Stability indicating analytical methods for biopharmaceuticals
Development and manufacture of biopharmaceutical products is a multi-pronged affair that entails several industrial and clinical processes (Burlingham, 2005, p. 112). These processes are indeed very fundamental in the assurance of quality in both the business and the scientific contexts, not to mention the legal provisions of such procedures. In drug manufacturing industries, this is a regulatory and effectual activity with very firm legal jurisprudence (Subramanian, 2012, p 312). In law, it is an obligation of the statutes but in the professional and ethical sense, it is an affirmation of quality and a further extension of research findings into the stability of these products – biopharmaceuticals (Flickinger, 2013, p 110).
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