Bioprocess Engineering II: Specifics of Applications

This course unit presents the specific characteristics of healthcare applications in the field of bioprocessing. It includes case studies on the production of biopharmaceuticals and advanced therapy medicinal products (e.g., the production of clinical-grade cell therapy products). The entire production chain is covered, with a particular focus on downstream processes (Downstream Processing, DSP), which are especially important for healthcare products (separation, extraction, purification, and even formulation). Indeed, DSP accounts for a significant portion of production costs, and there are numerous expectations and challenges associated with these technologies, particularly with the development of single-use technologies. Upstream Processing (USP) is covered in depth in the complementary course units of the Bioproduction specialization (HAV930V and HAV911V).

This course unit includes lectures and presentations, with numerous guest speakers from the industry who will share their expertise and insights with the students. Beyond the technological aspects, these presentations will also provide an opportunity to discuss Good Manufacturing Practices (GMP), quality control, and the management of economic and environmental constraints.

By the end of this course unit, students will have a comprehensive and integrated understanding of pharmaceutical bioprocesses and will be able to incorporate the economic and environmental constraints of bioprocesses in this field. They will be able to select the best process to implement for each bioproduction, while being aware of the properties and limitations of each system.

Fundamentals of Bioprocess Engineering (M1 level, Course HAV811V “Bioprocess Engineering—BATCH” or equivalent)

Recommended prerequisites: Bioprocess Engineering and Recombinant Protein Production (M2 level, course HAV930V “Bioprocess Engineering—Fed-Batch and Continuous” or equivalent, and course HAV911V “Recombinant Protein Production Engineering”)Fundamentals of Immunotechnology and Protein Engineering (M1 level, courses PAM1IIMM and PAM1IIPR or equivalent).

Assessment is based on a comprehensive continuous evaluation system (CCI).