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Expert Interview : 6 questions to our Analytical Development expert

23/01/2025
Article

We asked 6 questions to our Analytical development expert Pirjo Luoma-Tokoi, PhD. Pirjo is R&D Analytical Development Manager at Seqens’Lab, and she shares her insights on this pivotal expertise for drug development.

In the pharmaceutical field, how important is the analytical science expertise?

As we develop new molecules for our clients, we have to define the methods that quality control will use to verify the conformity of the active ingredient, raw materials and synthetic ingredients manufactured before using them.

Before launching the commercialization of any new active ingredient, we need to provide part of the established data to the regulatory department, which compiles and submits them to the authorities that will issue the sale authorization for the drug.

In order to reach compliance, excellence in analytical science is essential for method development and validation, along with chemistry manufacturing and controls (CMC).

Can you explain how to measure and control impurities in drug substances?

The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances.

Therefore, the first step in analytical method development is to proactively determine all potential impurities and assess the risks with the chemical development department.

Analytical Method Development involves a systematic approach to evaluating and selecting suitable methods that are sensitive, specific, and robust, and can be used to measure the target attribute within acceptable limits of accuracy and precision.

What are the current challenges regarding impurities control?

Since the “nitrosamine crisis” in 2018, all international communities have changed fundamentally their view on how to deal with impurities. The need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds is of paramount importance.

At Seqens, we can identify and quantify Nitroso Drug Substances Related Impurities at ppb (parts per billion) level in Active Pharmaceutical Ingredients.

Learn more about Nitrosamines with our Webinar about how to deal with the new guidance during Drug Product development?

How do you ensure that analytical methods are robust and compliant with legal authorities requirements?

At Seqens, we follow regulatory (FDA, EMA, etc.) guidance, as well as instructions from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for any analytical method development and validation.

The goal of analytical method development and validation is to ensure that the methods used to measure the identity, purity, potency, and stability of drugs are accurate, precise, and reliable. Analytical methods are critical tools for ensuring the quality, safety, and efficacy of pharmaceutical products in the drug development process.

Method Validation is the process of demonstrating that an analytical method is suitable for its intended use, and that it is capable of producing reliable and consistent results over time.

At Seqens, we implement Quality-by-Design methodology in our analytical methods (AQbD). As a result, it enhances method robustness, reducing errors and out-of-specification results during routine use, leading to fewer post-approval changes and increased cost-effectiveness.

It emphasizes systematic method development, risk assessment, and evaluation of method parameters to ensure optimal performance and robustness. This approach supports successful method validation and transfer, offering regulatory flexibility by allowing changes within the method’s robustness area without requiring revalidation.

How would you describe your department’s specificity compared to other CDMOs?

Within our cutting-edge equipment and our excellence in analytical science but also in organic chemistry, we work side by side with the chemical development department to set the specifications (such as purity, dosage, degree of residual solvents allowed, etc.) of the active ingredient developed.

At SEQENS, we provide a full package to support our Clients from Risk Assessment to nitrosamines screening and control of routine production, within cGMP compliance.

Further to the identification, the toxicological characterization of the Nitroso Drug Substances Related Impurities should be performed. At SEQENS, we provide support services for Mutagenic and Genotoxic studies.

My department is at the cornerstone of several departments such as chemical development, regulatory affairs, the project management team, quality control and the marketing department which is the link with the customer for whom we are developing the molecule.

Can you tell us more about the cutting-edge equipment you have in the analytical department?

Depending on the attribute being assayed, we use state-of-the-art instrumentation such as HPLC (with UV-Vis/DAD, RI, CAD, etc. detectors), UHPLC-HR-MS/MS, GC-FID-MS/MS, NMR etc.

We have the expertise and cutting-edge analytical instruments to tackle challenging impurities.

What about analytics expertise for characterizing excipients and controlling  their quality, such as bioresorbable polymers?

SEQENS has unique know-how and experience in the development and production of Specialty excipients, such as its existing range of bioresorbable polymers Expansorb® (PLA/PLGA/PCL catalog). We also work on hydrosoluble polymers like PEI, PBAE, PEG, PLL, polyoxazolines, polyacrylates, modified polysaccharides, derivatives and co-polymers thereof.

Gel Permeation Chromatography (GPC) is essential for measuring molar mass and their distribution. GPC technique is related to a column liquid chromatography system that relies on separating the components of a mixture on specific materials according to molecule size.

In our excellence center in Aramon, in South of France, we are equipped with GMP qualified triple-detection size-exclusion chromatography systems. As a result, we measure average molar mass: in numbers, in weight and dispersity index.

We are also equipped with a GMP qualified 500 MHz NMR equipment leading to increased resolution with high accuracy and reproducibility, leading to structure characterization of products and their impurities and also their quantification.

What is your background?

After graduating from high school in Finland, I followed a master’s degree in organic chemistry in University of Oulu. During my studies, I had the chance to study in Ireland thanks to the Erasmus program. I then did a thesis in analytical chemistry in Finnish Institute of Occupational Health.

As Head of the analytical methods department, we focus on projects for the development of pharmaceutical active ingredients.

At SEQENS, through our SeqensAnalytics technology platform, we provide a broad set of expertise including full characterization of substances and standalone analytical services offering including nitrosamines.

📧 Contact us at info.cdmo@seqens.com to discover how we can support your new asset development !