M2 IBIS Therapeutic Engineering and Bioproduction in Biotechnology-Health APPRENTICESHIP

A teaching module focused on the professional world, with general introductions to pre-defined themes targeting the biotechnological valorization of microorganisms (antimicrobials, microbiota, probiotics, applied virology, etc.), followed by presentations by industrialists on their background, their company and/or the development of a project. This course covers both red biotechnologies (health applications), and the other colors of biotechnologies (green/agronomy, blue/marine, white/industrial, yellow/environmental).

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Within biotechnologies, the production of recombinant proteins in various prokaryotic and eukaryotic expression systems represents a mature and attractive technological field with high employability. It is also a very important area of research in which many challenges remain to be met. The bioproduction of biomedicines (recombinant proteins and monoclonal antibodies) represents a major challenge for human therapeutics, but also for the many fields of biotechnology (environmental, industrial, agronomic, marine, etc.). Before designing any biological drug involving a biomanufacturing stage, it is essential to be familiar with the different eukaryotic and prokaryotic expression systems used in biotechnology, and to have a complete overview of the biomanufacturing panorama and challenges in France, Europe and the rest of the world.

This course includes interactive lectures. It is taught by various academic and industrial contributors involved in the field.

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This course focuses on the specificities of healthcare applications in the field of bioprocessing. Case studies of biomedical and advanced therapy drug production are presented (e.g. clinical grade production of cell therapy products). The entire production chain is covered, with a particular focus on downstream processes (or DownStream Processing, DSP), which are particularly important for healthcare products (separation, extraction, purification and even formulation operations). Indeed, DSP represents a significant proportion of production costs, and the expectations and challenges associated with these technologies are numerous, particularly with the development of single-use technologies. UpStream Processing (USP) is covered in depth in the complementary modules of the Biomanufacturing specialization (HAV930V and HAV911V).

This course includes lectures and conferences, with numerous contributions from industry experts who will share their expertise and vision of the field with the students. In addition to technological aspects, these presentations will also cover Good Manufacturing Practices (GMP), quality control and the management of economic and environmental constraints.

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Turning research into industrial applications will require strategies and players at the interface between the scientific and socio-economic worlds. Identifying and protecting the innovative nature of a discovery will be followed by the search for funding and partners to turn the idea into an economic reality.

This course is designed to give students all the tools they need to develop their work into new therapeutic tools. It includes lectures by legal professors and professionals in the field, as well as a tutored project that is followed throughout the course. Work will also be carried out in the Learning Lab: identification of innovative research, drafting of a patent, valorisation plan, company creation, business plan.

This course will involve teacher-researchers, industrialists and patent and development professionals.

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Within biotechnologies, bioprocesses correspond to the industrial implementation of living tools (whether enzymes, microorganisms or eukaryotic cells) for the synthesis of products of interest. This course will focus on the central stage of the bioprocess: the biological reaction in the reactor. In particular, it will focus on the use of microbial and cellular catalysts. The products of interest may be fermented foods (wine, beer, etc.), energy molecules (bioethanol, methane, etc.), chemical intermediates or biomedicines (vaccines, monoclonal antibodies, growth factors, etc.). The knowledge and skills acquired in this course can be applied to any sector of activity. Examples will be given in fields corresponding to the main outlets of the two courses concerned (Agrosciences and Health). This course is a direct continuation of the M1 course HAV811V "Bioprocess Engineering -Batch". It focuses on the UpStream Processing (USP) aspects of bioprocessing.

The first lectures will provide an overview of bioprocesses and the approach applied in bioprocess engineering, as well as a brief reminder of the Batch mode (M1 prerequisite). The bulk of the course will then be devoted to applying the bioprocess engineering approach to reactors operating in continuous and Fed-Batch (or semi-(dis)continuous culture) modes.

Cross-disciplinary modules will also be offered:

-Transfer management (mixture management, heat transfer, gas transfer) with a focus on gas transfer and how to ensure a culture's oxygen requirements (kLa, OUR, OTR) -Design of culture media

-Elementary balances (carbon and redox balances)

-Development of a biological reaction monitoring indicator: the Respiratory Quotient (RQ)

This course includes interactive lectures and tutorials.

Students in the M2 Biology-Health / IBIS / Biomanufacturing specialization will be able to put their project into practice intensively (1 month) as part of the "Multidisciplinary lab project: from gene to protein" UEs. For these students, a strong link is also provided with the specialization courses (HAV910V, HAV911V and HAA910V). Please refer to the descriptions of these UEs for further information.

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The multidisciplinary lab project, also called "Gene to Protein project", will be a "learning by doing" project. The students will be in charge of the bioproduction of a protein using E. coli as a host. If they follow both parts of the project (1 & 2, like students from Biohealth master), they will start with strain construction and continue with pilot scale production and purification of the protein.Bioprocess engineering is a highly interdisciplinary fieldof study. The students (and future workers in the field), will benefit from project-based learning with an important practical part, where they can actively experience the interconnection between biology, engineering and physical sciences.

The part 2 of the project will be dedicated to 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 of Bioprocess Engineering and will be organized over three different periods:

-Week 1 : In Learning lab, students will participate in workshops to design and plan a production process in accordance with equipment and data available (scientific papers, reports, websites, previous results from UE "Multidisciplinary Lab Project 1"). Based on the bottlenecks identified for production of recombinant proteins in E. coli, the students will choose the culture process to be used, define the production objectives, simulate the culture (planning objective), design a sampling plan, design the culture medium...

-Week 2 :In practical training rooms on pilot-scale equipment (20L working volume bioreactor), students will prepare the bioreactor and all they need to perform the pilot-scale culture. They will be in charge of the monitoring of the culture and of real time data treatment in order to detect and correct deviations from the anticipated progress of the culture.

-Week 3 : In learning labs, students will treat and analyze the data. They will be in charge of the interpretation and discussion of the results and of the writing of a professional report.

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