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  September 26, 2016
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SinoBio Biotech

Cailun RD #720
Shanghai 201203
China

Phone: 08621-5079-8028
E-Mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Stock symbol: SNBB
Please notice: This entry hasn't been updated by the submitting company for more than 2 years. It could be possible that this company doesn't longer exists.

Description:

   SinoBio Biotech's purification development group has developed purification processes for a wide variety of recombinant proteins. Many of these process development projects are undertaken in collaboration with the customer's process development and analytical scientists. A wide range of chromatographic operations have been used for the purification of recombinant proteins (e.g. ion exchange, hydrophobic interaction, affinity, ceramic Hydroxyapatite, metal chelate, gel permeation, etc.).

    Scientists in SinoBio Biotech have taken part in 9 protein drugs process development. That is one third of biologics in China protein drug market. In the past three years SinoBio Biotech have established about 400 different proteins manufacture process scale from milligram to tens of gram. About 40 cytokines and tens of enzymes are qualified by well known reagent and cytokine sellers and contract all over the world. Five of them are get into preclinical trials and one of them filed IND.

PROCESS DEVELOPMENT

    Points to consider in developing a biopharmaceutical process include: protein purity, scale-up requirements, yield, practical manufacturability and overall cost.

A typical process development protocol for recombinant protein includes:

1.Optimization of Expression Systems
 
  • choice of vector
  • choice of cell line and clonal selections
2.Optimization of fermentation Conditions
 
  • available media and supplements
  • growth parameters including pH, temperature, O2, etc.
3.Development of a purification SOP
 
  • choice of chromatography steps
  • Endotoxin removal
  • virus inactivation and clearance
4.Confirmed by the customer and technique transfer
 
  • Original records
  • Quality analysis method
  • Quality analysis results
  • Final SOP of the manufacture process with GLP standard
  • Products when required

PRODUCT DEVELOPMENT:

SinoBio Biotech provide flexible services to meet your diverse requirements. Product development service coupled with SinoBio's contract protein manufacture service can provide you materials you needed with minimal cost esp. when customer just need the protein as raw material and don't want set up their own manufacture facilities.

SinoBio Biotech provide serials quality controls such as SDS-PAGE, HPLC, MS, MS/MS, Amino acid sequencing, endotoxin control to ensure the quality of the final products meet your requirements.

A typical product development procedure includes:

1.Discussion with the customers requirements
 
  • amounts of final products
  • quality requirements
  • time lines
2.Development the products by SinoBio's scientists
 
  • choose of proper expression systems
  • fermentation and purification process development.
  • establish quality control method
  • formulation
3.Confirmed by the customer and shipment.
 
  • q.c. methods
  • amounts of the products
  • quality of the products
4.The customer will get.
 
  • the final products
  • quality analysis results
  • final report contains
        publishable manufacture process
        qc method
        formulation of the products

    Please contact us for details about process development and product development by email to info@sinobio.net or call us 8621-5079-8029.


Service Terms
    SinoBio Biotech provide recombinant protein services include:
        Expression with diverse expression systems
            such as e.coli, yeast, insect cells and mammalian cells.
        Manufacture of target protein( Product development)
            OR establish manufacture procedure for the customer (Process development).
        Protein Refolding and Protein modification such as PEGylation
        Protein Analysis
            such as AA sequencing, MS, HPLC, endotoxin test, biological activity assay...

Confidentiality
   
Your confidential sequence to us by mail will be covered. We will sign non-disclosure or confidentiality agreements when necessary.
    A general template for MTA and CFA are available and you may change the terms according to your requirements and discuss it with SinoBio.


Delivery
   
Materials delivered to customers include the following:
    1. Expression e.coli strain in glycerol.
    2. DNA sequence data (When necessary.).
    3. Required final products in conventional buffer.
    4. Manufacture reports, including the major process, interim results, quality control.
    Delivery time:
   
The typical delivery time for shipment is about 4 business days. This may vary depending on where the customer located and accidentally, delayed by custom check.
    The final products will be shipped via fedex. DHL is optional according to the customer's requirements.


Request to the Customers

    1. Tell us your purpose such as products required or process required.
    2. Provide us the requirements of the final products essentially the purity and amount, other quality control requirements are optional with additional charge such as HPLC, AA Sequencing, MS, MS/MS, biological activity, endotoxin control etc. For details please read protein analysis.
    3. A purification service can begin from electronic sequence of your target protein or partially purified products.
    4. The customers need to pay for 50% fees as subscription for the first order.
    5. For more genes to be expressed or complex project, please contact us for a quote.

Correlative Service
    Gene Synthesis
    Polyclonal Antibody Production
    Protein Analysis (HPLC, LAL, AA Sequencing, MS, MS/MS)
    Protein PEGylation
    Protein Refolding
    Activity assay for some of the proteins
    Expression in P.Pichia
    Expression in Insect Cells
    Expression in Mammalian Cells
    Expression in e.coli

Why SinoBio
    Professional: SinoBio Biotech focus on recombinant protein manufacture only, and the focus makes us more professional. All of the group leaders are come from big biopharmaceuticals with more than 10 years experience on protein production. The company are well equipped with Bioengenering fermentor, AKATA, HPLC and we can provide cGMP standard for your production. The fermentation scale is from liters to 500 liters. Final production is scale from milligram to tens of gram.
    Expertise: SinoBio's protein experts have more than 300 different protein purification experience, involved in NINE biologics development, most of them are in market and some of them in clinical trails. They also developed about 40 qualified cytokines and tens of biological enzymes.
    Quality: Diverse quality control method available for your choice such as amino acid sequencing, MS, MS/MS, LAL test, HPLC in addition to conventional SDS-PAGE analysis.
    Speed: Fast turnaround time (~10 days for a basic order)
    Price: Competitive prices as low as 800$
    Confidentiality: Strictly confidential customer's data. SinoBio will sign non-disclosure or confidentiality agreements when needed.


How to order
   
Please download the order form to specify your information, billing information, and project information;
    Please email the completed order form to info@sinobio.net

    Please follow these instructions closely to speed up your ordering process.

    1. SinoBio Biotech adopt a non-disclosure policy to all of our customers. To protect your proprietary information please mail, email (info@sinobio.net) or fax (+8621-5079-8029) your confidentiality agreement to us for sign. If intended, this should be done before any information is released to us. If you don't have your own NDA/confidentiality agreement, you can find ours at here. Feel free to modify it to suit your specific needs.

    2. Call us (+8621-5079-8029) or email us info@sinobio.net, your gene/protein sequence and particular manipulations you wish us to perform. Particularly give clear instructions on the following options: codon optimization vs. no optimization; host organisms; single host vs. multiple host optimization. Total amount of final protein you required, the qualities and QC terms you required.



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Biopharma
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Contract
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- Research
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Last update of this entry: May 17, 2008

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