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Process development, analytical development, analysis, stability testing, manufacturing
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Guiding you through the development of injectable drug products to GMP standards
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Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Helping you turn your compounds that show promise into GMP-grade drug substances.
We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.
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Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.
We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.
Agile and reliable, we guide you and your molecule through the complexities of drug development.
A legacy of scientific excellence, development expertise and integrated solutions.
Seven GMP/GLP facilities across Europe and the US, supporting innovation.
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A dynamic, passionate, and growing team with opportunities to learn and make an impact.
In this Ardena Insight, we explore the critical role of solid-state screening in identifying stable polymorphs during drug substance (DS) development. Polymorphs, crystalline forms with the same chemical structure but different molecular arrangements—can dramatically impact solubility, dissolution, flow properties and overall processability.
Inadequate understanding of DS solid-state behavior can lead to unintended polymorphic conversions during processing or storage, affecting manufacturability, bioavailability and clinical outcomes. Switching between polymorphs during clinical development may also trigger the need for costly bridging studies to satisfy regulatory requirements.
At Ardena, we help you strike the right balance, providing expert guidance on when and how to invest in solid-state screening. Our tailored approach ensures that you mitigate risk without incurring unnecessary cost, aligning your development strategy with both scientific and regulatory expectations.
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