Process development, analytical development, analysis, stability testing, manufacturing
Crystal structure by X-ray, solid form screening, solid form selection, IP support
Formulation development, analytical development, manufacturing, stability studies
Packaging, labeling, clinical trial logistics
Mass spectrometry, immunochemistry, flow cytometry, in-vitro drug discovery, clinical trial services
Scientific report writing, module 3 writing, regulatory CMC support
Guiding your nanomedicine candidate through its journey to the clinic
Developing and manufacturing formulations that lead to improved bioavailability
Meeting your needs from pre-clinical to small-scale commercial manufacturing
Bringing your oral drug to clinical trials quickly and reliably
Guiding you through the development of injectable drug products to GMP standards
Enhancing biomolecule purity with tailored solutions for GMP-grade materials at scale
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.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
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.
Always agile, we reliably guide you and your molecule through the challenging terrain of early phase development
Carefully engineered to support and enable early phase development for our partners’ oral drugs, injectables and nanomedicines
Our leadership team has a deep scientific understanding combined with exceptional experience
Platforms and facilities that are uniquely engineered to support and enable integrated early phase development
We’re a fast-growing EU-based company with many opportunities for you to grow and progress with us
Polymorphism in pharmaceuticals may affect drug product (DP) development, clinical studies, manufacturing, quality and stability. Therefore, it is mandatory to gain knowledge of the polymorphic behaviour of active pharmaceutical ingredients (APIs) in the early development phase by performing polymorph screen programs.
The Importance of Polymorphism
in Drug Development, crystalline APIs often exhibit the “polymorphism” phenomenon, meaning that different crystalline arrangements of an API are possible in the solid state. The API’s polymorphic behaviour can significantly affect its physical properties.
Polymorphic transformations can be prompted in DP manufacturing by physical processes, including compression, grinding, milling, processes involving solvents and moisture, or under storage conditions. Unexpected changes in polymorphic form may affect the quality and efficacy of the final DP and dramatically impact patients.
The most notorious example of polymorphic conversion affecting DP quality and efficacy is the Ritonavir case Form I, the only solid form of Ritonavir known in 1996, was marketed as a liquid formulation in hydroalcoholic mixtures. In 1998, precipitation from the DP solutions was noticed. This precipitation affected the API bioavailability as a lower amount of drug was present in the solution. Due to this inconsistency in the DP, Abbott had to remove the oral capsule formulation from the market. Investigations revealed that the emerged solid was a more stable polymorph, hence less soluble, known now as Form II. Eventually, the issue was solved, and the product returned to the market as a gel cap formulation. The discovery and reformulation of Ritonavir cost $250 million.
This whitepaper covers the issues related to polymorphism in drug development the benefits of experimental polymorph screen studies.
Please fill out the form to unlock the rest of the content.
Our team members share deep, scientific understanding and insights into their respective fields of expertise.
Sign up to receive drug development insights, the latest on industry trends & Ardena news.