Sale

Continuous Manufacturing (ICHQ13) Strategies for Biopharmaceuticals

14 & 15 November 2024 | Short Online Course

Original price was: £495.00.Current price is: £396.00.

2-day Live Online Training 

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

Clear

Course Overview

 

Continuous 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.

 

This short live online training course will enable you to understand the fundamentals of implementing a continuous manufacturing approach for unit operations, upstream and downstream processing. During the course, you will 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 as practical guidance for monitoring, controlling and validating continuous bioprocessing.

 

Learn more about how we deliver live online training.

Register Early to Save

 

Enrol before 18 October to save 20% (November Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Key Learning Objectives

 

  • Understand the essential concepts of continuous bioprocessing and technologies to help you design and implement continuous manufacturing
  • Review regulatory and quality aspects (ICHQ13) of continuous biomanufacturing to ensure your continuous process is compliant
  • Examine key steps to develop a continuous process such as the upstream and downstream technologies available to implement a successful continuous approach
  • Appreciate the potential positives and negatives of adopting continuous biomanufacturing to your situation
  • Learn to implement monitoring and control strategies to your continuous bioprocess approach to ensure product quality
  • Examine continuous process validation to demonstrate consistency and maintain product safety and quality

What is Included?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Download the Agenda

 

You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.

Leave this field blank

By clicking submit, you agree to our Privacy Policy

Course Dates

 

Find out when this course is running so you can plan your training.

14 & 15 November 2024

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

2025 Dates TBC

7-Hour Course Delivered Over 2-Days
Register at the top of the page.

2025 Dates TBC

7-Hour Course Delivered Over 2-Days
Register at the top of the page.

Learn more about the course by toggling through the tabs below (trainer, who should attend?)

 

Course Outline

Course Information

  • The course begins at the time stated below
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1 | Day 1

14 November 2024

210 mins | 1:00 PM UK

Introduction

  • Introductions and overview of the course and format

Overview of continuous biomanufacturing

  • History of continuous manufacturing
  • Reviewing and understanding the pros and cons of a continuous approach in biotech
  • Latest technologies for large-scale production of recombinant proteins
  • The necessity for flexible manufacturing processes
  • The challenge of managing manufacturing costs
  • The implementation of single-use systems

Upstream perfusion technologies

  • Principles of various cell culture modes: batch, fed-batch, intensified fed-batch, and perfusion
  • Examine cell metabolism in fed-batch vs perfusion
  • How to move from batch to perfusion system:
    • Cell retention technologies
    • Continuous media feed

Downstream technologies

  • Fundamentals of continuous chromatography
  • Available technologies based on chromatography resins
  • Continuous viral inactivation
Session 2 | Day 2

15 November 2024

210 mins | 1:00 PM UK

Regulatory & quality considerations for continuous biomanufacturing

  • Understand the current regulatory landscape
  • ICH, EU and US FDA Guidelines
  • Review of ICH Q13
  • Steady-state vs State-of-Control
  • Understand the diversion points
  • Review the limitations for biopharmaceutical processes
  • Expectations for Process Analytical Technologies (PAT

Validation for continuous processes

  • General principles of process validation
  • Understand the key differences to classical batch processing
  • Continuous process performance qualification and batch definition
  • Setting-up the control strategy
  • Residence time distribution
  • Continuous viral clearance
  • Continuous filtration
  • Bioburden control

The future of continuous processing

  • What are the latest purification technologies?
  • Review the business case for continuous manufacturing
  • Further development of Process Analytical Technologies
  • Real-time of drug substance release (RTR)

Conclusion

  • Wrap and summary of the course
  • Questions and answer session

Mylène Talabardon – With over 20 years of experience in the pharmaceutical industry, Mylène has strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from the lab scale to manufacturing scale. In 2004, she was appointed head of the cell culture department at Merck Serono and started working in validation according to QbD for biotechnological products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

Hervé Broly – Starting with an engineering degree in agriculture, followed by a PhD in plant physiology,  Hervé joined the Blood Transfusion Center (Lille, France) in 1982 where he implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, Hervé took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. He took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994.

In 2003, Hervé moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.

As of November 2006, Hervé has been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.

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 Professionals
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.

 

Complete our contact form by following the link. Get in touch.

*

• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training

Reviews

There are no reviews yet.

Be the first to review “

Continuous Manufacturing (ICHQ13) Strategies for Biopharmaceuticals

14 & 15 November 2024 | Short Online Course

Your email address will not be published. Required fields are marked *