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BioCentrum obtains a Certificate of Good Laboratory Practice (GLP)
Thursday, 19 May 2011

On 19 May 2011, BioCentrum, part of the Selvita Group, received a certificate of compliance with the principles of Good Laboratory Practice (GLP). The certificate was awarded after a successfully completed verification by the Bureau for Chemical Substances (institution of governmental administration granting GLP certificates) .

 

GLP Certificate No 3/2011/DPL covers all the activities of the BioCentrum’s Cell Laboratory, including analytical and clinical chemistry testing, as well as in vitro tests in the area of cytotoxicity of chemical substances. This certificate has been issued for an indefinite period of time, however its subject to compulsory re-certification in 2 years from the date of the issue.

 

GLP certification marks a very important step in the company’s development. It provides evidence that the services offered by BioCentrum are performed with the highest quality standards and requirements set by the industry, as well as it shows that BioCentrum possesses adequate facilities and equipment, as well as employs a team of professionals who guarantee the highest standards of quality in all performed work.

 

"GLP Certification is an extremely important stage in the development of our company. This certification is an indication that all the services and research done by us in the field of cell and molecular biology are conducted in accordance with the highest international standards of Good Laboratory Practice. This certification is also a confirmation that our standards of work in the laboratory are identical with those of the finest laboratories in the world. Since the very beginning of BioCentrum we’ve been striving to deliver our customers with the highest quality of services, GLP certification is a confirmation that we’ve been able to achieve that. " – said Dr Milosz Gruca, BioCentrum’s R&D Director and Member of the Board.

 

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc....GLP was instituted as a standard meant to ensure the quality, integrity, and reliability of safety data.


BioCentrum is a privately-owned biotechnology service and product provider from Kraków, Poland and is a part of Selvita group since 2008. The company was established in 2004 and its mission is to create a platform for its clients and partners in order to help them translate innovative discoveries into preclinical candidates with improved chances to reach the market, in the shortest amount of time possible.

BioCentrum is active in several areas of life science and offers a following range of services:

-          In vitro preclinical development services, which include the key steps in the process of drug development, used in the pharmaceutical and biopharmaceutical industry.

-          In vitro assay development, working primarily on ELISA and cytotoxicity assays. We execute spectrophotometric, fluorescence, fluorescence anisotrophy and chemiluminescence measurements, as well as we perform cell cycle arrest analysis and apoptosis/necrosis identification in the area of fluorescence analysis.

-          Highly specialized services in analytical and physicochemical chemistry, aimed at the companies from pharmaceutical industry

-          REACH analytical services

-          Services in the field of protein chemistry, covering a wide range of standard and advanced analysis, as well as the production and purification of proteins.

-          Production of highly purified and highly active enzymes, inhibitors and other biologically active recombinant proteins.

The laboratory is fully integrated with STARLIMS laboratory information management system both for control of the analytical equipment and for data reporting and processing. Since 2010, BioCentrum’s laboratory is certified with the General Pharmaceutical Inspectorate certificate, in the field of therapeutical substance manufacturing for the physicochemical analyses of the substances and their certification, as well as with the GLP certificate for the analytical and clinical chemistry testing, and in vitro tests in the area of cytotoxicity of chemical substances.

 

Media contact:

Natalia Pawela

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+48 784 069 418 

 

 

 

 

 

 


 

 
BioCentrum will perform crystallography studies for the Institute of Biotechnology and Antibiotics
Monday, 04 April 2011
BioCentrum (Selvita Group) and the Institute of Biotechnology and Antibiotics announced commencement of cooperation concerning conduction of crystallography studies as an element of preparation of the registration dossier for a medicinal product. 

Institute of Biotechnology and Antibiotics as a coordinator of the consortium of several Polish academic institutions, aiming at the development of technology and conduction of preclinical studies testing  the properties of recombinant human insulin analogues with a modified hypoglycaemic effect, decided to entrust BioCentrum (Selvita Group) with the crystallographic studies required to determine the spatial structure of chosen insulin analogues. 

