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Focus on customer needs yields outcomes when developing a new drug

Acute pulmonary hypertension, or high blood pressure in the lungs' pulmonary arteries, is a life-threatening condition that can develop in a variety of serious illnesses. The technology of Attgeno, a Swedish pharmaceutical business, is based on Karolinska Institutet's groundbreaking research on nitric oxide and circulatory physiology.

RISE was asked to join as a development partner when the project's development work began in 2017. Attgeno had already produced prototype formulations, but was looking for RISE expertise, notably in CMC (Chemistry Manufacturing and Control), to produce human clinical trial material.

- Having RISE as a development partner has been very beneficial,' says Tuulikki Lindmark, Attgeno's CMC and pharmaceuticals manager. RISE has not only provided specialized expertise but has also improved our grasp of the project's concerns and challenges. We have had a good and close relationship in which we were able to keep all elements and abilities working together.

The fact that nitric oxide (NO) is a chemical created by the body and thus a natural part of our body is a major advantage of pharmacological treatment based on NO. Substances that give NO to the body have long been employed in therapeutic therapies, but they are limited by side effects and problems with tolerance development when they release NO in all regions of the body. Attgeno's first medication candidate, Supernitro (PDNO), is being developed to selectively widen blood arteries in the lungs. Based on the original prototype, RISE was a partner in pharmaceutical development, producing a manufacturing procedure for the active component and formulation, including analytical methods, specifications, quality controls, and descriptions.

- The most important thing for us when we enter a project is to quickly get an idea of ​​what the customer's needs are and how we can support them to make the maximum possible benefit, says Anna Minidis, technical project manager at RISE.

An important part of the assignment has been support in toxicology with making calculations and producing data for degradation products that show that the substance meets regulatory requirements regarding documentation and is safe to use on patients. RISE has a unique opportunity to put together teams with expertise in all the parts required to ensure that a substance meets the requirements for clinical trials.

- RISE has been an integral part of the project, providing invaluable assistance in areas such as understanding how the substance behaves and creating analytical methods, processes, and specifications, explains Tuulikki Lindmark.

When RISE first joined the project five years ago, the goal was to contribute methodologies for the synthesis and analysis of substances and formulations using its pharmaceutical development experience. RISE's role as a strategic partner inside CMC has since been expanded to include process development, additional development of analysis methodologies, regulatory support, and identification of potential manufacturers. On behalf of the company, one of RISE's toxicology and regulatory documentation experts has been tasked with designing and monitoring future toxicological investigations as well as writing associated regulatory paperwork.

Matilda Bäckberg

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Matilda Bäckberg

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