Strict Quality Control Recombinant Serum Albumin HSA White To Light Beige Lyophilized Powder

Strict Quality Control Recombinant Serum Albumin HSA White To Light Beige Lyophilized Powder

Quick detail

1. Appearance: Off-white to light beige lyophilized powder.
2. PH: 6.4-7.4
3. Purity: more than 99% as determined by SDS-PAGE and HPLC analysis.
4. Host cell DNA residues content: less than 0.5ng/g protein
5. Host cell protein residues content: less than 5μg/g protein.
6. Sterility test: sterile
7. The results of abnormal toxicity: conforms to standard

Description

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

OsrHSA, manufactured in a GMP compliance facility with rigorous quality control procedures, performs superior batch-to-batch consistency. The purity is more than 99% and endotoxin is less than 0.01EU/mg.

The stability study includes acceleration stability test and long term stability test. The results indicated that OsrHSA has equivalent stability with pHSA. The current data supports the stability of OsrHSA could be more than 4 years at 2~8℃.

The Specification of OsrHSA

Healthgen Biotech referred to CP (2010) and other recombinant HSA manufactories quality standard and worked out the most restrictive standard of OsrHSA. Healthgen Biotech Biotech innovated and developed two unique items, host cell protein and host cell DNA. The test methods also were reviewed by National Institutes for Food and Drug Control.

Healthgen Biotech 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. 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.

Analytic instruments in QC are listed as below

Supplemental Description

Healthgen Biotech has strong technical force and advanced and complete protein expression and purification technology development and large-scale production facilities. Self-developed rice endosperm cell expression platform (OryzHiExp), which is domestic initiative and the international leader, has such advantages: high expression level, safety, scale-up easily, simple production process and environmental protection etc. After 10 years of unremitting efforts, Healthgen Biotech has established recombinant protein expression and purification technology platform to customize recombinant protein or peptide expression and purification process service for pharmaceuticals, health products, scientific research and industrial reagents. Using the OryzHiExp platform, Healthgen Biotech has achievements in developing and commercializing a series of medium ingredients, including recombinant human serum albumin(OsrHSA), recombinant α-1 antitrypsin(OsrhAAT), recombinant human lactoferrin(OsrhLF), recombinant human basic fibroblast growth factor (OsrhbFGF), recombinant human insulin-like growth factor-1 LR3(rhIGF-1 LR3) , recombinant human epidermal growth factor(rhEGF) and recombinant human fibronectin(OsrhFN), which can provide a full set of solutions for animal component free cell culture medium.