Continuous and Intensified Biomanufacturing

Register Your Interest

Leave this field blank

By clicking register, you agree to our Privacy Policy

Implement continuous and intensified processes for biopharmaceutical manufacturing to improve quality, time and reduce costs

If you would like training for yourself or a group, complete the form above


Course Overview


Continuous and Intensified biomanufacturing has the potential to improve product quality, costs and speed up time to market. In addition to the advantages there are also challenges that must be overcome when implementing continuous bioprocessing. These include regulatory considerations, adapted technologies, development steps and validation.


Using interactive exercises and case studies this training course will enable you to understand the fundamentals of implementing a continuous manufacturing approach for unit operations, upstream or/and downstream processing. Strategies, technologies and processes helping important process intensifications are addresses as well. You will explore both the advantages and potential disadvantages. During the course, you will also review the regulatory and quality framework for continuous bioprocessing to ensure you are compliant. You will assess major steps to develop a continuous approach as well practical guidance for monitoring and controlling a continuous and Intensified bioprocessing.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.



What is included in a live online course?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

Learn more about how we deliver live online training


Key Learning Objectives


  • Understand the essential concepts of continuous bioprocessing and technologies to help you design and implement continuous and/or intensified manufacturing
  • Review regulatory and quality aspects of continuous biomanufacturing to ensure your continuous process is compliant
  • Examine key steps to develop a continuous process such as the development of unit operations, process design and process characterisation
  • Learn how best practice for integrated continuous and/or intensified biomanufacturing
  • Appreciate the potential positives and negatives of adopting continuous biomanufacturing to your situation
  • Lean to implement monitoring and control strategies to you continuous bioprocess approach to ensure product quality
  • Examine continuous and/or intensified process validation to demonstrate consistency and maintain product safety and quality.
Post Learning Implementation Plan (PLIP)


  • 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.

This course is aimed at professionals who work in biopharmaceutical manufacturing. It is suited to those who currently operate a continuous process or for those who are considering a continuous approach. These include: Bioprocess Scientists | Upstream Professionals | Downstream Professionals | Bioprocess Development Personnel | Bioprocess Engineers | Production Personnel/Technicians | Quality | Regulatory Affairs.


It is also relevant for professionals working in cell and gene therapy manufacturing. Margit has experience of working with CGT products.

Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • There are two price tiers for this course:
    • Super Early Bird Discount – Enrol approximately 3 to 5 weeks before the course starts.
    • Early Bird Discount – Enrol 7 to 10 days before the course starts.
    • The early bird dates for this course are at the top of the page, above Course Overview.


Frequently asked questions (FAQs)



Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

Leave this field blank

Select Course Dates

5 Jul 2022, Live Online


• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.