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Polpharma has established cooperation with Pikralida, a biopharmaceutical start-up that is working on a breakthrough therapeutic solution to protect against the development of epilepsy after a traumatic brain injury or stroke.

The cooperation involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial. The manufacturing process will be conducted by Polpharma, in accordance with the Good Manufacturing Practice (GMP) standards.

In cooperation with the M. Nencki Institute of Experimental Biology, Pikralida is working on a breakthrough therapy that protects against the development of epilepsy after a brain injury or stroke. The project is based on the results of years-long research on the role of MMP-9 enzyme in the development of the epileptogenesis process. The research has been conducted under the supervision of prof. Leszek Kaczmarek, head of the Laboratory of Neurobiology of the Institute of Experimental Biology M. Nencki PAN.

We are working intensively on the preparation of our clinical candidate PKL-021 for the Phase I clinical trial. One of the extremely important elements of the project, at the same time limiting its progress, is the availability of the drug substance. The Pikralida Process Chemistry team has developed an efficient synthesis process for PKL-021. We have decided to entrust the manufacturing of the drug substance according to the cGMP standard to Polpharma S.A., which has a team of qualified specialists with extensive experience in the production of active substances in the GMP standard. We are convinced that our project is in the hands of the best specialists in the country, and that the tested substance will meet the stringent standards set by the European regulatory authorities – says Dr. Stanislaw Pikul, President at Pikralida sp. z o.o.

Thanks to the extensive experience of our API team in the development of chemical processes and their scaling and production under cGMP conditions, we are supporting our customers and partners, innovative companies, at every stage of the development of drug candidates, from API supplies for preclinical studies to validation, commercial launch, and full life cycle management. We are glad that we will cooperate with a group of specialists from Pikralida who have developed a technology that we will be able to transfer to Polpharma in order to produce the active substance for the project.

Using the best knowledge and competence of our specialists in active substances and our state-of-the-art facilities, we will provide Pikralida with a seamless platform to support their clinical trial program, which we all hope will finally result in breakthrough therapy to prevent the development of epilepsy – says Sebastian Szymanek, President of the Management Board of Zaklady Farmaceutyczne Polpharma S.A.

Pikralida sp. z o.o. is a biopharmaceutical start-up developing a portfolio of R&D projects involving therapeutic solutions based on innovative small-molecule substances, innovative formulations of combination drugs, and state-of-the-art drug delivery systems.

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Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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