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
In this webinar you will learn what it takes to bring a candidate from the laboratory to first-in-human clinical trials, with a focus on a phase-appropriate strategy for drug substance process and analytical development, scale-up and manufacturing.
We will discuss key aspects that must be addressed to successfully transform a medicinal chemistry route into a manufacturing process capable of delivering a drug substance of necessary quality for clinical trials:
Alternative chemical route scouting and route comparison.
Challenges in scaling up of a new synthesis route for the target drug substance.
Development of analytical package: analytical methods, in-process controls, quality specifications.
Investigation of the impurity profile in drug substance, highlighting the importance of detecting and quantifying impurities and tracking these back to their point of origin.
Importance of solid-state research for drug substance: salt and polymorph screens, development of crystallization step and more.
General aspects of project development to address the need for fast delivery of drug substance often associated with projects in early clinical development phase.
Presenters
Juris Fotins, PhD
Principal Scientist
Drug Substance Process Development
With a PhD in organic chemistry and more than 15 years of experience, his professional career in medicinal chemistry started at an academic institution In Latvia. Later moved to process chemistry at local pharmaceutical company. Joined Ardena as principal scientist focusing primarily on development of manufacturing processes for various drug substances. Currently, next to managing chemistry projects, is also involved in technical sales for Ardena Sodertalje.
Petter Tollbäck, PhD
Principal Scientist
Drug Substance Analytical Development
More than 15 years of experience of pharmaceutical development.
Developed hundreds of methods for a large variety drug substances and products – pre-clinical to commercial.
Our team members share deep, scientific understanding and insights into their respective fields of expertise.
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