Cluster

PharmValley

Full cycle (development, preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form) of works and services necessary for the creation of medical applications for the pharmaceutical industry in accordance with international standards of good practices (GLP, GCP, and GMP).

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Cluster specializations

Development of innovative capacity and research and development sector

service 3

Pharmaceutics

service 1

Medical industry

service 2

New material

service 3

Industrial biotechnology

Main product


Development, conducting preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form and other services necessary for the creation of drugs and medical products.

The purpose of the Association of cluster members


Full cycle (development, preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form) of works and services necessary for the creation of medical applications for the pharmaceutical industry in accordance with international standards of good practices (GLP, GCP, and GMP). Creation of pilot production of medicines on the basis of sites of the Moscow Institute of Physics and Technology and research Centers of RAS in Chernogolovka and G. Pushchino and a number of other scientific institutions for the biopharmaceutical industry in accordance with international standards (GxP).

Cluster development priorities

  • organizational development of the cluster and strengthening of cooperation between the participants
  • development of innovative capacity and R & d sector
  • development of production capacity and expansion of market share of products and services of cluster members
  • human resources development
  • Formation of a common brand and raising awareness of the cluster
  • Development of international cooperation
  • Development of relations with authorities

The members of the cluster


Центр Доклинических Испытаний

PCSC

АдресМосковская область, г. Пущино, Проспект Науки д.3, офис 409

ЦДКИ сервисная организация, выполняет функции Проектного Офиса кластера, включая связи с СМИ, анализ рынка и маркетинг, привлечение заказчика, осуществляет необходимые для исследования закупки - реактивы, расходники и т.д., ведет процедуры таможенного декларирования и логистики биообразцов и исследуемых препаратов, оказывает регуляторную поддержку, проводит оценку необходимого объёма исследований, разработку и написание медицинской документации, поддерживает аккредитацию тестовых площадок.

project 2

ФГБНУ "Научно-исследовательский институт медицинской приматологии"

Адресг.Сочи, Адлерский р-он, с.Весёлое, ул.Мира, д.177

НИИ МП Институт является единственным приматологическим центром России и крупнейшим в Европе. Институт располагает Лабораторией молекулярной биологии и генетики; Лабораторией токсикологии с отделом патоморфологии и морфометрии; Лабораторией биохимических исследований; Лабораторией канцерогенеза; Лабораторией фармакологии и физиологии; Химико-аналитический отдел; Лабораторией микробиологии вирусологии с отделом иммунотоксичности и аллергенности; Лабораторией молекулярной визуализации; Лабораторией клеточных технологий с отделом цитотоксикологии; Лабораторией эмбриогенеза и Питомником обезьян с отделом стадо SPF и биологических моделей.

project 3

ЗАО "БИС" Биологические исследования и системы

АдресМосковская область, Пущино, Институтская, д.3

ЗАО «БИС» ("Биологические исследования и системы") производственная фармацевтическая компания. Компания с 2013 года имеет сертификат GMP и специализируется на производстве лекарственных средств, фармацевтических субстанций, получаемых методом химического синтеза. Номенклатура продуктов включает 10 наименований АФС и ГЛФ лекарственных препаратов включая Деквалиния хлорид, Мезодиэтилэтилендибензолсульфонат, Сибутрамин, Повидон-Йод, Празозин, Трийодрезорцин, Гидроксифенилпропионовая кислота+Гидрокоричная кислота, Селена сульфид и Пипофезин.

project 4

«БТех Лаборатории Рус»

«БТех Лаборатории Рус» научно-исследовательская компания. Компетенции компании включают: Синтез и анализ фармацевтических субстанций (ФС) и готовых лекарственных форм (ГЛФ) включая методы синтеза, физико-химические свойства, активность и токсичность in vitro. Патогенетическая оценка заболеваний, фармако-геномика и биомаркеры. Фармакологическая коррекции заболеваний: био-информатика терапевтических эффектов, средства доставки ЛС, изменение характерного фенотипического признака заболевания. Скрининг биоактивности: обратный виртуальный скрининг, фармако-транскриптомный и -протеомный анализ, безопасность модуляции активности мишени, перепрофилирование ЛС.

project 5

Test Laboratory

Test Laboratory “Test” is specialized on laboratory quality control of products and services including tests of food products, animal feeds, production raw materials, water for safety and quality values; Veterinary diagnostics; Studies (development of test systems for microtoxin analysis); Development and implementation of analytical methods; Training and consultations on laboratory arrangements; Production of reference samples.

project 6

ISMAR

ISMAR – the dynamic, multiprofile, private contract research organization (CRO), provides expert services to pharmaceutical and biotechnological companies in development and arrangement of II-IV phase drug clinical studies in Russia, Ukraine and other CIS countries. Clinical studies are carried out in accordance with ICH GCP in therapeutic areas: pulmonology, cardiology, gastroenterology, oncology, neurology, hematology, dermatology, otolaryngology, pediatrics, orthopedics, metabolism disorders/endocrinology, autoimmune diseases.

