The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
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Issues of mutually beneficial cooperation were discussed by representatives of FSI «SID & GP» and colleagues from GE Healthcare Life Sciences

On 24 October, the representatives of the Federal State-funded Institution «State Institute of Drugs and Good Practices» held a business meeting with foreign and Russian colleagues from the GE Healthcare Life Sciences company. This meeting provided an opportunity to discuss potential cooperation, to share the experience of collaboration with foreign pharmaceutical partners, as well as to learn about state-of-the-art technology solutions and approaches to organization of manufacture of biopharmaceuticals.

The meeting was started with presenting the Institute to the industry colleagues. The Director of FSI «SID & GP» Mr. Vladislav Shestakov outlined the main areas of activity of the Institute and vectors of its development, talked about educational programs implemented by the Institute and about establishment of the training center. Special consideration was given by Mr. Shestakov to the overall growth of the pharmaceutical industry in the country and the «Pharma-2030» program.

«The «Pharma-2030» program is different from the current «Pharma-2020» program. The task of the latter was import substitution for vital and essential drugs» — said the Director of FSI «SID & GP» Mr. Vladislav Shestakov. «The «Pharma-2030» program includes evolvement of such areas as innovative breakthrough technologies, personalized medicine, biomedical cell-based products, full-cycle manufacture of APIs, and growth of export capacity of the country. Today, the products of local manufacture are being registered and supplied to more than 60 countries globally.»

To translate these plans into action, the Institute maintains close collaboration with foreign pharmaceutical companies, international unions and associations, and actively implements both its own and partnership educational programs for Russian GMP inspectors. Thus, the plan is to develop a project on the virtual site, which is an interactive system for training of inspectors using virtual reality technologies. In response to this, the colleagues from GE Healthcare Life Sciences told about a similar solution for touring a modular site (KUBio) intended for manufacture of monoclonal antibodies, where the manufacturing line is based on disposable technologies. They expressed their eagerness to share the experience of developing such projects.

The GE Healthcare Life Sciences company has been implementing the programs in support of developers, pharmaceutical companies, and doctors who are involved in research and manufacture of biopharmaceuticals (anti-tumor products, vaccines, therapeutic proteins, etc.). Being a part of GE Healthcare, the Life Sciences subdivision acts as a partner of private and state-owned companies, as well as international pharmaceutical corporations with the aim to develop pharmaceutical manufacture in different countries all over the world, and also cooperates with them in localization of manufacture of their products.

Within the meeting, a workshop on the topic «A regulatory review of the disposable and the traditional technology of manufacture of biopharmaceuticals» was arranged. During the workshop, the attendees were presented the benefits and specific characteristics of the disposable technology

for manufacture of biopharmaceuticals. The disposable, the traditional and the hybrid technologies were compared. Moreover, the regulatory legal framework in terms of disposable technologies from the risk assessment point of view was discussed.

To conclude the meeting, Mr. Parrish Galliher, Chief Technology Officer, Upstream Bioprocessing, GE Healthcare Life Sciences, highlighted that the experience of FSI “SID & GP” in professional education and advance training of the staff of the Russian GMP inspectorate is unrivaled throughout the world and expressed his hope that the Russian office of GE Healthcare Life Sciences may count on future cooperation within educational projects.

At the meeting, the FSI «SID & GP» was presented by the Director Mr. Vladislav Shestakov, Deputy Director for Scientific Issues Mr. Illarion Boyko, Head of the Administration for Inspections of Drug Manufacturers and Expert Evaluation Ms. Nataliya Chadova, Advisor to Director and Educational Programs Manager Ms. Victoria Gortinskaya, and representatives of the Department of Drug Manufacture Inspections. From the GE Healthcare Life Sciences side, the meeting was attended by Chief Technology Officer, Upstream Bioprocessing, GE Healthcare Life Sciences Mr. Parrish Galliher, Strategic Projects Manager Mr. Jeffrey Carter, General Director Mr. Andrey Demurin, Product Marketing Regional Manager for Russia/CIS, Middle East and Africa Ms. Olga Bogonina, Head of Accounts Department Ms. Liya Berezkina, Bioprocess Division Manager Mr. Oleg Karpovich, and Marketing Specialist Ms. Yuliya Melnikova.