Thymosin alpha 1

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Processing Time: 1 Days - 60 Days

Packaging Details: STANDARD EXPORTING PACKAGE

Port: Shanghai / Shenzhen / Qingdao / Ningbo / Other

Payment Terms: L/C , T/T , other

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Basic Information

MF

C129H215N33O55
Place of Origin

Jilin, China (Mainland)
Appearance

white powder
purity

8.0%

Brief description

WHITE POWDER Thymosin alpha 1

Detailed description

Specifications

1. white powder
2. lyophilization
3. used for develops greater immunity from disease
4. manufactured under GMP
5. SPPS

Thymosin α1 (Thymosin alpha1, Tα1), originally separated and purified from Thymosin Fraction 5 (TF5), is an acidic peptide comprised of 28 amino acid residues. It has biological regulatory functions that include: (1) recover the function of T-cell and promote proliferation of the matured T-cell and generation of cell factors and receptors, which enhances immune response to tumor; (2) modify the tumor cell to induce the intense immune response of host; (3) promote the differentiation and maturation of tumor cell to resume the cell from malignant proliferation to normal; (4) alleviate the side-effect from chemotherapy and radiotherapy.

In clinical, Thymosin α1 has been used as monotherapy or as an adjuvant for the treatments of hepatitis B, hepatitis C, tumor, immunocompromised and other diseases.

N-acetyl Thymosin α1 is a synthetic peptide drug and has been marketed in many countries since 1997. Beyel Pharmaceuticals is capable of manufacturing N-acetyl Thymosin α1 under GMP compliance.

Essential information

Molecular formula: C₁₂₉H₂₁₅N₃₃O₅₅

Molecular weight: 3108.3

Amino acid sequence:

Ac-Ser-Asp-Ala-Ala-Val-Asp-Thr-Ser-Ser-Glu-Ile-Thr-Thr-Lys-Asp-Leu-Lys-Glu-Lys-Lys-Glu-Val-Val-Glu-Glu-Ala-Glu-Asn-OH

Quality standard-1: (implement the quality standard on Chinese Pharmacopoeia)

Quality standard-2: (purity is better than that of the standard on Chinese Pharmacopoeia)

1,Appearance: White powder

2,Water content (Karl Fischer) : ≤5%

3,Acetate content (HPLC method): ≤5%

4,Amino acid composition: ±10% theoretical value

5,Purity (by two HPLC methods): ≥98.0%

6,Single impurity (by two HPLC methods): ≤1.0%

7,Total impurity (by two HPLC methods): ≤2%

8,Peptide content (Kjeldahl method): ≥85%

9,Assay (anhydrous, without acetate): 95%-105%

10,Bacterial endotoxins: ≤5EU/mg

Package: plastic bottle (peptide special) or glass vial

Short-term storage: avoid from moisture and light at 2-8 °C

Long-term storage: avoid from moisture and light at -20°C

Period of validity: 2.0 years

Thymosin alpha 1

Company Profile

Established in 2004, our company is located in the High & New Technology Development Zone of Changchun City in Northeast China. Our company is a biopharmaceutical enterprise engaged in the research, development, production and marketing of vaccines, biologics and peptide & chemical drugs.

There are two products of Varicella Vaccines (live) and Human-use Rabies Vaccines (Vero cell) in Chinese market. The sales amount of Varicella Vaccines in 2009 reached RMB220 million and the sales amount of Rabies Vaccines is growing constantly in 2010. A new vaccine being developed in our company against HIV for the prevention of epidemic disease of Aids is in phase II clinical trial in China. Furthermore, a peptide drug for the treatment of diabetes mellitus is on clinical trial and is estimated to be introduced to Chinese market in 2012. In addition, our company has a wide range of projects at different stages in a variety of therapeutic areas and a strong product pipeline, aiming at launching several more vaccines, biologics, peptide and chemical drugs in the coming years.

Since our establishment, our company has been emphasizing building up our cutting-edge technology with the most dedicated and talented scientists and state-of-the-art equipment and facilities. Each year, our company invests a considerable amount of money from the sales turnover in R&D to develop innovative and qualified healthcare products.

About 70 researchers among our 500 staff members are with university education or with postgraduate study in multi-disciplines of chemistry, biology and medicine. Most of them have been working in project R&D and product manufacture in biopharmaceutical industry for many years with adorable experience and expertise. A number of members in the management team and senior consultants have been educated and working in pharmaceutical companies in the USA and Europe. Besides, our company has cooperated with several well-known universities and research institutes in China and in the world to enforce and promote our innovative platform. The long relationship and close dialogues with SFDA (State Food and Drug Administration of China) ensure our products have great development and best fulfill all regulatory requirements in the market.

Changchun BCHT Biotechnology Co. has facilities of laboratories under GLP or GMP management for research, pilot plants for scaling up and factories for product manufacture. The R&D facilities, with an area over 2000sqm and more than 200 sets of instruments, include clear rooms, dark rooms, PCR rooms and laboratories for synthesis, purification, fermentation, analysis, in-vitro tests and animal tests, providing advanced means for our company to develop vaccines and peptide & chemical drugs. The pilot plants, with an area over 3500sqm and more than 300 sets of equipment, allow our company to carry out and promote the promising candidates of products from laboratory to massive production lines in factories. We have three production subsidiaries: BCHT Biopharma for the production of Varicella Vaccines (live), Maifeng Biopharma for the production of Rabies Vaccines and Baiyi Pharma for the production of peptide and chemical drugs in the future, currently under construction and GMP management by FDA for API manufacture.

Noteworthily, Changchun BCHT Biotechnology Co. has an extensive sales network and organization in China for marketing our products.

We sincerely wish to find competitive partners worldwide on technology cooperation and product co-promotion in any possibly creative form, establishing win-win partnerships and achieving bilateral commercial success with customers.

Our mission is as the abbreviation in our company's name - BCHT: "Biotech Creates a Healthy Tomorrow for the mankind".