Industrial biotechnology at ITMO 

The Master’s program Industrial Biotechnology was launched in the fall semester of 2022. It is aimed at students who hold a Bachelor’s degree in biotechnology and want to gain a deeper understanding of the modern food and pharmaceutical industries while accumulating valuable practical experience. 

The curriculum of the program emphasizes the technological aspects of the manufacturing processes, with classes taught by the industry’s leading experts: for example, Ruslan Al-Shekhadat, the CEO of the biotechnology company Innova Plus, serves as the head of the program. Better yet, some of the educational tracks have been fully developed by the program’s industrial partners.

One such example is a track by GEROPHARM, one of Russia’s largest manufacturers of pharmaceutical and biotechnology products, which has its own R&D center. Specialists at the center work on new medication, run preclinical and clinical trials, register and implement new technologies into industrial-scale manufacturing, as well as handle pharmacovigilance studies.

By collaborating with ITMO, the program’s partners can essentially train their future employees, giving students the opportunity to start working while studying or immediately after graduation. Additionally, this track offers GEROPHARM’s researchers an opportunity to try teaching or prepare for their thesis defenses.

“We train specialists who are uniquely qualified to work in every sector of the biotechnology industry. They will never be told ‘forget everything you’ve been taught at university,’ since our program is, in essence, the first chapter of their careers. Our goal is for every student to have found employment by the time they start working on their thesis,” says Ruslan Al-Shekhadat, the head of the program.

Ruslan Al-Shekhadat.Photo by Dmitry Grigoryev / ITMO.NEWS

Ruslan Al-Shekhadat.Photo by Dmitry Grigoryev / ITMO.NEWS

The first students

Only 12 students have made it into the first run of the track – the participants were picked directly by representatives of GEROPHARM. Among the requirements they had to meet were: authored articles in relevant fields published by high-profile journals, certificates of student competitions and contests, and additional learning experience (vocational and continuing professional education, language testing certificates). Points were also given for work experience at laboratories as part of research groups or as interns.

In addition, the applicants were to solve three cases and demonstrate their ability to analyze bioengineering tasks and complete them. One such task involved devising a way of removing an admixture from adenoassociated viruses (used to deliver genetic material during treatment of monogenic disorders); another called on the students to describe the process of extraction of recombinant proteins.

About the curriculum

The track’s main goal is to foster specialists capable of entering professional practice immediately upon graduation, no additional training required. That is why throughout all four semesters the students will be familiarized with all stages of pharmaceutical production: from early development and pre-clinical in vitro / in vivo tests to clinical testing and certification.

Students will also be taught specific skills that are essential for pharmaceutical biotechnologists. In the spring semester, they’ll learn about the design and growth of producer strains of recombinant proteins (a base element of pharmaceutical products); and in the fall semester – about the ways of purifying proteins and nucleic acids. Students will find out about modern trends, too – a separate course will deal with digitization and mathematical modeling in biotechnologies. 

The track is structured so as to fill in the gaps that the company most often encounters when selecting candidates for internships or employment. For instance, as Zukhra Khasanshina, the head of GEROPHARM’s genetic engineering and fermentation laboratory, as well as a lecturer on the subject of recombinant protein design, points out, students often lack practical skills that are a must-have for biotechnologists.

“I interact with students a lot and I’ve found that competencies related to the cultivation of producer strains is something that often isn’t given enough attention. Some universities train great molecular and cellular biologists, others – biochemists, who understand the physical and chemical properties of protein; an essential competency for those who work with purification. But the cultivation stage, which concerns the merging of the strain and the protein, is overlooked. That’s why our goal with this course is to familiarize students with not only the fundamentals of producer strain design, but also the essentials of planning the conditions for the cultivation of these strains. I want our students to better understand the development process for biotechnological products and be familiar with all its stages.”

Zukhra Khasanshina. Photo courtesy of GEROPHARM

Zukhra Khasanshina. Photo courtesy of GEROPHARM

Regulations and management

The track’s most extensive and all-encompassing course will concern the development, manufacture, and distribution of pharmaceutical products in accordance with the GxP principles. According to Ivan Giba, PhD, a lecturer at the course and the head of GEROPHARM’s R&D quality assurance department, this is because Russian universities today don’t offer full-fledged courses that would allow future members of the pharmaceutical industry to learn about the regulations that concern every stage of medical products’ lifecycle. 

“The pharmaceutical industry is the second most heavily regulated after nuclear energy. There is a great amount of regulatory documents, both Russian and international, that must be followed to the letter if we want to see our product on the market. This course’s aim is to make students familiar with these requirements so they would know which “rules” define their work and why,” says Ivan Giba.

Ivan Giba. Photo courtesy of GEROPHARM

Ivan Giba. Photo courtesy of GEROPHARM

A second, no less important part of the course will be dedicated to management systems used in the development and manufacture of medical products. Knowledge of this topic will be helpful not only to future managerial staff, but to line workers, too – helping them understand their part in the grand scheme of pharmaceutical production, as well as that of the adjacent departments they’ll be working with.

Educational process

Each of the courses involves an individual or team project. For instance, the course on recombinant proteins will ask the students to develop their own strategy for boosting the protein yield and plan the corresponding experiment. Then, they’ll also have to come up with and model a bioreactor.

The students will also get the opportunity to visit GEROPHARM’s R&D and production facilities, write their theses under the guidance of the company’s staff, and intern at its laboratories.