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

FREE to Attend | Live & Recorded

Sign up

8 June 2022 | 60 mins | 1pm UK

Introduction to continuous biomanufacturing

• History of continuous manufacturing
• Where are we now
• Reviewing and understanding the pro’s and cons of a continuous approach in biotech

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.

Module 2

5 July 2022  | 90 mins | 10am UK

Regulatory & quality considerations for continuous biomanufacturing

Understanding the current regulatory and quality expectations is crucial before making any changes in your process design. Here we will focus on some of the key guidelines currently driving the industry.

• • Understand the current regulatory landscape
  • ICH, EU and US FDA Guidelines
  • Quality considerations for a continuous process
  • Implementing a Quality by Design approach into a continuous process

Module 3

5 July 2022 | 90 mins | 1pm UK

Steps to develop a continuous process

In this session you will examine the key steps to create a continuous process such as developing unit operations, process design and process design.

Within this session you will be able to see how unit operations such as in-line dilution, perfusion cell culture, chromatography, tangential flow filtration (TFF), pH adjustments, virus inactivation and reactions can be developed. We then look at how these can then be integrated into a process

• • Development of unit operations and applications
    • In-line dilution / Perfusion cell culture / Chromatography / Tangential flow filtration (TFF) / pH adjustments / Virus inactivation / Reactions
  • Process design
  • Bridge batch to continuous
  • Process integration
  • Process characterisation
  • Process scheduling
  • Facility design and organisational considerations
  • Examining cost studies

Module 4

6 July 2022 | 90 mins | 10am UK

Steps to develop a continuous process continued

A continuation of Module 3

Module 5

6 July 2022 | 90 mins | 1pm UK

Implementing process monitoring and control strategies into your continuous biomanufacturing approach

Using case studies and discussion you will consider what control strategies are available to you as well as how best to implement these into your process. You will also discuss challenges and how best to handle any out of range and out of spec scenarios.

• Process and product control possibilities
• Use of feedback feedforward control
• Incorporating Process Analytical Technologies (PAT)
• Reviewing sensors
• How to define op and prod ranges
• Sampling strategies
• Data trending
• Product release and Real Time Release Testing (RTRT) considerations
• Process disturbance testing
• Residence time distribution
• Equipment and automation

Module 6

7 July 2022 | 90 mins | 1pm UK

Implementing process monitoring and control strategies into your continuous biomanufacturing approach continued

A continuation of module 5

Module 7

8 July 2022 | 90 mins | 1pm UK

Continuous process validation

You will discuss the stages of process validation, requirements to consider and how to implement process performance qualifications.

• Examine the three stages of process validation
• Understand the key differences to classical batch processing
• Continuous process performance qualification and batch size
• Continued process verification

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 many courses on continuous bioprocessing. She has helped delegates understand the guidelines and the development steps so they can implement their own continuous biomanufacturing process. Drawing on her extensive experience Margit provides numerous case studies, examples and exercises on continuous bioprocessing during the course.