Biotech Primer Institute
30 STUDENTS ENROLLED

Course Availability: Unlimited views within 72 hours from time of purchase
Course Running Time:
 50 min | Assessment: 30 min
Course Material: Downloadable PDF of all presented slides
Preview Now: Post-Translation Modifications

Biosimilars provides an overview of the science and biomanufacturing technology used to produce biosimilars. The course begins by taking an in-depth look at the connection between therapeutic protein structure and function. Next the course explains which biomanufacturing conditions can alter a biosimilar, causing it to function differently than the reference product. The course ends with some tested approaches to demonstrating biosimilarity that have been acceptable to the FDA and EMA.

Protein Function
At the completion of this section you should be able to:

  • Define the term protein
  • List three examples of a protein
  • Describe three protein functions

Protein Synthesis
At the completion of this section you should be able to:

  • Arrange the steps of protein synthesis into the correct order
  • Label the parts of an amino acid
  • Explain why proteins fold
  • Deduce what happens when a protein folds properly and improperly

Post Translational Modifications
At the completion of this section you should be able to:

  • Define post translational modification
  • List the purposes for post translational modifications
  • Name two types of post translational modifications
  • Point out that both genes and cells influence the type of post translational modification and the degree to which the protein is modified

Biologics
At the completion of this section you should be able to:

  • Define biologics
  • List the functions of therapeutic proteins
  • Compare and contrast small molecule drugs with biologics

Introduction to Biosimilars
At the completion of this section you should be able to:

  • Define biosmiliars
  • Contrast small molecule drug generics with biosimilars
  • Compare the EMA and FDA definitions of biosimilars

The Product Is The Process
At the completion of this section you should be able to:

  • Define biomanufacturing
  • Contrast the manufacturing process for small molecule drug and biologic
  • List the steps used in biomanufacturing in their correct order
  • Paraphrase the goal for each step of the manufacturing process
  • Distinguish between master cell bank and working cell bank
  • Explain how different master cell lines, with the same gene, can produce different proteins
  • Identify where variations can occur between two different production campaigns
  • Itemize key formulation parameters
  • Give examples of where protein stability testing can be implemented

Biosimilars Safety & Regulation
At the completion of this section you should be able to:

  • Define immunogenicity
  • Predict all the outcomes of an immune response to a therapeutic protein
  • Define data exclusivity
  • Explain how companies can gain approval for a biosimilar

Course Reviews

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  1. Biosimilars

    3

    I really enjoyed the material and learned some good things. But the course doesn’t appear “finished” yet….
    1. Slides 76-83 of the Course Material (.pdf) were omitted from the video presentation. This was important material about biomanufacturing and questions from it were on the quiz for “The Product is the Process.”
    2. The last video (“Biosimilars Case Studies”) was merely a 28 second wrap-up and presented no case studies. Also, during the wrap-up, the viewer was directed to click on “Biosimilars Case Study Questions,” but there was no such place to click in the Curriculum list.
    3. When I clicked on “View Certificate” on this page, the resulting page had no certificate formatting, it merely showed username, score and date in the middle of a white page.
    After these issues are resolved, I’d give the course 4 stars.

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