Humira Drug (biotechnology)

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Part A

-        The name of the drug Humira exemplify ‘HUman Monoclonal Antibody In Rheumatoid Arthritis’ (Medical New Today 2016). It is usually available in vial for injection or for a pen device which patients can inject themselves at home. Humira (adalimumab) is an artificial antibody which was man-made that has anti-TNF monoclonal recombinant immunoglobulin G1 (IgG1) properties (Mease 2007). The antibody binds to TNFalpha to diminish the inflammation caused by it. Thus, lessen the symptoms of the diseases (Medical New Today 2016). The benefits of Humira can be fully utilised by using it with methotrexate or Humira alone. It reduces harm to the patient’s joints and bones so that they can conduct their daily routines in treating rheumatoid arthritis(RA), hidradenitis suppurativa (HS), psoriatic arthritis (PsA) and Ankylosing spondylitis(AS) in adults(FDA 2013). Humira also medicates for adults has moderate to severe Crohn’s disease assisting in clinical remission in patients that shows no effect on other treatments and cure. Treating moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in younger kids 2 years old and above. Humira is taken so that ulcerative colitis(UC) can be controlled albeit other cures are not working effectively. For the patients who are going for phototherapy, Humira injection is taken to ensure that moderate to severe chronic plaque psoriasis(Ps) is restrained. In order to treat non-infectious ultraviolet in adults’ eyes (HUMIRA®(adalimumab) 2016).

-        Humira attach only to TNF to deactivate the uses of TNK biologically by inhibiting the interaction with the p75 and p55 of the surface of the cell in the TNF receptors (Sladden et al 2005). On top of that, Adalimumab adjusts the biological reaction produced by TNF and regulates the changes how molecules adhere in leukocyte migration in the immune system which is VCAM-1, ICAM-1, and  ELAM-1 with an IC50 of 0.1-0.2 nM. Patients will experience a prompt declination in the acute phase reactants of inflammation levels when the levels of erythrocyte sedimentation rate ESR, C-reactive protein(CRP) and serum cytokines (IL-6) subsided. For Crohn’s disease patients, an observation of inflammatory markers in the colon and expression of TNF alpha will decrease gradually (HUMIRA (adalimumab) 2016).

-        To produce the adalimumab, it started with culturing the Chinese Hamster Ovary(CHO) cells.  This is achieved by sub-cloning the spinner flask. When the time comes to be inoculate, the cells are moved to a fermentor and then further seeding. A medium is then put into the culture to raise the volume of the culture to be harvested.

        Fermentation starts until the cell has been fully grown. Purification of adalimumab is conducted through a few chromatography procedures and the conditions must be of nanofiltration for virus inactivation/removal and low pH treatment.

Later, excipients are put together with the active ingredient, adalimumab through diafiltration, filtered sterilely, dispense it aseptically and close in the type 1 pre-sterilised syringes in glass form or vials (EPAR 2016).

-        According to PMLiVE (2016), it all started in 1999 when the clinical trials for adalimumab was discovered as a completely human anti-TNFα antibody with monoclonal properties. In 2001, a clinical trial showed 5/10 of the 271 patients shows 50% improvement in with rheumatoid arthritis. FDA approved of Humira in 2002. Humira reached a milestone in 2005 when sales hit $1 billion (Kempeni 1999). In 2016, Humira’s US patent is expiring  and a new generic biosimilar drug was introduced (Reuters 2016).