Nitrosamines have become a priority concern for regulatory authorities worldwide due to their potential carcinogenic risk, even at trace levels. Under ICH M7, pharmaceutical developers are expected to conduct thorough risk assessments, implement effective controls, and document their approach to managing these impurities. For many organizations, navigating these requirements can be complex and highly technical.
In this expert Q&A, Ardena’s CMC specialists Karel Aelvoet, Ph.D., Joost Steverlynck, Ph.D., and Bram Ach, Ph.D., share practical insights on how to evaluate nitrosamine risks, apply analytical methods, and use frameworks like CPCA to set acceptable intake limits.
Open the document to learn how regulators view nitrosamines, what strategies are recommended, and how to prepare your development programs for compliance
Microfluidization for Precision Nanoparticle Engineering
Microfluidization plays a crucial role in the development of liposomes, lipid nanoparticles (LNPs), nanoemulsions, and polymer-based drug delivery systems. This high-shear processing technology enables precise control over particle size, uniformity, and stability—key factors in optimizing therapeutic performance.
In this expert Q&A, Ardena’s nanomedicine specialists delve into how microfluidization compares to other nanoparticle production methods, its scalability for pharmaceutical manufacturing, and its ability to encapsulate sensitive biologics.
Insights into Thermogravimetric and Evolved Gas Analysis
Thermogravimetric analysis (TGA) and evolved gas analysis are key techniques for understanding the thermal behavior of APIs. In this Q&A with Ardena Experts series, Mieke Nap, Senior Scientist and Group Lead for Solid State Research, provides valuable insights into how Ardena’s advanced TGA-MS system analyzes mass loss and volatile components during thermal events.
Design of Experiments (DoE) and its relevance in API crystallization process development
Dive into the intricacies of pharmaceutical solid-state research with Laura Spix, a seasoned Senior Scientist and Group Leader in Solid State Research at Ardena. Gain valuable insights into the challenges of API crystallization, the pivotal role of Design of Experiments (DoE), and the advanced equipment employed by Ardena.
Dynamic Vapor Sorption (DVS) and its relevance in API characterization
DVS involves exposing solid samples to varying humidity conditions while closely monitoring weight changes, offering valuable insights into water-material interactions. María Jesús Martín, Project Leader in Solid State Research. highlights DVS’s crucial role in stability studies, investigating polymorphism and hydrate formation, quality control, and optimizing drying processes in pharmaceutical development.
This document also explores the equipment used for DVS, its application in studying different solid forms, and a classification system for hygroscopicity. Discover the ins and outs of DVS, including its limitations, illustrated with practical examples of sorption/desorption profiles.
The importance of API Intrinsic Dissolution Rate and how to determine it
Understanding the intrinsic dissolution rate (IDR) of active pharmaceutical ingredients (APIs) is a fundamental aspect of pharmaceutical development. At Ardena, we recognize the pivotal role of solubility determination, especially when dealing with low solubility in aqueous media. This introduction sets the stage for exploring the differences between thermodynamic and kinetic solubility, our advanced IDR measurement equipment, and the profound implications of IDR insights in selecting the optimal solid form for further development. In this document, we delve into the intricacies of IDR, showcasing Ardena’s expertise in this critical pharmaceutical science area.
Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena
In the landscape of drug development, the handling of highly potent APIs (HPAPIs) has increasing significance. These compounds, characterized by their substantial pharmacological activity at exceptionally low doses, redefine the traditional paradigms of therapeutic intervention. By facilitating higher precision in dosing and attenuating undesired side effects, HPAPIs hold the potential to elevate drug efficacy to unprecedented levels. This Q&A with our expert Rob Abbenhuis, CHEM Division Manager at Ardena, explains the importance of effective HPAPI management in drug development, intertwining scientific advancement with the imperative of ensuring the well-being of personnel involved in these operations. The document provides a detailed exploration of Ardena’s meticulous approach to HPAPI handling, showcasing our commitment to both scientific rigor and safety.
Nearly 90 % of new chemical entities (NCEs) in development have inadequate aqueous solubility and bioavailability properties, critical for their efficacy and commercialization. Over the past two decades, there has therefore been a substantial rise in the adoption of amorphous solid dispersion (ASD) and amorphous APIs as enabling technologies by pharmaceutical companies seeking to tackle these inadequacies (see Figure 1). To shed some light on why, when, and how to exploit the amorphous state of active pharmaceutical ingredients (APIs), we ask our formulation experts Oluwatomide Adeoye, Formulation Scientist, and Timothy Pas, Group Leader – Formulation Development and Production at Ardena, for their qualified opinion on the advantages, challenges, and strategies for utilizing ASD technology in early drug development through regulatory approval and commercialization.
Comparison of ELLA and Meso Scale Discovery V-Plex technologies for biomarker analysis
Biotechne’s ELLA and Meso Scale Discovery’s V-Plex are two main technologies for biomarker analysis.
Our expert from Ardena’s Bioanalysis laboratory Sijranke Post, PhD, Scientist-Project Manager, provides a detailed comparison between these two technologies in this Q&A with Ardena Experts.
Nanoparticle manufacturing has typically relied on batch technology, but as batch sizes increase, scale-up issues become a concern. Flow technology offers a solution to these issues, operating a manufacturing process under constant process parameters to produce nanoparticle products of consistent quality, irrespective of batch size.
But while flow technology offers advantages in scale-up issues and process safety, it is not always the better choice for every process. Every nanoparticle production process is unique, and the decision to use batch or flow technology needs to be evaluated on a case-by-case basis.
Our experts Silvie Meeuwissen, Director Process R&D and Manufacturing Nanomedicines, and Wouter Veldmate, MSc. Senior Scientist – Process Development Nanomedicines provide key insights about flow technology in this Q&A with Ardena Experts.
