2018/2019

2019/2020

DM270

CHIM/11 (CHEMISTRY AND BIOTECHNOLOGY OF FERMENTATIONS)

DEPARTMENT OF BIOLOGY AND BIOTECHNOLOGY "LAZZARO SPALLANZANI"

ADVANCED BIOTECHNOLOGY

PERCORSO COMUNE

2°

1st semester (01/10/2019 - 14/01/2020)

6

48 lesson hours

Italian

ORAL TEST

SELVA ENRICO (titolare) - 3 ECTS
UBIALI DANIELA - 3 ECTS

The course is intended for students who have achieved the final stage of their education programme and are thus ready to apply the theoretical knowledge acquired so far to the development of autonomous and original ideas for the proposal/optimization of industrial projects concerning biotechnological processes/products.

Introducing the students to approaches, problems and trade-off situations typical of industrial workplaces in biotechnology. Provide the students with the tools and knowledge necessary to analyze and develop an industrial research project in the biotech area. Provide students with experience of team working in interdisciplinary contexts by creating tailor-made case studies for open discussion in the classroom.

The course aims at introducing the students to approaches typical of the biotech industry by examining industrial cases of research and development of bioactive molecules.
Starting from a case-study of a known antibiotic, the interdisciplinary and complex discovery process of bioactive molecules produced by microorganisms will be examined. The process development for the supply of a bioactive microbial product will be then presented by examining fermentation, down processing and strain development. The multiple interactions of these approaches will be discussed, along with the issues of process management, industrial organization, team working and intellectual property.
Some case-studies of process development for the synthesis of APIs (Active Pharmaceutical Ingredients) by biocatalysis will be presented. Advantages and disadvantages of using isolated enzymes as biocatalysts in organic chemistry will be discussed, with a focus on the most used enzymes in industry (hydrolases, transferases, oxidoreductases). The pipeline of the development of a biocatalytic process will cover the selection of the enzyme, the “transformation” of the selected enzyme into a biocatalyst active and stable under the operative conditions dictated by the specific industrial process, the enzymatic reaction set up, the scale-up of the biotransformation and the product downstream.
The product development process will be subsequently examined in view of regulatory requirements and emerging medical needs. Cases of anti-infective drugs will be examined, from the development stage to their therapeutic use. The life-cycle of a drug and the business models of Big Pharma and Biotech companies will be also discussed.

Lectures. Prof. Selva and Prof. Ubiali will be always in the classroom at the same time in order to maximize the interaction with the audience.
Seminars of experts from research centres and chemical companies will be also given. Simulations of industrial cases and problems will be run during the course and the impact assessment of the solutions proposed by the students will be analyzed. Real-life cases from different industrial backgrounds which reflect different process/product development stages will be proposed. A particular emphasis will be given to the multidisciplinary approach required by a biotech process developed to obtain new bioactive molecules or APIs, either by fermentation or by biocatalysis.
Case-studies from scientific literature will be presented to stimulate class discussions about approaches, issues and decision processes typical of the industrial environment.
Training in experimental design (how to improve/optimize a fermentation process by DoE, Design of Experiments).

Slides used during lectures and papers (provided as pdf files, also available in the Kiro website).
K. Faber “Biotransformations in Organic Chemistry – A textbook” Springer Ed.

Oral exam.
Mode: Simulation of a meeting in a biotech company with the professors in the role of R&D directors; the goal is to decide the Stop / Go of the project proposed by the students.
Starting from recent scientific publications selected by the professors, students are required to develop products/services of interest to a potential customer. Students are thus required to organize themselves as a research group (6-10 people/group) similar to the research group that has published the selected publication, to analyze the publication by a multidisciplinary approach, thus highlighting strength-points and weaknesses, to identify the desirable product/process specifications for the customer, to define what needs to be done, starting from the state of the art, to propose the product/service to the customer, to develop a realistic work plan (Gantt chart) to reach the goal, to communicate the work plan to the supervisors (R&D directors). Each student in each group has a specific role in the project and is required to present his/her contribution to the R&D directors.
Evaluation criteria: individual assessment of the contribution of each student to the development of the project. The individual evaluation will be integrated with the evaluation of the overall work of the team.

None.