White Papers

Nanomedicines demand tight control over particle properties, reproducibility, and scalability, yet conventional batch methods often struggle to deliver all three. In this whitepaper, Ardena’s nanomedicines experts Mark van Eldijk and Andy Bänziger explore how flow manufacturing can enable more consistent nanoparticle production, simplify scale-up, and support robust development pathways from early-stage research through GMP manufacturing. […]

The ICH has released a draft consolidated guideline (ICH Q1) that unifies the previous Q1A–Q1F series into a single global standard. This revision simplifies stability requirements, integrates lifecycle management, and expands the scope to advanced therapies and drug-device combinations. This whitepaper provides a clear overview of the key changes — from predictive tools and modeling […]

Nanomedicines are redefining pharmaceutical innovation, but their complexity demands advanced analytical solutions.In this whitepaper, Ardena explores the analytical and regulatory challenges of characterizing nanoparticle-based drug delivery systems, and how state-of-the-art techniques like AF4-MALS-DLS can provide critical insights into particle size, morphology, stability, and drug loading. Gain a deeper understanding of: – How to identify and […]

Excipients are no longer passive ingredients—they’re critical to the success of precision drug delivery systems. In this whitepaper, Ardena shares insights into the development and GMP manufacturing of two novel phospholipids used in nanomedicine applications, including oncology and thermosensitive liposomes. Gain a deeper understanding of: – Control strategies for novel excipients – Overcoming analytical and […]

How can the pharmaceutical industry improve efficiency, sustainability, and adaptability in API manufacturing? In this whitepaper, Dirk-Jan van Zoelen, PhD, explores how applying the 6M framework—Manpower, Method, Machine, Material, Measurement, and Mother Nature—enables scientific and operational innovation across the development and scale-up of small molecule APIs. Learn how emerging technologies like AI, flow chemistry, enzymatic […]

Drug discovery and the scale-up of newly developed manufacturing processes represent an exciting and dynamic field for academic scientists, startups, and small to large pharmaceutical companies. The scale-up to clinical batch sizes, in particular, poses challenges as lab-scale manufacturing expands to batch sizes in the multi-kg range, requiring further optimization of manufacturing processes. Due to […]

In the ever-evolving landscape of pharmaceutical research, Ardena stands at the forefront with unparalleled expertise in solid state chemistry. Our whitepaper explores the pivotal role of solid state chemistry in drug development, emphasizing how meticulous polymorph screening and rational solid form selection can significantly accelerate the journey from discovery to market. By addressing the complexities […]

This whitepaper explores Ardena’s strategic methodology for addressing the challenges in synthesizing highly potent compounds (HPAPI) during early drug development. Emphasizing a rational risk-based approach, the paper outlines key factors in achieving safety, efficiency, and compliance with regulatory standards. The methodology includes continuous risk assessment, facility design based on Occupational Exposure Bands (OEB), and a […]

With increasing progress in the life sciences, we are constantly broadening our ability to treat diseases that were previously incurable. This progress however comes with new challenges due to the growing complexity of chemical and biotherapeutic products. Developing and manufacturing the compound of interest in a pure and stable form quickly and efficiently is considered […]

Drug development requires an average overall investment of USD 1.5 – 4.5 billion and remains at high risk due to the huge attrition rate phase after phase. The pre-clinical development phase and the phase 1 clinical trial show the highest attrition rate due to toxicity or drug metabolism and pharmacokinetic issues. Mitigating the risk during […]

The chemical synthesis and supply of a drug substance is a time critical step in the process of defining and selecting a lead drug candidate for progress into a toxicology program and subsequently into first-in-human clinical trials. The presence of impurities can hinder toxicology results and delay entry into the clinic therefore it is important […]

Antibody-Drug-Conjugates (ADC) have emerged as an efficient technology to deliver cytotoxic drugs into cancerogenic cells. The mechanism is based on an antigen-mediated uptake of a cytotoxic drug conjugated antigen via clathrin-mediated endocytosis and release of the drug after lysosomal cleavage to its intracellular target. With 14 ADCs currently approved worldwide, ADCs have proven their therapeutic […]