Current Issue : April - June Volume : 2013 Issue Number : 2 Articles : 4 Articles
Patents for several biologic blockbusters will expire in the next few years. The\r\narrival of biosimilars, the biologic equivalent of chemical generics, will have an impact\r\non the current biopharmaceuticals market. Five core capabilities have been identified\r\nas paramount for those companies aiming to enter the biosimilars market: research and\r\ndevelopment, manufacturing, supporting activities, marketing, and lobbying. Understanding\r\nthe importance of each of these capabilities will be key to maximising the value generated\r\nfrom the biologics patent cliff....
Generic version of pharmaceutical is very popular now as its availability at low cost. When innovator drug product is going off patent pharmaceutical companies may file application (ANDA) for the approval of generic version. Generic versions are also available in biopharmaceutical products called biosimilars. European countries (EMA) have already established powerful guideline first. Then after WHO and USFDA came to regulate biosimilars. Recently India has released guideline for approval of biosimilars in August 2012. Basic concepts and principle are same but little difference in scope, reference product, and exclusivity and data requirements. This article will review all that guidelines for approval of biosimilars....
Multiple sclerosis is a disease of the central nervous system, resulting in the\r\ndemyelination of neurons, causing mild to severe symptoms. Several anti-inflammatory\r\ntreatments now play a significant role in ameliorating the disease. Glatiramer acetate (GA)\r\nis a formulation of random polypeptide copolymers for the treatment of relapsing-remitting\r\nMS by limiting the frequency of attacks. While evidence suggests the influence of GA on\r\ninflammatory responses, the targeted molecular mechanisms remain poorly understood.\r\nHere, we review the multiple pharmacological modes-of-actions of glatiramer acetate in\r\ntreatment of multiple sclerosis. We discuss in particular a newly discovered interaction\r\nbetween the leukocyte-expressed integrin M2 (also called Mac-1, complement receptor 3,\r\nor CD11b/CD18) and perspectives on the GA co-polymers as an influence on the function\r\nof the innate immune system....
Cell lines derived from mammalian are dominant systems for the production of recombinant therapeutic\r\nproteins because of their capacity for correct protein folding, assembly and post-translational modification.\r\nIn the search of an efficient method for the production of a recombinant protein using animal cell culture, we\r\ninvestigated the effects of different treatment including fetal calf serum concentration, glycerol and culture\r\ntemperature on a Chinese hamster ovary (CHO) cell line on the production of recombinant human growth\r\nhormone (rhGH) and recombinant Chinese hamster ovary (rCHO) viability. The GH production was\r\nassessed using ELISA and western blotting methods and cell viability was determined by flow cytometry.\r\nThe production of recombinant protein increased by 2-fold when stimulatory chemical such as glycerol was\r\nadded in two stages, first cells were cultured without glycerol for a period of time in order to obtain enough\r\ncell density and then glycerol was added to achieve high specific productivity.. Moreover, glycerol addition\r\nincreased cell viability. Low culture temperature (below 37�ºC) led to enhanced cellular productivity of the\r\nrhGH by 3-fold but decreased cell viability. These findings indicate that quite simple factors such as culture\r\ntemperature and addition of simple chemicals may lead to the improvement of industrial process for the\r\nproduction of recombinant proteins such as rhGH....
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