Regulations & quality and bioproduction

Level 1 -

Bioprocessing: Downstream Process and Drug Product Development

Presentation

Why participate?

Understand the stages of Downstream Processing, formulation, and Drug Product Development

Training Context:

Downstream Processing (DSP) and Drug Product Development are key steps in the manufacture of biopharmaceuticals.
DSP focuses on the purification and quality of the active substance by removing impurities and ensuring product stability.
Simultaneously, Drug Product Development aims to formulate the final drug to ensure its efficacy, safety, and compliance with regulatory standards.

Learning objectives

  • Master purification techniques: Ensure the quality and purity of biopharmaceuticals through effective purification methods
  • Optimize yield and productivity: Maximize process yield and stability while maintaining active substance efficacy
  • Integrate final product formulation: Design stable and bioavailable formulations that meet safety standards
  • Meet regulatory requirements: Apply compliance standards to fulfill health authority expectations
  • Improve scalability: Develop scale-up strategies for efficient large-scale production

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

R&D Managers, Project Leaders, Production Engineers and Technicians, Academic Researchers

Prerequisites

Solid knowledge of biotechnology/biochemistry and therapeutic antibodies or recombinant proteins, or prior completion of the courses “Fundamentals of therapeutic antibodies” or “Introduction to biomanufacturing”

Duration

1 day, 7 hours

Price

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

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Trainers

Catalogue de formations-MabDesign-2023.pdf (9)

Alexandre

FONTAYNE

Expert consultant, Founder
BE4S
CSO for Biological Products
Unither Pharmaceuticals

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