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 and subsequent questions and challenges

Introductory Module 1

Introduction and key aims of upstream bioprocessing

This session will introduce the upstream system and discuss the key objectives behind optimising your upstream bioprocess, focusing on productivity, scalability and product quality. It will also cover:

• • The selection of host cells and expression vectors
  • The process development needs for animal and microbial cell types and viral systems
  • Expression systems their possibilities and advantages

Module 2

Optimising cell line development

Essential for optimising your upstream process is ensuring a suitable cell line which is stable but also productive and practical for scale up. This session will discuss the design and selection process. It will also cover:

• Cloning, clone screening and selection for different development phases
• Examining sequencing, vector design and host cell requirements
• Reviewing stability studies
• Review case study examples of difficult to express molecules
• Cell banking and characterisation requirements
• Virus banking and characterisation requirements
• Benefit of platform cell lines and expression systems

Module 3

Considerations for upstream media selection

The selection and improvement of media is a common approach taken by the industry to boost upstream productivity and has a considerable effect on performance. This session will focus on media screening and selection as well as:

• Media evolution during process development
• Testing and characterisation of media
• Preparation, stability, testing and characterisation of media
• Viral safety and TSE concerns
• Good Manufacturing Process (GMP) considerations

Module 4

Process design and initial upstream process development

In this session you will walk through the process development phases considering different expression systems, screening models and platforms. You will also discuss:

• Optimising your upstream bioprocess
• Assess the impact of process formats such as batch, fed-batch and perfusion
• Evolutions during process development
• Controls and testing that needs implementing during initial process development
• Harvest considerations

Module 5

Integration of your upstream and downstream processes

There are a number of challenges when integrating your upstream and downstream processes. This module will focus on these challenges as well as best practices to help overcome them. You will also learn:

• Cell disruption and product recovery
• Upstream process changes & variability impacting downstream processing.
• Integrated upstream and downstream development.

Module 6

Quality considerations

Having an effective quality strategy in place is crucial to ensure you have an efficient and safe process. This module will discuss how best to implement a Quality by Design (QbD) approach and discuss risk management. In addition you will learn:

• Regulatory background
• Examining the application of QbD
• Process transfer into GMP facilities
• Experimental design
• Knowledge management

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 is an expert in upstream bioprocessing and has delivered many courses on the topic. She has helped delegates upstream bioprocess development such as cell line development and ensuring integration with downstream process. Drawing on her extensive experience Margit provides numerous case studies, examples and exercises on the different areas of upstream process during the course.