrHSA has gained the approval of the clinical trial from National Medical Products Administration (NMPA), which means will provides cost-effective and non-immunogenic HSA suitable for large dosages used in treatments soon.
Healthgen recombinant human serum 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 to extract and purify the OsrHSA, Healthgen can ensure the excellent consistency of rHSA from different batches.
The OsrHSA displayed similar in vitro and in vivo immunogencity as plasma HSA.
Double-cross immunoprecipitation experiments between rHSA or pHSA and antiserum against pHSA or rHSA showed that both rHSA and pHSA bound completely to antiserum against rHSA or pHSA.
In ELISA tests, polyclonal antibodies against pHSA reacted equally with rHSA.
Anti-OsrHSA serum neutralized by pHSA or rHSA gave a negative response compared with the saline control in the passive cutaneous anaphylaxis (PCA).
In the human peripheral blood mononuclear cells (PBMCs) model, rHSA does not have any drug-related immunotoxic effects and induces the same level of cytokines.
Healthgen 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.