Selvita S.A.

Name: Selvita S.A.
Address: Bobrzyńskiego 14, Kraków, 30-348, PL
Telephone: +48122974700

Integrated Drug Discovery | Drug Development | Contract Research The Company’s research sites are in Krakow (HQ), Poznan, Poland, and Zagreb, Croatia.

Selvita is one of the largest preclinical contract research organizations in Europe, driven by a clear mission: to offer a comprehensive scope of services bridging the gap between early drug discovery and the clinical stage of drug development. Selvita provides comprehensive solutions supporting Clients and their drug discovery projects, across a broad range of therapeutic areas, specializing in i

nfectious diseases, inflammation, fibrosis, and oncology. The Company offers a range of stand-alone or fully integrated drug discovery and development solutions spanning the entire value chain from early drug discovery to preclinical development. On top of that Selvita also offers analytical support of drug development and contract testing studies. Selvita, established in 2007, operates globally with over 900 highly qualified employees, of which over 40% hold a PhD degree. The international offices are located in Cambridge, MA, and San Francisco Bay Area, in the U.S., as well as in Cambridge, UK. Ardigen, a bioinformatics company harnessing advanced Artificial Intelligence methods for novel precision medicine, is part of Selvita Group portfolio of companies. Selvita is listed on the Warsaw Stock Exchange (WSE: SLV).

27/08/2026

When looking alike isn’t enough.

For biosimilar insulin, demonstrating structural similarity is only the beginning.

Insulin biology involves multiple receptor interactions, signaling pathways and biological responses. That’s why functional characterization requires more than a single potency assay.

In our new blog, Justyna Sładowska explores how orthogonal functional assays can build a more complete picture of insulin biosimilarity, from:

• receptor binding and selectivity
• receptor activation and intracellular signaling
• metabolic activity and potency
• safety-relevant responses and product quality

Together, these approaches help connect molecular similarity with biological function and provide the evidence needed to support a robust biosimilarity assessment.

Read Part I of our series: “When Looking Alike Isn’t Enough: Building the Functional Evidence for Insulin Biosimilarity”

https://eu1.hubs.ly/H0xRQvy0

25/08/2026

We’re happy to share a new scientific publication co-authored by our expert Ana Butorac: “Integrative Insights Into Bioactive Peptides in Milk Fermented With Autochthonous and Commercial Cultures Using High-Throughput Peptidomics and Machine Learning.”

The study combines high-throughput peptidomics and machine learning to explore how different starter cultures influence bioactive peptide formation in fermented milk, demonstrating a powerful approach for identifying previously unknown peptides with potentially bioactive properties. The findings highlight the importance of starter culture selection in optimizing bioactive peptide production.

Congratulations to Ana and the entire research team!

Read the full article: https://eu1.hubs.ly/H0xQCJ-0

24/08/2026

Building a formulation without a feasibility study is a bit like planning a road trip using only the destination.

You know where you want to go, you may even have a preferred route.

But until you look at the map, you don't know whether the road is open, how long the journey will take, or what obstacles you'll encounter along the way.

Formulation development works in a similar way.

The desired product profile may be clear from the start, but critical questions often remain unanswered:

• Is the API sufficiently stable?
• Will solubility become a limitation?
• Are there manufacturing constraints?

A feasibility study helps answer these questions before significant resources are invested.

In her latest article, Wiktoria Zych discusses how feasibility studies help teams evaluate risks, challenge assumptions, and build more realistic development strategies.

🔗 https://eu1.hubs.ly/H0xzH-W0

20/08/2026

Another step forward in the development of GENAI-inDD platform at Selvita!
As part of our EU-funded project, we have expanded our peptide synthesis capabilities with the CEM Liberty PRIME 2.0. Equipped with the HT12 and Razor modules, the system enables faster, automated high-throughput peptide synthesis. Combined with AI/ML models developed within GENAI-inDD, it will help shorten the path from computationally generated ideas to their experimental validation.

Following the installation, our team completed hands-on training led by Giorgio Marini from CEM, with support from Rafał Kauca from CEMIS, CEM’s Polish distributor.

Stay tuned for the next developments in GENAI-inDD project!

The project is implemented under the European Funds for a Modern Economy Programme 2021–2027, Action 1.1 FENG – SMART Path.

