联系人：李经理
手机：18116171568
邮箱：lgj@theramabs.com
地址：上海浦东新区惠南镇东征路133号
网址：www.Theraprotein.com
Product Name：Ustekinumab |
Introduction: |
This product is the biosimilar of Ustekinumab (815610-63-0), which is a human IgG1κ monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant technology, The biosimilar is produced in a well characterized recombinant cell line and is purified using standard bio-processing technology. The manufacturing process contains steps for the clearance of viruses. It is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. *Statement: this product is used for R&D and IND only, not for clinical and commercial usage before registered in drug registration authority. |
Features and Advantages: |
| NameUstekinumabCAS NO.815610-63-0TypeWhole antibodySourceHumanTargetIL-12 and IL-23CloneMonocloneMolecular Weight148 kDaFormulaC6482H10004N1712O2016S46Antibody FormPurified immunoglobulinPhysical FormSolutionPlace of OriginUSAStorageSealed and stored at -70±15℃, away from light |
Specifications: |
The Ustekinumab is supplied at 2mg/tube, 5mg/tube, 10mg/tube, 20mg/tube as a sterile, clear and colorless, preservative-free solution. |
Quality Assurance： |
(1) We have advanced technology and equipment to satisfy the requirements of GMP. All the raw material purchasing and production quality control are strictly following the ISO9001. (2) We own a group of QCs with rich experience, mainly engaging in testing APIs, intermediates and finished products. Before posting, all of the stuffs must receive professional training and GMP courses. (3) The COA(Certificate of Analysis), MOA(Method of Analysis), SDS(Stability Data Sheet), DMF(Drug Master File) and MSDS(Material Safety Data Sheet) are available. |