M2 IBIS Therapeutic Engineering and Bioproduction in Biotechnology and Health APPRENTICESHIP

A course module focused on the professional world, featuring general introductions to predefined topics centered on the biotechnological applications of microorganisms (antimicrobials, microbiota, probiotics, applied virology, etc.), followed by presentations from industry professionals who share their career paths, their companies, and/or the development of a project. This course unit covers both red biotechnology (health applications) and other types of biotechnology (green/agronomy, blue/marine, white/industrial, and yellow/environmental).

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Within the field of biotechnology, the production of recombinant proteins in various prokaryotic and eukaryotic expression systems represents a mature and attractive technological field with strong employment prospects. It is also a very important area of research in which many challenges remain to be addressed. The bioproduction of biopharmaceuticals (recombinant proteins as well as monoclonal antibodies) is a major issue not only in human therapeutics but also in numerous fields of biotechnology (environmental, industrial, agricultural, marine, etc.). Before designing any biological drug that involves a bioproduction step, it is essential to understand the various eukaryotic and prokaryotic expression systems used in biotechnology, as well as to have a comprehensive overview of the landscape and challenges of bioproduction in France, Europe, and around the world.

This course unit consists of interactive lectures. It is taught by various faculty members and industry professionals working in the field.

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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.

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Translating research into industrial applications will require strategies and stakeholders operating at the intersection of the scientific and socioeconomic worlds. Identifying and protecting the innovative nature of a discovery will be followed by the search for funding and partners to turn that idea into an economic reality.

This course unit will focus on providing students with all the tools they need to showcase their work with a view to discovering new therapeutic tools. This course unit includes lectures delivered by law faculty members and professionals in the field, as well as a supervised project that students will work on throughout the course unit. Work will also be conducted in the Learning Lab, including identifying innovative research, drafting a patent application, developing a commercialization strategy, starting a business, and creating a business plan.

This course will feature faculty members, industry representatives, and professionals in the fields of patents and technology transfer.

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Within the field of biotechnology, bioprocesses involve the industrial application of biological tools (such as enzymes, microorganisms, or eukaryotic cells) for the synthesis of products of interest. This course unit will focus on the central stage of the bioprocess: the biological reaction in a reactor. It will specifically address the use of microbial and cellular catalysts. Products of interest may include, for example, fermented foods (wine, beer, etc.), energy molecules (bioethanol, methane, etc.), chemical intermediates, or biopharmaceuticals (vaccines, monoclonal antibodies, growth factors, etc.). The knowledge and skills acquired during this course unit will be transferable to any sector of activity. Examples will be provided in fields corresponding to the main career paths of the two relevant degree programs (Agrosciences and Health). This course unit is a direct continuation of the M1 course unit HAV811V “Bioprocess Engineering—Batch.” It focuses on the Upstream Processing (USP) aspects of bioprocesses.

The first few classes will provide an overview of bioprocesses and the approach used in bioprocess engineering, as well as a brief review of batch mode (a prerequisite for the M1 program). The bulk of the course will then be devoted to applying the bioprocess engineering approach to reactors operated in continuous and fed-batch modes (or semi-continuous/discontinuous culture).

Cross-disciplinary modules will also be offered:

-Transfer processes (mixing, heat transfer, gas transfer) with a strong focus on gas transfer and how to meet a culture’s oxygen requirements (kLa, OUR, OTR).-Design of culture media

-Basic balances (carbon balance and redox balance)

-Development of an indicator for monitoring biological response: the Respiratory Quotient (RQ)

This course unit includes interactive lectures and tutorials.

An intensive (1-month) practical application component, carried out in the form of a project, is planned for students in the M2 Biology-Health / IBIS program with a specialization in bioproduction as part of the course units “Multidisciplinary Lab Project: From Gene to Protein.” For these students, a strong connection is also planned with the specialization course units (HAV910V, HAV911V, and HAA910V). Please refer to the course descriptions for these units for more information.

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The multidisciplinary lab project, also known as the “Gene to Protein project,” will be a “learning by doing” project. The students will be responsible for the bioproduction of a protein using E. coli as a host. If they complete both parts of the project (Parts 1 and 2, as students in the Biohealth master’s program do), they will begin with strain construction and proceed to pilot-scale production and purification of the protein. Bioprocess engineering is a highly interdisciplinary field of study. The students—and future professionals in the field—will benefit from project-based learning with a significant practical component, where they can actively experience the interconnection between biology, engineering, and the physical sciences.

Part 2 of the project will focus on the “production process design and pilot-scale production” of the recombinant protein using a high-cell-density fed-batch culture. It will be a multidisciplinary, hands-on training program in bioprocess engineering and will be organized over three distinct periods:

-Week 1: In the Learning Lab, students will participate in workshops to design and plan a production process based on the available equipment and data (scientific papers, reports, websites, and previous results from the “Multidisciplinary Lab Project 1” course unit). Based on the bottlenecks identified in the production of recombinant proteins in E. coli, students will select the culture process to be used, define the production objectives, simulate the culture (planning objective), design a sampling plan, and formulate the culture medium...

-Week 2: In practical training labs using pilot-scale equipment (a 20-liter bioreactor), students will set up the bioreactor and prepare everything needed to conduct the pilot-scale culture. They will be responsible for monitoring the culture and processing real-time data in order to detect and correct deviations from the expected progress of the culture.

-Week 3: In the learning labs, students will process and analyze the data. They will be responsible for interpreting and discussing the results and for writing a professional report.

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