Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

Open Access

Timothy Hill

FUJIFILM Diosynth Biotechnologies,

  • Research Article
    Overcome Challenges to Successful Manufacture of Biosimilars through Media and Feed Screening and Cell Culture Process Optimization
    Author(s): Min Zhang and Timothy HillMin Zhang and Timothy Hill

    In the journey of drug development through regulatory approval, product quality attributes of a biosimilar protein must compare within defined limits to those of the innovator product. Unlike small molecule drugs, whose structure can usually be completely defined and entirely reproduced, biologicals are typically more complex and consist of heterogeneous populations not entirely identical to an innovator product. Therefore, biosimilarity is generally demonstrated as having matched product quality attributes, comparable in vitro biological activity, and no clinically meaningful differences between the biosimilar drug and innovator product. The complexity of recombinant protein manufacturing processes, including expression systems (i.e., host cell line, expression vector, cell line development process), cell culture process conditions and related nutrient systems, such as cell culture m.. Read More»
    DOI: 10.4172/1948-593X.1000148

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