Description

The overarching goal for this course is a general understanding of the Product Lifecycle and how it is managed. Participants will gain an appreciation of the different stages of the Product Lifecycle, especially how decisions made early on impact later stages. Participants will apply knowledge gained to analyze situations and discuss the pros and cons. Participants will understand their role in Product Lifecycle Management.
**NOTE** This course will begin with an introduction to antibodies (their structure and function), characterization of the qualities of antibodies, and consider how monoclonal antibodies spread through a human, are degraded, and how that impacts their design. We will also talk extensively about Critical Quality Attributes and Critical Process Parameters. All of these topics are introduced and supported with resources; however, if this level of biological and technological detail is not relevant for you this may not be the correct course for you.
 

Objectives

1.  Illustrate the timeline, order, and overlap of the Pharmaceutical Lifecycle.
   1. Define Product and Process.
   2. Describe the relationship between Product and Process.
   3. Articulate the importance of Knowledge Management.
   4. Recognize the role Quality plays throughout the Product Lifecycle.
2. Describe what an antibody is, what is does, how antibody structure affects function and what characteristics affect how long antibodies persist in the body.
   1. Define the terminology listed below and use the terms correctly.
   2. Explain what type of antibody Vedolizumab is and its mechanism of action.
   3. Describe the basic processes Takeda uses for manufacture of Vedolizumab. Transfection, Cell Culture, Cell Clarification, Downstream Purification, Analytical Technology
   4. Identify CPP for Vedolizumab manufacturing and CQA of Vedolizumab.
3. Describe the basic scientific considerations of Pharmaceutical Development.
   1. Apply the principles of a Target Product Profile to steps of Pharmaceutical Development.
   2. Explain the role of Quality by Design during Pharmaceutical Development.
   3. Connect the Product Lifecycle with the Process Lifecycle during Pharmaceutical Development
   4. Explain how choices during Pharmaceutical Development affect later PLM stages.
4. Define Drug Substance and Drug Product and explain their differences and how they relate.
   1. Explain the role of Quality by Design and Risk Assessment in Process Development.
   2. Identify major considerations for mAb Process Development. 
   3. Explain the concept of Design Space and its role during the Product Lifecycle.
   4. Describe the role of Process Validation and Analytical Method Validation.
5. Explain the Goals of Process Validation
   1. Define the purpose of: - Process Design - Process Qualification - Continued Process Verification
   2. Describe the purpose of Analytical Method Validation
6. Explain the purpose of the IND and generally what information is required.
   1. Describe the basic differences and purpose of Phase I, II, III Clinical Trials.
   2. Explain the purpose of the BLA and CTD and generally what information is required.
   3. Connect the preceding goals to what is present in the TPP and data collected during Pharmaceutical Development.
7. Define Technology Transfer, its purpose, and general uses.
   1. Explain the Key Elements of Technology Transfer and generally what they encompass.
   2. Connect the information in the Technology Transfer to the information gathered during Pharmaceutical Development
   3. Describe how Technology Transfer connects Pharmaceutical Development to Commercial Manufacturing.
8. Be able to define the Post Approval Change Reporting categories.
   1. Be able to apply the types of changes to be reported to the Reporting Categories.
   2. Make connections between the Post Approval Change process and your role at Takeda Brooklyn Park
9. Identify the complexities of global regulation on the PAC process.
   1. Explain why a MAH may discontinue a product
   2. Explain what an MAH must do to notify regulators of product discontinuation