セルトリズマブ ペゴル（遺伝子組換え） 化学特性,用途語,生産方法
説明
Certolizumab pegol, a tumor necrosis factor α(TNF-α) blocker, was
launched for the treatment of moderate-to-severe Crohn’s
disease. It is specifically indicated for reducing signs and symptoms and
maintaining clinical response in adult patients who have had an
inadequate response to conventional therapy. Certolizumab pegol is
the third anti-TNF-α biologic to be marketed for this indication behind
infliximab (Remicade) and adalimumab (Humira). Certolizumab
pegol is a recombinant, humanized antibody Fab’ fragment linked to
approximately 40 kDa polyethylene glycol (PEG). The Fab’ fragment is
composed of a light chain with 214 amino acids and a heavy chain with
229 amino acids. It is manufactured in E.coli and is subsequently
subjected to purification and conjugation to PEG, to generate certolizumab pegol. The addition of PEG moiety significantly enhances the
plasma half-life of the antibody, allowing for less frequent dosing. Certolizumab pegol neutralizes both soluble and membrane-associated forms of human TNF-a. It binds to human TNF-a with slightly higher affinity (KD 0.09 nM) than infliximab (KD 0.23 nM) and adalimumab (KD 0.16 nM). In addition, in cellular assays, certolizumab pegol is more potent in preventing TNF-a-induced killing of L929 fibroblasts than infliximab and adalimumab (IC50 0.35 ng/mL versus 5 and 6 ng/mL, 592 Shridhar Hegde and Michelle Schmidt respectively).
使用
Treatment of rheumatoid
arthritis and inflammatory bowel disease.
副作用
The most common adverse reactions with certolizumab were upper respiratory infections (20%), urinary tract infections (7%), and anthralgias (6%). TNF-a blockers as a class have been linked to increased risk of opportunistic infections and malignancy. Tuberculosis, invasive fungal infections, and other serious infections have occurred in patients receiving certolizumab pegol, and the drug label contains a black-box warning of the risk.
セルトリズマブ ペゴル（遺伝子組換え） 上流と下流の製品情報
原材料
準備製品