project 7

The Pushchino State Institute of Natural Sciences

The Pushchino State Institute of Natural Sciences prepares specialists in fundamental and applied biotechnology: - Development of new drugs and their manufacture technologies. Preclinical toxicological studies of safety of biomedical drugs in accordance with the international GLP standard and investigation of their pharmacological action

project 8

The Clinical Site at the Hospital of the Pushchino Research Center

The Clinical Site at the Hospital of the Pushchino Research Center is accredited for I-IV phase clinical studies to establish safety and tolerability of drugs in healthy volunteers; to select optimum drug dosages and courses, and vaccination schemes in healthy volunteers; to establish safety and efficacy of drugs in patients; to expand indications for medical use, and take part in scientific work on development, justification and assessment of efficacy of available and innovative drugs. The Site has the designated unit for 20-45 beds, base of healthy volunteers and full-time medical personnel certified in compliance with ICH GCP R2.

project 9

The Clinical site at the Hospital of the Pushchino Research Center

The Clinical site at the Hospital of the Pushchino Research Center is accredited on III-IV phase clinical studies to establish safety and efficacy of drugs in patients; to expand indications for medical use, and takes parts in scientific work on development, justification and assessment of efficacy of available and innovative drugs. The site personnel consists of 480 highly professional specialists.

project 10

The Institute of Medical Primatology

The Research Institute of Medical Primatology is the sole primatology center in Russia and the largest one in Europe. The Institute has the Laboratory of molecular biology and genetics; Laboratory of toxicology with the pathomorphology and morphometry department; Laboratory of Biochemical Studies; Laboratory of Cancerogenesis; Laboratory of pharmacology and physiology; Chemical-analytical department; Laboratory of virology microbiology with the immunotoxicity and allergenicity department; Laboratory of molecular visualization; Laboratory of cell technologies with the cytotoxicology department; Laboratory of embryogenesis and Monkey nursery with the department of SPF animal stock and biological models.

project 11

The Institute of Theoretical and Experimental Biophysics

The Institute of Theoretical and Experimental Biophysics carries out fundamental and applied studies in theoretical and experimental biophysics. Nowadays, the institute consists of 23 laboratories in the areas – Structure and functions of biomolecules and supramolecular complexes, proteomics, catalysis; Cell biology, theoretical fundamentals of cell technologies; Biophysics, radiobiology, mathematical models in biology, bioinformatics and Biotechnology. Generation of tissue engineering biomaterials, diagnostic biological microchips, 3D printing are the priorities.

project 12

The Institute of Problems of Chemical Physics

The Institute of Problems of Chemical Physics operates with 10 research departments, 80 laboratories and scientific groups in which over 1100 persons work including 6 RAS academicians, 3 corresponding members of RAS, as well 109 Doctors and 288 Candidates of Sciences. The works are made in the Institute in the following main areas: general problems of chemical physics, structure of molecules and structure of solid bodies, kinetics and mechanism of complex chemical reactions, chemical physics of combustion and explosion, chemical physics of polymer formation and modification processes, chemical physics of biological processes and systems, chemical material engineering.

project 13

The Institute of Physiologically Active Substances

The Institute of Physiologically Active Substances carries out the entire complex of studies on development of physiologically active compounds, from computer modeling of structures and properties of chemical compounds to their synthesis and investigation of biological properties. The Institute has three specialized divisions: department of the computer molecular design, department of the fundamental organic chemistry, department of medical and biological chemistry including areas – Synthetic organic and element organic chemistry; Investigation of biological properties of chemical substances and mechanisms of their exposure on functioning of biological systems and Computer molecular design. Numerous research and development works by IPAS have been widely acknowledged both in Russia and abroad.

project 14

The Institute of Bioorganic Chemistry

The Institute of Bioorganic Chemistry develops and manufactures the most advanced drugs of protein origin and generates various types of agricultural biotechnology and biofarming based on transgenic plants. The institute has the complex of unique divisions: Laboratory of biological tests, Research and Production Enterprise “Nursery for Laboratory Animals” and the Complex of fire waste disposal. Since 2005, the Laboratory has been accredited by AAALACi, since 2013 has been internationally acknowledged as compliant with GLP OECD, since 2017, the Laboratory is the partner of JSC “Russian Expert Center”. The nursery has been accredited by AALACi since 2004, ISO 9001 since 2007.

project 15

The Institute of Biochemistry and Physiology of Microorganisms

The Institute of Biochemistry and Physiology of Microorganisms carries out fundamental and applied studies on microorganism structure and functions including – Research of fine structure and biochemical functions of a microbial cell; Development of theoretical fundamentals of growth management, development and metabolism in microorganisms; Microbiological transformation of organic substances (steroids, amino acids, etc.); Use of microorganisms for biosynthesis of biologically active substances and other essential compounds (vitamins, enzymes, antibiotics, alkaloids, etc.) and Collection of the microbial variety.

Specialized organization of the cluster PharmValley is PCSC


PCSC service organization, performs the functions of the project office of the cluster, including media relations, market analysis and marketing, attracting the customer, carries out the necessary research purchases - reagents, consumables, etc., conducts customs Declaration procedures and logistics of biological samples and studied drugs, provides regulatory support, evaluates the required amount of research, development and writing of medical documentation, supports the accreditation of test sites.

Certificates


Contact


Write to us

Name
Email
Message

142290, Moscow region, Pushchino, prospect Nauki d. 3, office 409

info@pharmvalley.ru

+7 (916) 226 25 48