Alexey Pavlov, Director of the Department of Quality Management at NANOLEK, took part in the round table discussion "Specifics of the production of immunobiological drugs", held as part of the V All-Russian GMP conference.
The thematic event was moderated by Elena Denisova (Ministry of Industry and Trade of Russia) and Irina Novikova (GMP news magazine). Following speakers were invited to participate: Elena Makarova (MSD Pharmaceuticals), Stanislav Uyba (Mechnikov Institute), Stanislav Afanasiev (FORT), Mikhail Tsyferov (NPO Petrovax Pharm) and other representatives of pharmaceutical companies.
The colleagues had a chance to discuss the issues of concern: development of production of immunobiological drugs in the Russian Federation and technology transfer, production cooperation, specifics of logistics, experience in inspecting production facilities and examples of cooperation between the Russian and foreign companies. Besides, the participants answered questions asked by the moderators.
Alexey Pavlov shared his experience in localizing the production of the Pentaxime ® vaccine, told about technology transfer, stages of cooperation, quality guarantees, ins and outs of import substitution and important peculiarities of the production of immunobiological drugs.
NANOLEK is implementing this project jointly with its French counterparts from Sanofi Pasteur. The vaccine is included in the National preventive vaccination calendar and protects children from five dangerous infections: diphtheria, tetanus, pertussis, polio, and infections caused by Hemophilus influenzae type B (HIB).
You need to follow a number of regulations before proceeding to work with an international partner: you have to make sure that all requirements of both parties are met, and any contradictions with the legislation of both countries and in-house regulations of each of the companies are ruled out, and the equipment in the production facility is checked thoroughly by an international partner and local regulators. Checks are made at different stages and at all levels, which gives grounds for confidence that the NANOLEK production facility meets high GMP standards.
In his speech Alexey Pavlov emphasized the first-rate importance of the ability to work in a team: "I believe that we have managed to create a highly effective team of highly qualified professionals - one for both companies - which gives us an opportunity to move gradually forward, towards achieving our common goals set at the very beginning of this long and fruitful path. The success of any project depends on how professionally, carefully and systematically both parties will deal with solving these issues. If every participant understands the significance of their job and importance of their contribution to the common cause, if everyone realizes what targets we should strive for, and what benefits they will bring to the whole society, then such an undertaking will be guaranteed success."
