Introduction to Downstream Processing

Operations Quality R&D
Training
  1. Short description
  2. Objectives
  3. Target group
  4. Program
  5. Questions?
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Due to the realistic production environment of our state-of-the-art facility, we are able to offer this unique training, which focuses not only on theory but also on the practice of manufacturing biopharmaceutical products.

Duration
1 day
Course fee
€ 895 (excl. VAT)

Short description

This course provides all background information needed to fully understand the problems that may arise during the production of pharmaceutical products. The theory section explains the basis of various aspects that are essential for the production of biopharmaceutical products. Various important techniques are discussed.

The practical part takes place in a real production environment, allowing the participants to experience the importance of working in a cleanroom. Various techniques are performed either by the students themselves, or demonstrated by an experienced operator.

The course consists of 2 modules which can also be followed separately:

Module 1: Introduction to Upstream Processing (1 day). For more information click here

Module 2: Introduction to Downstream Processing (1 day).

Objectives

After the training sessions, the participants have knowledge of:

  • the different process steps that are important for the production of (bio)pharmaceutical products
  • basic principles of various purification techniques for use in downstream processing, including chromatography, ultrafiltration, diafiltration and centrifugation.
  • various virus elimination and inactivation techniques
  • the operation of sealing and welding equipment
  • pharmaceutical microbiology
  • basic principles of working in a cleanroom

Target group

Anyone who wants to know more about the production of biotechnological pharmaceutical products. These may include for instance production operators, QA, Regulatory Affairs staff and auditors.

This course is also intended for QC analysts and validation staff who want to increase their pharmaceutical knowledge in the field of biotechnological products.

Program

Day 1

 

Theory: Production Process/Pollution Profile

What are common contaminants that can arise during the production of biotechnological medicines and how can they be removed during the downstream process?
 

Theory: Virus inactivation and virus removal

Which techniques can be used to remove or inactivate viruses?
 

Theory: DSP Techniques

Various techniques, downstream processing techniques, including:
• Chromatography
• Clarification (e. g. with filters)
• Ultrafiltration/diafiltration (UF/DF)
• Formulation
• In process controls (IPC)
 

Theory: Critical aspects during production
 

Practice: Welding; the use of welding devices
 

Practice: DSP in Practice

• Sampling techniques
• Clarification
• Chromatography
• Ultrafiltration/diafiltration

The above techniques are carried out in a practical, real-life environment, where certain aspects are performed by the participants themselves and other aspects are shown and explained in a demonstration.

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Knowhow.
Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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