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Upstream Process Development for Biopharmaceuticals

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This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

 

Course Overview

 

Biomanufacturing begins with upstream processing where first an adapted expression system needs to be developed (expression cell line and vectors), cultivation conditions optimised, and growth and expression optimized. It is a critical step that must be completed correctly to ensure sufficient production of the target product. Professionals working in upstream bioprocessing must balance product quality demands, upstream and integrated process productivity, speed to market and scalability.

 

This training course will give you the confidence to optimise your upstream bioprocess. You will learn to maximise performance by examining key areas of the upstream process such as cell line development and media selection. Through examples and exercises, you will understand areas of process design, transfer to GMP facilities and best practices to integrate upstream with downstream processing. You will also examine critical quality factors during upstream process development to ensure a safe product and compliance.

 

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.

Key Learning Objectives

 

  • Gain a comprehensive overview of cell line & media and upstream process development as well as the tools available to optimise your upstream process
  • Examine key elements of cell line development such as sequencing, cloning, productivity and cell banking
  • Discuss strategies for media selection and the impact this has on the performance of your upstream process
  • Examine process design considerations and development phases to develop an efficient upstream bioprocess system
  • Discuss best practices for upstream and downstream process integration to maximise biomanufacturing effectiveness
  • Understand how best to manage the transfer of the process to a GMP facility
  • Learn how to maintain quality throughout your upstream process.

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 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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.

This course is relevant for anyone working in areas of upstream process development such as cell culture, cell line development and process development. 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.

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