Course description
Tech Transfer for Biopharmaceutical Manufacturing
Fail to prepare, prepare to fail.
The importance of performing an efficient and thorough Tech Transfer cannot be understated in the world of Biopharmaceutical Manufacturing. Failure to transfer your process correctly will cost you time and money, as well as increase the time to market for your drug. This 2-day highly interactive course will utilise a continuous case study and group exercises to cement knowledge gained of planning a Tech Transfer, you are also encouraged to bring specific challenges you’ve experienced to the course to receive expert advice on them.
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Suitability - Who should attend?
A Tech Transfer is led via a collaboration between project managers and process development at both sending and receiving site. This course is especially relevant for those departments but will also be beneficial for professionals working in biomanufacturing, quality departments and managers.
Outcome / Qualification etc.
- Learn how to define a successful Tech Transfer operation
- Learn what risks are associated with the Tech Transfer process, and how to effectively manage them
- Learn what is formally required by the regulators for a Tech Transfer to take place
- Understand the different types of Tech Transfer that can take place for a biopharmaceutical, such as R&D to manufacturing, and how you transfer analytical methods to ensure product realisation
- Learn what tools are available to facilitate a Tech Transfer, including process maps, SOPs and the RACI matrix
Training Course Content
Session 1
Introduction to Tech Transfer
- Delegate introduction: specific expectations
- Definition of Tech Transfer in this context
- Different types of tech transfer and why it is common in our industry; challenges of tech transfer
- Tech transfer as a Project: objectives, stakeholders, deliverables and success criteria project phases, resources, planning tasks and milestones, documentation, risks and reporting
- Group exercise – case study
Formal aspects of Tech Transfer
- Contractual aspects
- Regulatory requirements / guidance
- Tech Transfer and change control
- Regulatory implications and product comparability
- Procedure, Protocol, Report: needs and functions
- Essential components of procedure/protocols and reports: donor and acceptor sites; roles and responsibilities; resources; documentation received and created; identification of changes; points to consider systematically; dealing with analytics; planning; success/acceptance criteria, risk management
- Group Exercise – outlining a TT protocol
Session2
Tools for Tech Transfer
- Planning tools and other general project management tools
- Transfer of process information: identifying different components and differing nature of information. Best suited methods for each.
- Common formats for product, process, raw material and analytical information (e.g. reports, process description, , BFDs etc).
- Importance of close communication between sending and receiving sites. Soft tools (meetings, shadowing, observation, Q&A, team building)
- Group exercise: pick your preferred tools
Session3
Managing Scale Up and other Risks in Tech Transfer
- Different types of risk in tech Transfer
- Introduction to risk analysis and identification of technical risks
- Scale up as a significant risk factor: typical approaches and scale up factor. Issues encountered, by process step. Risk minimisation
- Risk management tools. Use of FMEA and process walk downs.
- Conclusions on risk management.
- Group exercise: case study – risk management
Session4
Dealing with Complexity
- Different types of tech transfer: what makes a tech transfer more or less complex? Nature of product / process; changes; maturity of donor and recipient; stage in life cycle; cultural gap.
- Experimental components in a tech transfer: lab work, pilot runs, engineering runs.
- Selection of a receiving site. What criteria?
- Analytical transfer: specific risks. Different formal approaches. Common problems.
- Tech transfer during the life cycle: what changes. Good and bad timing of tech transfer.
- Introduction to personal assignment
Personal / group assignment: Tech Transfer in the Life Cycle. The assignment is presented in session 4 and results will be shared in session 5.
Session5
Final session
- Review of assignment
- Q&A
- Conclusions
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
The course was extremely informative, Thomas had a vast amount of knowledge to pass along regarding tech transfer. Each topic relating to tech transfer was efficiently and thoro...