Overview of Tech Transfer in the Vaccine Industry: Part 1
Learning Objectives:
Upon completion of the course, participants will be able to:
- Explain the types of tech transfer, and the elements involved in a tech transfer.
- Describe key activities for a tech transfer agreement.
- Create a tech transfer plan incorporating relevant process types and defined success outcomes.
- Decide on stakeholders and build a project management team to execute a tech transfer.
Overview of Tech Transfer in the Vaccine Industry: Part 2
Learning Objectives
Upon completion of the course, participants will be able to:
- Measure the outcomes of the tech transfer using the tools explained to decide the success of a tech transfer.
- List the possible challenges and risks associated with the tech transfer plan and design a risk assessment matrix.
Regulatory Perspectives in Tech Transfer
Learning Objectives:
Upon completion of the course, participants will be able to identify the key elements for preparation of effective regulatory strategies which would enable successful tech transfer, including the following:
- State regulators’ expectations.
- Explain expectations of the internal regulatory affairs team.
- Compare regulatory pathways or actions enabling tech transfer, including current trends and challenges.
Facility Fit Assessment (FFA)
Learning Objectives
Upon completion of the course, participants will be able to describe the methodology to perform a Facility Fit Assessment.
Tech Transfer of Typical Unit Operations
Learning Objectives:
Upon completion of the course, participants will be able to:
- Explain the typical various unit operations in upstream and downstream processing.
- State the purpose of the typical unit operations.
- List of important elements for process tech transfer.
- State examples of typical Critical Process Parameters/Key Process Parameters (CPP/KPP), critical steps, process controls, samples points that are required in a tech transfer (from sending unit to receiving unit).
- Provide examples of and list typical documents to be transferred
- Prepare an example of risk assessment accompanying sending and receiving units for TT.
Biophysical and Biochemical Assay Transfer
Learning Objectives:
Upon completion of the course, participants will be able to:
- Use a sample checklist to create an appropriate gap analysis checklist.
- Identify and create a transfer strategy.
- Define and build a master transfer plan/protocol.
- Define and build method specific transfer plan/protocol with clearly defined transfer criteria responsibilities and deviation handling.
- Perform execution (of what?), evaluate and report execution data.
- Compare results against criteria in 4th point in method specific report.
- Define and build a master transfer report.
- Explain common pitfalls of assay transfer.
Drug Product Manufacturing
Learning Objectives
By the end of this course, you will be able to:
- Describe the principles behind lyophilization
- Identify the characteristics and quality attributes of lyophilized drug product
- Explain the advantages and disadvantages of lyophilized drug and liquid drug product
- Describe the principle behind developing control strategy
- Discuss how control strategy correlates from CQAs to other elements (CPPs and QTPP)
- Determine the Risk Assessment to CQAs
- Assess the challenges of Aseptic Fillings
- Integrating technology advancements to counter the challenges of aseptic fillings
- Explain the importance of sterility testing before batch release
- Investigate the various reasons behind sterility failure
- Evaluate new guidelines of sterility control
- Summarize what pharmaceutical technology transfer is about
- Recognize the reasons for product tech transfer
- Recognize the phases of the project and key considerations of tech transfer
- Identify the key criteria for a successful tech transfer and the pitfalls