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Wuhan Healthgen Biotechnology Corp.
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Strict quality control Recombinant Serum Albumin Light Beige Lyophilized Powder

Wuhan Healthgen Biotechnology Corp.
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Strict quality control Recombinant Serum Albumin Light Beige Lyophilized Powder

Brand Name : Oryzogen
Model Number : HY100M1
Certification : ISO 9001 certificate
Place of Origin : China
MOQ : Negotiation
Price : Negotiation
Payment Terms : T/T
Supply Ability : 1000kg
Delivery Time : 3~5 days
Packaging Details : 1g/vial 10g/vial 50g/vial
Source : Rice Grain (Oryza Sativa)
Purity : Greater than 99%
Physical Appearance : Off-White to light beige lyophilized powder
Endotoxin : Less than 0.25EU/ug
Package size : 1g/vial, 10g/vial, 50g/vial and 100g/vial
Production Type : Recombinant Protein
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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. Residual DNA content:less than 0.5ng/g

5. Host cell protein residues content: less than 0.5μg/g protein.

6. Sterility test: negative

7. The results of abnormal toxicity check should meet the standard.


Description

Healthgen recombinant human serum albumin (rHSA) 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 rHSA, Healthgen can ensure the excellent consistency of rHSA from different batches.

rHSA, 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 0.25EU/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 2 years at 2~8℃.


The Specification of OsrHSA

Test itemSpecification
Identification- western blottingPositive
pH6.4~7.4
PurityNLT 96%
Host cell DNANMT 0.5 ng/g protein
SodiumNMT 160 mmol/L
Host cell proteinNMT 5 μg/g protein
PolymerNMT 1.0%
Octanoate0.140~0.180 mmol/g protein
AluminumNMT 200 μg/L
Ammonium sulfateNMT 0.5 g/L
SterilityConforms to standard
Pyrogen testConforms to standard
Abnormal toxicity testConforms to standard

Healthgen referred to CP (2010) and other recombinant HSA manufactories quality standard and worked out the most restrictive standard of OsrHSA. Healthgen 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 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

EquipmentOrigin
Microplate readerBio-Tek
Osmotic pressure detectorTianjin SMC30C-1
Liquid ChromatographAgilent
Gas ChromatographPE
Kjeldahl apparatusJinan K9840
RT-PCRABI
Karl fischer moisture meterMettler Toledo
Atomic absorption instrumentPE


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 alphar-1 antitrypsin (OsrAAT), recombinant human lactoferrin (OsrLF), recombinant human basic fibroblast growth factor (OsrbFGF), recombinant human insulin-like growth factor-1 (OsrIGF-1) and recombinant human transferring(OsrTF), which can provide a full set of solutions for animal component free cell culture medium.


Product Tags:

recombinant human albumin

      

humans serum albumin

      
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