Early Downstream Process Development

Course summary
2 weeks
1,200 GBP
Online courses
Professional Training

Course description

Early Downstream Process Development

Downstream process operations are essential to ensure you obtain your target biologic in its purest form. Consisting of core sequential steps, it is important to streamline your early downstream process in order to maintain bioprocess efficiency.

On this virtual classroom course, you will consider the best practices for developing an early downstream process considering important issues including; biologic type, separation principles, membrane-process steps, and upstream integration. Additionally, you will also explore core separation technologies including; bio-chromatography, flocculation, crystallization, and pegylation. You will be able to cement your knowledge during interactive case study sessions.

Suitability - Who should attend?

This course is directly applicable to those who are new to downstream process operations or established downstream process professionals wishing to further their knowledge of new technologies. Likewise, this course is also applicable to those working in upstream who need to understand how to integrate the process. Relevant job departments may include:

  • Downstream Process Development
  • Upstream Process Development
  • Research Scientist
  • Process Development
  • Quality Control

Outcome / Qualification etc.

  • Understand the main objectives of downstream processing and what the regulators expect.
  • Explore core underlying principles of bio-chromatography, including interactions between stationary/liquid phases.
  • Familiarise yourself with key reaction steps in downstream processing such as: redox reactions and pegylation, solubilization, heat treatment and detergent treatment.
  • Develop an early downstream process taking into consideration factors such as screening, bio-chromatographic technologies, and scale-up. Consider membrane-based process steps and appreciate the importance of cleaning/testing, optimization, and viral filtration.

Training Course Content

Session 1

Welcome and Introduction

Downstream Processing Objectives & Regulatory Background & Quality Considerations

This session will explore common downstream processing objectives and consider the following:

  • Types of products
  • Examine key technologies
  • Discuss processing strategies for:
    • Product recovery
    • Capture
    • Purification
    • Polish
  • Consider safety (product & personnel)
  • Explore general guidelines
  • Quality by Design
  • Experimental design
  • Knowledge management
  • Risk management


Bio-Chromatography Fundamentals

This session will examine fundamental principles of bio-chromatographic techniques that drive downstream process operations.

You will learn:

  • Separation Principles Bio-Chromatography Techniques
    • Interactions between the stationary /liquid phase and proteins, sugars, DNA/RNA, lipids based on structural/functional elements
    • Processing sequence and objectives: equilibration, load, wash, elution, regeneration, storage
  • Objectives
    • Separation
    • Purification
    • Polish
    • Viral clearance & removal of other safety-relevant impurities like endotoxins
  • Stationary phases
  • Membrane adsorbers
  • Liquide phases


Bio-Chromatography Process Development, Characterization and Industrialization

This session will explore how to establish a bio-chromatographic process and will include talks on:

  • Chromatography Process Development
    • Screening
    • Development
    • Optimization
    • Characterization
  • Bio-Chromatography Technologies & Formats
    • Types/ dimensions/materials of columns and systems based on supplier portfolio
  • Downscale models
  • Scale-up and Process Transfer
  • Cleaning and regeneration
  • Industrial Considerations (column packing, testing, buffer preparation, etc.)
  • Industrial Applications

Case study


Types of membranes, Process Development, Characterization and Industrialization

This session will focus on membrane separation processes and will include talks on:

  • Principles of membrane-based processes
  • Objectives
  • Formats
  • Viral filtration
  • Depth filter
  • Sterile filtration
  • Membrane Process Development
    • Screening
    • Development
    • Optimization
    • Characterization
  • Cleaning & testing
  • Downscale models
  • Scale-up and Process transfer
  • Industrial Considerations
  • Industrial Applications


Other Separation Technologies & Reaction steps

This session will consider other key technologies which can be utilised in separation processes.

  • Flocculation
  • Precipitation
  • Crystallization
  • Centrifugation

Understand key reaction steps involved in early downstream process development including;

  • Oxidation & Reduction & Pegylation
  • Enzymatic steps
  • Solubilization
  • Heat treatment
  • Solvent & detergent treatment
  • pH shifts


Process Integration

Consider the best practices for upstream and downstream processes integration, including:

  • Integration USP & DSP
  • Harvesting
  • Cell disruption & product recovery
  • Product extraction
  • Product capture
  • DSP & formulation,
    • concentration &
    • Buffer considerations (pH, composition, strength)
  • Batch vs continuous processing

Control strategy development and implementation

Learn to control the efficiency of your early downstream process by considering:

  • Definitions
  • Sensors & Control
  • Control Loops
  • Control Hierarchy
  • Process & Product Monitoring & Control


  • Quiz

Discussion session

  • Conclusions and Feedback

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


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About provider

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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