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.
Interactive Teaching, Case Studies, Experience Sharing
Process development scientists, manufacturing experts, QA/QC personnel, regulatory affairs CMC professionals, CMC project managers
Basic knowledge of bioproduction/bioprocessing.
Registering online or by e-mail is a pre-registration. We will process your request within one week:
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