WHEN IT COMES TO HEALTH THERE’S NO ROOM FOR COMPROMISE

Text: Jiří Raška, Chief Commercial Officer and Managing Partner of Quinta-Analytica; Photo: Archive

Every medicine we take goes through a long and complex journey before it reaches the pharmacy shelf. From the first idea in a laboratory to the final pill or injection, each step must guarantee one thing: safety and effectiveness for patients. This is not just a regulatory requirement – it’s a matter of trust and health.

We are racing against time

Medicines are high-end products, and even the smallest mistake can have serious consequences. That’s why rigorous testing and quality control are essential throughout the entire development cycle. It means checking purity, stability, performance, clinical aspects, and ensuring that every dose works exactly as intended. For innovative drugs and their affordable alternatives – generics and biosimilars – these checks are even more critical.

In today’s fast-moving pharmaceutical world, where new therapies like biologics and advanced cancer treatments are emerging, the challenge is bigger than ever. Because when it comes to health, there’s no room for compromise.

Testing the quality of medicines might sound like a boring routine, but in reality it’s full of challenges that sometimes feel like ‘Mission Impossible’. From detecting impurities at incredibly low levels to ensuring complex cancer drugs work exactly as intended, every step requires precision, speed, and creativity. And yet, we make it happen. Why does this matter? Because behind every pill or injection is a race against time to deliver safe, effective treatments to patients. It’s a story of science, responsibility, and determination – far more exciting than it seems at first glance. Let me mention just a few examples that I can speak of from my own experience, and which influenced the lives of many.

COVID-19 experience

When the world faced the COVID-19 pandemic, vaccine makers had to act fast. One of them, Novavax, approached the Quinta-Analytica company to make sure their vaccines were produced quickly and safely.

The collaboration started in 2020, right in the middle of the pandemic. Novavax needed help with complex testing and quality checks for vaccine ingredients. We stepped in, creating and implementing hundreds of testing methods – some from scratch. These tests checked everything from purity and identity to microbiological safety, ensuring every component met strict standards.

Speed was critical. Demand for vaccines was skyrocketing, and Novavax had to scale up production without delays. Turnaround times stayed short, and production kept moving. In fact, by 2022, our lab had tested nearly 6,000 samples of various ingredients – a huge achievement that helped vaccines reach people faster.

The pandemic reminded us how vital vaccines are – and how much teamwork it takes to deliver them. This was one of the biggest projects we are proud to have been part of, helping improve health worldwide.

Cutting-edge cancer treatment made in Czechia

Antibody-drug conjugates (ADCs) are a new generation of cancer treatments that combine two powerful tools: a targeted antibody and a strong chemotherapy drug. The antibody acts like a GPS, guiding the drug directly to cancer cells, reducing harm to healthy tissue and improving patient outcomes.

Creating ADCs is complex because they mix large biological molecules with small chemical ones. Every detail matters – how they’re linked, how stable they are, and how they behave in the body. Ensuring ADCs are of desired quality must happen before they reach patients, of course. Our experts develop advanced testing methods to check these factors, ensuring ADCs are as safe and effective as the manufacturer expects them to be.

What makes this story exciting is that Sotio, an innovative biotech company based in the Czech Republic, is leading the way in developing cutting-edge ADC therapies. The cooperation between Sotio and Quinta-Analytica shows the strength of Czech science and industry: two homegrown companies working together to deliver smarter cancer treatments to the world.

ADCs represent the future of oncology – targeted, precise, and with fewer side effects. Behind the scenes, companies like the aforementioned are proving that Czech innovation can compete globally and make a real difference in healthcare.

The challenge of detecting carcinogenic compounds

In 2019, the pharmaceutical world faced a wake-up call when the U.S. FDA uncovered serious manufacturing process violations at a certain Chinese facility. These lapses led to the unexpected formation of nitrosamines – chemical compounds identified as potential carcinogens. What began as a single investigation quickly grew into a global issue, triggering recalls of widely used drugs like blood pressure medications and heartburn treatments. This incident revealed how even small oversights in manufacturing can have massive consequences, and it set the stage for stricter controls and advanced testing methods to protect patient safety worldwide.

The fun fact is that nitrosamines aren’t just in pharma – they can also be found in smoked meats, beer, and even cosmetics. In medicines, however, standards are far stricter. Quinta has developed and operates advanced methods to detect nitrosamines and their analogues, ensuring drugs meet the highest safety standards. The challenge here, though, is about the concentration levels that are being tested. We are talking about extremes like 2–3 ppb (part per billion). Imagine you have one billion drops of water. If just one drop contains a certain substance (nitrosamines here), that’s 1 part per billion (ppb). It’s an extremely tiny amount – like finding one grain of sugar in an Olympic-sized swimming pool. And this is the real beauty of the services we provide.

JIŘÍ RAŠKA is a seasoned expert in the pharmaceutical industry, holding his Ph.D. in physical chemistry. Over the years, he has held key roles in drug quality control and pharmaceutical production management. Since 2013, he has focused on business development and commercial strategy for companies involved in active pharmaceutical ingredients, drug manufacturing, and contract research. He currently serves as Chief Commercial Officer and Managing Partner at Quinta-Analytica, a Prague-based top-class contract research laboratory, and oversees pharmaceutical business activities at Conscio Group, Quinta’s parent company.

Founded in 1997 in Prague, Quinta-Analytica has grown into a globally recognized partner for pharmaceutical companies. Being based in the heart of Europe gives Quinta’s clients a major advantage. Testing medicines here means meeting strict EU regulatory standards, opening doors to one of the world’s most trusted healthcare systems.