Discuss the best strategy to ensure both structural

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

Questions Cloud

Evaluation processes : As an educator, how do you or would you view these evaluation processes? What can be most useful to faculty from student evaluations?

Domestic and international hrm : Identify one major difference between domestic and international HRM that Victoria's HRM would need to prepare its employees to face in the case.

How would you describe the organisms oxygen : BIOL 012 Austin Community College District how would you describe the organism's oxygen requirement - If you observed thioglycollate broth with growth

Research and development expenses : From the 2018-2021 Financial reports how much did McDonalds spend on

Discuss the best strategy to ensure both structural : Please discuss the best strategy to ensure both structural and functional comparison between the original and its biosimilar.

What did you learn about yourself : Self-Care/Compassion Fatigue - What did you learn about yourself after completing the Life Stress Test and the Compassion Fatigue Self-Test

Safety culture and benchmarking : Addresses key topics related to safety culture and benchmarking. provides a deep reflection on the strengths and weaknesses of each.

Mean and standard deviation of sampling distribution : Suppose that the average weekly earnings for employees in general automotive repair shops is $450, and that the standard deviation for the weekly earnings

Make a presentation for stakeholders : Make a presentation for your stakeholders regarding your funding needs in order to compete for budgetary allowance. In 12-16 slide presentation

User Account

All Pages