Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

16 May 2024 | 1:00 PM (UK)

Delivered Online

Introduction to tech transfer

• When, why and how tech transfers are needed
• 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
• Role of CDMOs
• Contractual requirements
• Q&A

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Session 1

24 June 2024 | 180 mins | 1:00 PM UK

Introduction to tech transfer

Regulatory, quality and technical aspects of Tech Transfer

• Regulatory guidelines and requirements/guidance
• Requirements of different classes of Biologics/Biotech derived products and Biosimilars
• Hot topics of regulators in this context
• Audits: facilities, scale, equipment, analytical capability, capacities, timeliness, storage areas fit assessment and expertise and spirit of the team
• Tech Transfer, risk analyses and change control
• Regulatory implications and product comparability, which studies need to be performed, when and how to interact with regulators
• 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
• Impacts and Mitigation plans in case differences in CQAs are detected
• Q&A

Group exercise

Together in teams, you will outline a tech transfer protocol and a comparability protocol. You can do this on your own products or as a pretend example.

Session 2

25 June 2024 | 180 mins | 1:00 PM UK

Tools to support Tech Transfer

• Planning tools and other general project management tools
• Transfer of process information: scope, identifying different components and differing nature of information. Best suited methods for each.
• Examples of a tech transfer project plan including typical steps and mile-stones
• 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, woman/man on the plant, shadowing, observation, Q&A, team building)
• Best practices
• Q&A

Group exercise

In teams, you will review and select your preferred tools to apply to your example tech transfer.

Session 3

26 June 2024 | 180 mins | 1:00 PM UK

Managing Scale Up of individual process steps as well as process integration in Tech Transfer

• Technologies and scale-up strategies; examples of cell culture, fermentation, centrifugation, filtration, TFF, Chromatography, formulation and filling operations
• Introduction to risk analysis, risk management tools and identification of risks
• Scale up as a significant risk factor: typical approaches and scale up factor. Issues encountered, by process step. Risk mitigation strategies
• Use of FMEA and process walk downs.
• Conclusions on risk management.
• Q&A

Group exercise

In teams you will review a case study and focus on risk management activities during tech transfer.

Session 4

27 June 2024 | 180 mins | 1:00 PM UK

Dealing with Complexity – Open exchange

• 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. – main criteria
• Analytical transfer: specific risks. Different formal approaches. Common problems.
• Tech transfer strategies during the life cycle.

Conclusions

• Wrap – up
• Q&A
• Feed-back

Dr Margit Holzer has over 25 years of experience in the industry and worked on more than 50 different products. She is a specialist in process, product and analytical method development for biopharmaceuticals. She has extensive expertise in bioprocess in all phases of development including preclinical production, clinical production and large-scale commercial supply.

 

Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences. She moved on to become the Quality Director and later the Technology, R&D and Innovation Director for NOVASEP in France, before setting her own consultancy. She now assists clients in the evaluation, optimisation and development of processes, analytics and technologies including innovative ones for upstream and downstream processing and formulation.

 

Margit has delivered multiple courses on bioprocess validation. She has helped delegates understand the guidelines and the steps they must take to ensure their operations are compliant. Drawing on her extensive experience Margit provides numerous case studies, examples and exercises during the course.