Regulations & quality and bioproduction

Level 1 -

Evaluating the Developability of a Biopharmaceutical: CMC from Molecule to Bioprocess

Presentation

Why participate?

Anticipate needs and challenges. Understand the key issues related to the developability of a biopharmaceutical

Training Context:

Developability is a critical factor for the successful production of a biopharmaceutical. Is the product stable enough in a high-yield context? Is the process robust and scalable? It is essential to project ahead to the industrialization phase (scale-up, high yield, flow management…) to anticipate and prevent potential problems early on.

Learning objectives

  • Gain a comprehensive understanding of the parameters that can impact developability (molecular characteristics and industrialization capability)
  • Pharmaceutical formulation capability and associated delivery devices (medical devices)
  • Identify and anticipate risks and reduce uncertainties in the development of the candidate molecule

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

R&D, CROs, CDMOs, manufacturing project managers, business developers, process engineers and technicians

Prerequisites

Prior knowledge of biopharmaceutical development (project management, overview, bioproduction) or completion of the courses “From Discovery to Commercialization: Development of a Biopharmaceutical Candidate” or “Introduction to Bioproduction”

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

Labatut René

René

Labatut

Expert Consultant indépendant & CEO
R.PRONOEO

Rating

Participant satisfaction rate :

4.5/5
(average over 9 people).

Return rate of satisfaction questionnaires :

100%

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