Scope of this project, includes development of methods for creation of insulin analogues crystals with the quality suitable for crystallographic measurements, tests using X-ray crystallography to determine the spatial structure of the analogues with atomic resolution, and a detailed analysis of the obtained structural models as well as for the development of a detailed documentation. 

We appreciate the possibility of strengthening our cooperation with such renowned research institute as the Institute of Biotechnology and Antibiotics. We are very pleased that IBA has a  high opinion of their cooperation with the Selvita Group and has trusted us with another project. We believe that the unique capabilities of our dedicated protein biochemistry and crystallography teams will provide the highest quality of work which is to be conducted in this project - said Dr. Milosz Gruca, Director of Research and Development, Board Member of BioCentrum. 

Entrusting Selvita Group with this project, we’ve guaranteed ourselves services of an experienced  team that has the appropriate research facilities, scientific knowledge and the ability to work in accordance with the international quality standards of R&D. With such partner by our side, who approaches the tasks in our project with competence and full commitment , we are confident that we will achieve the intended goals - said Bożena Tejchman-Małecka, Head of the Department of Chemical Analysis at the Institute of Biotechnology and Antibiotics. 

The project covered by this agreement will be conducted in a way that all the results and prepared documentation will be available for direct use for the registration of a medicinal product by the entity implementing the project. 

All tests performed by BioCentrum will be carried out in accordance with the regulations of the Polish and European pharmaceutical law, as well as according to the directives of the European Medicines Agency.





Selvita Group is an innovative Polish company providing research and development services and IT solutions. We deliver comprehensive solutions for pharmaceutical and research companies targeted at lowering the cost of bringing products to market. The group also includes BioCentrum, which has been audited and qualified by the General Pharmaceutical Inspectorate in the field of therapeutical substance manufacturing for the physicochemical analyses of the substances and their certification.  BioCentrum’s offer includes services in chemical analysis (eg. development, validation and transfer of methods of API analysis, stability testing, dissolution profiles), protein chemistry (incl. analysis of amino acid composition and sequencing), in vitro preclinical studies (ADME) crystallography, and enzyme production. 

The Institute of Biotechnology and Antibiotics (IBA) is a state-owned research and development organization established in 1985 by the Minister of Industry. The IBA operates in the health service and pharmaceutical sector. It employs 151 people, including 34 research scientists. The IBA’s mission is to conduct scientific research in biotechnology, and the development and implementation of antibiotic technology and other biologically active substances; strengthening, and improving the image and position of the IBA within the scientific communities and in the pharmaceutical sector; as well as to disseminate the quality assurance policy for IBA operations.



Media Contact: 
Natalia Pawela 
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tel: +48 784 069 418 

 
BioCentrum participates in the BioPh Europe conference
Wednesday, 14 July 2010
Place: 5th - 7th October 2010, Nord Villepinte, Paris, France

BioCentrum will participate in one of the greatest pharmaceutical events this year. Newly launched  in 2009 at Feria de Madrid, Spain - BioPh is all about companies and organizations dealing with the research and development of new treatment methods made through biotechnological processes or which are derived from or use live organisms. These companies will once again benefit from the mix of exhibition and seminars and at BioPh Europe 2010.

BioCentrum will exhibit during this event. We cordially invite you to visit us at the booth 4BIO40.

To contact BioCentrum's delegates at this conference please write to: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

 
Adamed teams up with BioCentrum to develop innovative oncological drug
Friday, 27 November 2009
Adamed, the leading Polish producer of pharmaceuticals, and BioCentrum,  a provider of contract pharma & biotech R&D services, initiated  a joint project to develop an innovative oncology drug.

Warsaw, 24 November 2009 - Adamed and BioCentrum announced today launch of a new research project, which may have a significant impact on the development of the Polish pharmaceutical sector. The aim of this joint project is to develop an innovative oncology drug. 
The initial phase of research involves mainly identification and structural characterization of new molecules, inhibitors of one of the major pathways of proteins involved in the process of oncogenesis.  The second phase of the project will involve Adamed performing clinical trials of the potential drug.
Research will be mainly based on the use of latest-generation analytical methods. Tasks scheduled include advanced computationally-aided compound development supported by calculations, method development for the synthesis of chemically isolated compounds, an innovative process of in vitro screening of compounds with advanced biochemical assays, lead optimization using computational methods, crystallography and  animal studies.

