Introduction to Upstream Processing

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
€ 795 (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)

Module 2: Introduction to Downstream Processing (1 day). Click here for more information

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 cell culture
  • basic principles of the propagation of viruses
  • construction and maintenance of a cell bank/seed lot
  • 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

Theory

 

Biopharmaceutical Production

• In what do biotechnological products differ from chemical-pharmaceutical products (small molecules)?
• What is the difference between USP (Upstream Processing) and DSP (Downstream Processing)?
• What is the difference between DS (Drug Substance) and DP (Drug Product)?
• The production process of common biotechnological products such as antibodies, viruses and pharmaceutical proteins.

 

Pharmaceutical Microbiology

• What are microorganisms?
• Different types of microorganisms
• What do microorganisms need to live and multiply?
• How can we prevent microorganisms from ending up in pharmaceutical products?
• Sterility and how can we achieve this?
• How can you produce aseptically?
• The functioning of cleanrooms

Practice

 

Cleanroom Principles/Upstream Processing

Various techniques needed to grow bacterial and mammalian cells, including:
• Cell bank principles
• Defrost and freeze
• Required process parameters for cell culture and virus multiplication
• Challenges in cell culture and virus multiplication

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

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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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