18/08/2026

𝐖𝐡𝐲 𝐝𝐨 𝐦𝐚𝐜𝐫𝐨𝐜𝐲𝐜𝐥𝐞𝐬 𝐨𝐟𝐭𝐞𝐧 𝐬𝐡𝐨𝐰 𝐮𝐧𝐞𝐱𝐩𝐞𝐜𝐭𝐞𝐝 𝐩𝐫𝐨𝐩𝐞𝐫𝐭𝐢𝐞𝐬 𝐭𝐡𝐚𝐭 𝐜𝐨𝐧𝐯𝐞𝐧𝐭𝐢𝐨𝐧𝐚𝐥 2𝐃 𝐝𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐨𝐫𝐬 𝐟𝐚𝐢𝐥 𝐭𝐨 𝐩𝐫𝐞𝐝𝐢𝐜𝐭?
The answer lies in their three-dimensional structure and conformational behaviour.

In the latest blog article, our expert Sanja Koštrun examines the challenges of characterizing this complex conformational space and demonstrates how NMR and computational modelling can be integrated to generate reliable 3D structures and gain a deeper understanding of interactions with biological targets.

Read the full article: https://eu1.hubs.ly/H0xJf060

12/08/2026

Why a negative result can be good news in formulation development?

Positive results tend to receive the most attention during formulation development. They suggest progress, support further investment, and create confidence in the selected approach.

Yet some of the most important development decisions are driven by results that challenge initial assumptions.

A formulation that fails compatibility testing, an unexpected stability issue, or a prototype that cannot achieve the desired performance may not be the outcome a team hopes for. However, these findings often provide valuable evidence for deciding which development paths should not be pursued further.

Our latest article, by Wiktoria Zych, discusses why negative results are an important part of formulation feasibility studies and how they contribute to more informed development decisions.

🔗 https://eu1.hubs.ly/H0xzyhz0

07/08/2026

🎙️ The new episode of Selvita Science Talks is now available on YouTube and Spotify!

In this episode, we explore two real-world case studies that show how cell-based potency assays are developed for different therapeutic modalities, and why there is no one-size-fits-all approach to bioassay development.

Discover the practical challenges, optimization strategies, and scientific decisions behind building robust, validation-ready potency assays.

🎧 Listen now:
Spotify:https://eu1.hubs.ly/H0xwkKR0
YouTube: https://eu1.hubs.ly/H0xwl6Q0

06/08/2026

Is the formulation concept even viable?

Many of the issues that later become expensive development problems are already present at the beginning of a project. Limited API solubility, sensitivity to moisture, analytical challenges, or manufacturing constraints rarely appear out of nowhere.

More often, they simply haven't been investigated early enough.

In her latest article, Wiktoria Zych, Senior Formulation Specialist at Selvita, discusses how formulation feasibility studies help identify risks, challenge assumptions, and support better development decisions before significant resources are committed.

Read the article to learn:
• What a feasibility study should include
• Why API properties often determine development success
• How early risk assessment reduces costly surprises later
• Why negative results can be some of the most valuable outcomes

🔗 https://eu1.hubs.ly/H0xqJCG0

30/07/2026

What happens when the most important compounds are the ones nobody expected to find?

They often become the most important part of an Extractables & Leachables investigation.

One of the recurring challenges in Extractables & Leachables projects is that the most important compounds are often the ones nobody expected to find.

What did we observe?

In the case studies discussed in our latest article, materials commonly used in pharmaceutical packaging released oligomers, antioxidants, and degradation products that required further investigation before their impact could be assessed.

Why do unexpected compounds matter?

From a CMC perspective, identifying an unknown signal is only the beginning. The real value comes from understanding where the compound originated, whether it can migrate into the drug product, and whether it presents a toxicological concern.

Without understanding the origin and relevance of an unknown compound, analytical data alone cannot support informed CMC decision-making. This is why E&L studies increasingly rely on a combination of study design, high-resolution analytical techniques, and scientific interpretation rather than analytical testing alone.

Read the full article here: https://eu1.hubs.ly/H0xgzpR0

28/07/2026

S*x differences are increasingly recognized as important factors in chronic inflammatory diseases, but their role in epithelial regeneration and tissue repair, particularly in inflammatory bowel disease (IBD), remains poorly understood.

In our latest publication, "S*x differences in secretory and absorptive progenitor cell populations during colon regeneration following dextran sodium sulfate-induced injury", our expert team, together with collaborators from the University of Zagreb, investigated how male and female mice differ in their regenerative response following DSS-induced colonic injury.

The study demonstrates that female mice exhibit earlier stem cell activation, faster epithelial proliferation, and more efficient mucosal healing, while males show delayed recovery, greater dysplasia, and distinct secretory cell progenitor shifts. These findings highlight the importance of considering s*x as a biological variable in preclinical IBD research and may contribute to the development of more effective, s*x-tailored therapeutic strategies.

You can find the publication here: https://eu1.hubs.ly/H0xdZfg0

Adres

Bobrzyńskiego 14
Kraków
30-348

Telefon

+48122974700

Strona Internetowa

http://www.selvita.com/

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