Establishing a Pilot Center for Bioinformatics

Project tasks

The key tasks of this project are:

• To establish high-tech pilot production with a flexible technological process flow principle, allowing parallel manufacture of different kinds of products and fast switchover  to manufacture of new products;
• To prepare a package of documents and obtaining licensing for production in accordance with the GMP standard, including certification of the engineering and technological systems.

 

Project participants

• Institute of Chemical Biology and Fundamental Medicine (ICBFM), Siberian branch of the Russian Academy of Sciences
• LLC Biosan
• CJSC MBS-Tehnologiya

 

Market potential

Currently there are few anti-cancer protein pharmaceuticals in the market. The available pharmaceuticals of the peptide nature are very costly and have serious by-effects, which limit their use. Each new development in this field provides unquestionable competitive advantages to its producer. The technology of producing an antitumor pharmaceutical agent designed for treating breast cancer has been developed in ICBFM.

The production facility being established will become a unique component of the innovations infrastructure of the Novosibirsk region. Project implementation will accelerate commercialization of the perspective developments by the research institute’s scientists in the area of innovative pharmaceuticals and will allow certain social and economic constraints to be resolved.  

Development of the theoretical base and experimental testing of the new pharmaceuticals and treatment methods will allow the cancer treatment therapy to be improved due to the use of state-of-the-art achievements and innovations.

Provided full workload of the production unit, it will be able to produce about 50 kg of pharmaceuticals per year. Such production volume will allow the enterprise fully to meet the Russian demand. The products’ compliance with the GMP standards will allow the company to enter the foreign markets (Europe, Japan, Ukraine, and USA).

 

Topicality

Due to funding of target programs (in the framework of the Pharma 2020 strategy and the Rosnano projects), the number of innovative biopharmaceuticals will grow. However, the country lacks specialized infrastructure facilities, which would contribute to their commercialization. The pilot biopharmaceutical center is a strategically important infrastructure project, which is supposed to ensure implementation of a new innovative economy in the area of the Russian health care system.

Project phase

A joint venture has been established to implement the project, the first batch of equipment has been supplied, premises and documentation are being prepared for production.

 

Theimplementationandfundingplan

 

Project phase	Implementation period (duration)	Result	Funding, thousand rubles
Procurement of equipment	July2014- December2016	protocol of assembly and commissioning works	76,530
Preparation of premises, installation of engineering systems	January2015- December2016	report on validation of qualifications required for upgrading the premises, protocol of equipment installation works	6,800
Staff training	January2016-December 2016	training certificate
Try-out of the technological process, production of pilot lots of pharmaceuticals	January2016-December2016	pilot lots of pharmaceuticals
Developing documentation for the quality management system	July2015-June2016	documentation	3,000
Equipment certification, pre-certification GMP audit	January2016-December2016	certificationprotocol, auditreport	1,800
Conducting market studies, developing a business plan	January2016-December2016	market study report, business-plan
Total			88,130

 

Required support of the cluster infrastructure

• Developing a business plan and presentation materials;
• Communication activities;
• Attracting potential customers;
• Lobbying the project;
• Obtaining finance.