Certificate of Suitability (CEP) for Tacalcitol

Obtaining a CEP for an active substance was preceded by a lengthy authentication process. Łukasiewicz – IChP is so far the only manufacturer in the world that has received this certificate for API Tacalcitol, used in medicinal products indicated for the treatment of dermatological diseases. We are very proud of our achievement, we worked hard to have it!

Lukasiewicz – ICI produces active pharmaceutical ingredients (APIs) in several therapeutic areas: oncology (imatinib, sunitinib, anastrozole), vitamin D metabolites (alfacalcidol, tacalcitol and others), cardiology (carvedilol, clopidogrel), ophthalmics (latanoprost, brinzolamide), antipsychotics (olanzapine) in original polymorphic form and many other APIs for which it has ready-to-implement technologies.

– It took a great deal of effort and commitment on the part of our team to obtain CEP certification for Tacalcitol,” says Wojciech Maszewski, director of the Pharmaceutical Products Department at Lukasiewicz – ICI, and adds: – This synthesis is extremely complicated and time-consuming, and like other API syntheses, we have to perform it under a strict regime of GMP requirements. In addition, all analytics and product documentation had to be verified with the European EDQM agency, which was difficult and often kept us awake at night, but in the end we succeeded! We are very proud of this. As a result, firstly, we have confirmed the quality of our work in the highest European standards, and secondly, our customers – manufacturers of drugs produced on the basis of our Tacalcitol – have a tremendously simplified registration path, which saves them time and significantly reduces their costs.

I.L.-W.

An innovative idea in 15 days

It takes no more than 15 working days for a group of 4,500 scientists from the Łukasiewicz Research Network to face a business challenge and propose effective implementation solutions. The scientists of Łukasiewicz are able to propose a R&D project as quickly as never before to improve the entrepreneur’s activities. Most importantly — the entrepreneur won’t bear any costs related to the development of an idea for research.

— The Łukasiewicz Research Network was established to be the shortest path between business and science. “The shortest” means the minimum effort for the entrepreneur who comes to learn for support, and the shortest possible time for science to respond to business challenges. Time in business is crucial. Nowadays, in demanding business conditions it can be crucial for the success of the undertaking. That is why Łukasiewicz acts in such a way as to minimize the entrepreneur’s effort to maximize his potential benefits from research and development cooperation — says Piotr Dardziński, President of the Łukasiewicz Research Network.

The model of “challenging” the scientists from Łukasiewicz has been in operation since November 15, 2019. So far, Łukasiewicz has responded to 43 business challenges reported by companies by presenting 331 ideas for research and development. From April 1, 2020, a form is available on the website that streamlines and speeds up the process. Those interested in innovation, supporting their business, introducing a new product to the market or developing their business describe their problem/business challenge and the expected scope of support for scientists at https://lukasiewicz.gov.pl/biznes/ and send it to the Łukasiewicz Centre.

The Łukasiewicz Research Network engages its resources: the highest competences of scientists in Poland and scientific equipment unique on a national scale to meet the business needs of the entrepreneur. After internal works, panels, generating ideas and their evaluation, he presents entrepreneurs in a convenient way and on a set date with the best ideas for supporting his business.

Łukasiewicz’s potential focuses on the directions influencing the achievement of the objectives of the Strategy for Responsible Development. There are four Research Groups in Łukasiewicz specializing in such priority research areas as: Health, Smart Mobility, Digital Transformation and sustainable economy and energy.


 

Polish scientists are getting closer to an effective drug for COVID-19

A team of Polish scientists from Łukasiewicz – Industrial Chemistry Institute and Wrocław University of Technology, in cooperation with the laboratories of Rolf Hilgenfeld (Lubeck) and Shaun Olsen (San Antonio), identified molecules with great therapeutic potential that could be a breakthrough in finding an effective drug against COVID-19. Thanks to research conducted under the supervision of Prof. Drąga from the Wrocław University of Science and Technology managed to identify molecules whose action may be even better than that of ebselene – a known anti-inflammatory drug, which in previous studies turned out to be a promising inhibitory substance (inhibitor) of both SARS-CoV-2 proteases. The COVID-19-causing coronavirus has two proteases, or enzymes. The aim of the The project “Research on a vaccine against the SARS-CoV-2 virus and support for research work on the search for an effective therapy” is precisely the inhibition of the enzyme, which will prevent the spread of the virus. – Our research on close structural analogs of this drug allowed to identify even better than ebselene molecules, both for Mpro and PLpro proteases. What’s more, these compounds are excellent inhibitors of both viral proteases, so their therapeutic potential is definitely more promising – explains Prof. Drąg from the Wrocław University of Technology. Research currently conducted by prof. Drąg was preceded by the preparation of an active and functional Mpro protease, which was undertaken by a team led by dr hab. Małgorzata Kęsik-Brodacka from Łukasiewicz – Institute of Industrial Chemistry. – The discovery is a promising platform for the development of new antiviral drugs targeting both SARS-CoV-2 proteases – emphasizes Dr. Małgorzata Kęsik-Brodacka from Łukasiewicz – IChP. Completion of the project is planned for the end of October this year. The direction of further research will depend on the results of intensive work. Research work is financed, inter alia, from the fund of the Medical Research Agency.


International Women’s Day in Science

 

On February 11, we celebrate the International Day of Women and Girls in Science. On this occasion, we asked three women scientists from the Łukasiewicz Research Network about their professional path and what brings them shorter working time in scientific work. We were also curious to know what advice they have for new young people who are still starting their career, and – perhaps – are afraid of obstacles, while looking for answers to the path of a scientific career. As we know, the career of a scientist – women certainly requires more work … But let us give our ladies a voice. In a short video speech: Dr. Róża Szweda (Łukasiewicz – PORT), Dr. hab. Małgorzata Kęsik-Brodacka (Łukasiewicz – IChP) and dr hab. Eng. Agata Jasik (Łukasiewicz – IMiF).

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