The final outcome of this project has a chance to become the first cancer therapy in the world which uses this particular protein target. Potentially, as many as three million patients worldwide would be able to benefit from this treatment. It is presumed that the phase I clinical trials could begin in 2013.

 "I must admit that the research project which Adamed is developing in a collaboration with Biocentrum, is an opportunity to begin a new era in Polish and global medicine. We are talking about new targeted therapy, where the therapeutic molecule is acting directly on the tumor, destroying only cancer cells, and sparing healthy tissues of the body. Collaboration with BioCentrum enables us to consolidate our knowledge in the field of innovation, with the involvement of scientists and the latest laboratory tools for cancer research. The aim is to strengthen our capabilities in conducting research and development which could lead to invention of a new oncology therapy. I hope that collaboration with BioCentrum will contribute to the development of an innovative drug that will meet the needs of cancer patients” - said Małgorzata Korpusik, Adamed’s Board Member responsible for Research, Development and Manufacturing.

The project also involves participation of Faculty of Biochemistry, Biophysics and Biotechnology of the Jagiellonian University as well as the biotechnology company Selvita, BioCentrum’s strategic investor.
"We feel honoured that Adamed decided to conduct the project proposed by BioCentrum and the Jagiellonian University. A partner with the largest experience in preclinical development in Poland,  and a great scientific potential, will allow to employ all the ideas the BioCentrum’s team has."- said Paweł Przewięźlikowski , BioCentrum’s CEO,  “working with Adamed will enable us to take a full advantage of our new laboratory and the research methods which have been implemented.”

BioCentrum  is a private company operating in the area of biotechnology.  BioCentrum's mission is to create a platform for its clients and partners in order to help them translate innovative discoveries into preclinical candidates with improved chances to become marketed in the least amount of time possible. The company offers custom services in the area of preclinical studies, including the key steps in the process of drug development that are used in the pharmaceutical industry and biotechnology. The company also provides services in the field of protein chemistry, covering a wide range of standard and advanced analysis, as well as the production and purification of proteins. Using extensive research experience of its employees, BioCentrum works on the research and development projects within a wide range of topics of modern biotechnology. BioCentrum also has in its offer a panel of highly-purified and highly-active enzymes, inhibitors and other biologically active preparations of their own production.

Adamed is a leader on the Polish market for a new generation of drugs in multiple therapeutic areas including cardiology, psychiatry, pulmonology, gynaecology and treatment of urinary tract infections. Adamed owns two large drug-producing plants: in Pienkow near Warsaw, and Ksawerow in the Łódź Special Economic Zone.  Adamed’s mission is to search for new therapies for the treatment of the “civilization diseases” such as hypertension, diabetes, obesity, and cancer. Adamed is intensively developing its research departments, investing in new laboratory equipment and training Polish scientists. In the past five years spending on research and development of the company reached over 150 million PLN. At that time the company  has patented more than 20 formulas of own medicines. Adamed which has a 100% Polish capital, was founded in 1986. Function of the President of Board is served by Maciej Adamkiewicz.
 
New whitepaper on Pre-clinical outsourcing to Poland
Friday, 05 December 2008
Over the last decade outsourcing has become an important strategic issue for pharmaceutical companies. Rising pressure to reduce costs and time-to-market has led to outsourcing not only of traditional non-core functions such as manufacturing and clinical trials, but also increasingly of preclinical studies and drug discovery activities. Since the expansion of the European Union, established pharma companies are looking more and more into services of the outsourcing companies from Eastern Europe. Eastern Europe possesses one of the most established and expanding infrastructures for research outsourcing. One of the countries worth paying special attention to is Poland, and particularly a city located in the South of country – Krakow, the scientific capital of Poland.
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