Discuss the best strategy to ensure both structural

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Reference no: EM133249083

Assignment:

Analytical characterization of the proteins is critical for biosimilar products. Using any two of the suggested articles, please discuss the best strategy to ensure both structural and functional comparison between the original and its biosimilar. You might consider any protein type in general, or focus on some specific type, i.e. monoclonal antibodies. You may substitute one of the articles by a recent publication that describes an approach you find particularly helpful. Do not forget to reference your sources at the end of the post.

1. Based on what you learned from this module and from the papers, name and very briefly define any five of the analytical techniques used for product comparability.

2. Identify 3 main challenges, that in your opinion, present the biggest obstacles for ensuring identity between the original product and a biosimilar.

3. Make your list in the order of complexity of the method and describe what these methods tell us about the property of the product. Make sure you address the challenges names in part 2.

4. The 5 methods should specifically address different aspects of protein structure/function in order to provide the most complete picture.

Reference no: EM133249083

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