China
Africa
Explore chapters and articles related to this topic
EMA-approved biosimilars
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Standard heparin is known to cause adverse reactions called immunogenic responses, such as heparin-induced thrombocytopenia (HIT). LMWH is made from standard heparin but is associated with a lower rate of HIT than standard heparin. The FDA expects sponsors of generic enoxaparin products to demonstrate that their manufactured versions do not have any higher risk of these or other dangerous reactions than Lovenox. Although conducting immunogenicity testing for this product can be an extensive and time-consuming process for a manufacturer, all manufacturers of generic enoxaparin are expected to do this as part of the application process. These studies evaluated impurities using physiochemical and biological assays.
Cloning, expression, and characterization of a novel heparinase I from Bacteroides eggerthii
Published in Preparative Biochemistry & Biotechnology, 2020
Cai-Yun Liu, Wen-Bin Su, Li-Bin Guo, Ye-Wang Zhang
As one of the most widely used bacterial polysaccharide lyase, heparinase I (Hep I, EC 4.2.2.7) is capable of degrading heparin and heparan sulfate at specific 1→4 linkages between hexosamines and uronic acids via a β-elimination mechanism.[1] It has some important medical applications including structure analysis of heparin, detection and removal of heparin contaminants[2,3] and the regional heparinization of human blood.[4,5] In addition, heparinase also has been applied in inhibiting the invasion and metastasis of tumor cells.[6–8] In the pharmaceutical industry, Hep I can be used to degrade unfractionated heparin into low molecular weight heparin (LMWH) which is the derivative produced in the enzymatic or chemical degradational process of heparin. LMWH has a similar antithrombotic ability with heparin but lower anticoagulant ability, so it is considered as an ideal anticoagulant drug to the crude heparin in anticoagulant therapy and shows several advantages over ungraded heparin, such as improved pharmacokinetics, better bioavailability and higher safety in clinical applications.[9–11]