Regulations & quality and bioproduction

Level base -

Impurities and Contaminants in Biotechnological Products: Sources, Prevention, and Problem Solving

Presentation

Why participate?

Ensuring the purity of biotechnological products is essential for patient safety, product efficacy, and long-term stability. Contaminants such as adventitious microorganisms (bacteria, yeasts, fungi, mycoplasmas) and viral agents (including bacteriophages in bacterial systems) must be strictly controlled. In addition, process-related impurities - such as host cell proteins, residual DNA, raw material residues, and process auxiliaries - must be minimized and characterized to mitigate potential risks to patients and product integrity.

Training Context:

This training offers an in-depth exploration of contamination risks, impurity control strategies, regulatory requirements, and practical approaches to impurity detection and elimination. Through expert discussions and case studies, participants will gain practical knowledge to design robust processes that ensure product quality and safety.

Learning objectives

  • Understand the terminology related to contaminants and impurities
  • Assess the risks that impurities pose to patients and the product
  • Master regulatory requirements for the control of impurities and contaminants
  • Identify the main sources of contaminants and impurities in biotechnological processes
  • Implement effective strategies for the prevention, detection, and elimination of impurities
  • Analyze case studies to better understand the challenges related to impurities and their solutions

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Process development scientists, manufacturing experts, QA/QC personnel, regulatory affairs CMC professionals, CMC project managers

Prerequisites

Basic knowledge of bioproduction/bioprocessing.

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr