Crystallization and Solid-State Services
In Phase 3, more than 50% of compounds that fail do so due to poor efficacy, which means that the selection of the right solid form, and the associated understanding of the physical properties of the API, will increase the chances of clinical success, thus reducing the overall cost of development.
Through a preferred partnership arrangement with solitek, Charnwood Molecular is pleased to offer a range of services to allow our clients to explore the solid form characteristics of their compounds.
Solid State Characterization
• Understanding physical properties
• Investigating batch-to-batch variability
• Helping the selection of the drug candidate
Solid Form Screening and Selection
• Polymorphs, salts and cocrystals
• Medium throughput approach
• Fully inclusive
Crystallisation Process Development
• Stage appropriate development
• Early investigation of crystallization processes to reduce later costs of development
• QbD approach using solubility and supersaturation modelling and statistics
• Assessment of mixing effects on scale-up
Early Enabling Preclinical Formulation Development
• Bridging the gap between discovery and development
• Inexpensive solutions to take you over the next hurdle
• In-vitro models for in-vivo success
Our partners at solitek have in-depth knowledge of the thermodynamic and kinetic factors that are fundamental to crystallization, and have experienced the potential problems that can occur at all of the development stages and during production in the plant.
In collaboration with solitek we can now offer an invaluable advantage in solving problems relating to control of solid form and particle size distribution, and therefore the underlying issues of stability and solubilization – issues that should be considered early in the development pipelines are led by solid form experts Dr. Victor Diaz and Dr. Steve Winter, who bring significant industrial experience of these challenges.
Dr Victor Diaz holds a PhD from the University of Seville in organic chemistry, synthetic and medicinal chemist. Victor has led some of the larger solid-state teams in Europe providing services to pharmaceutical and biotech companies for over 15 years, including with companies such as Almac Sciences and Pharmorphix.
Dr Steve Winter holds a PhD from the University of Cambridge, starting his career in the area of asymmetric organic synthesis before moving into the field of solid form. He has experience at all stages of product development, from drug discovery to manufacturing and is an expert in crystallization process development, polymorphism and particle size control, having worked for several companies including Esteve, Medichem and Pharmorphix.
Charnwood Molecular offers a range of additional services, including Process Research & Development, Medicinal Services and Grant Funding Partnerships. Find out more about our services.
Process Research & Development
Our Process Research Team has over 100 years of combined experience.Process Research and Development
Our talented synthetic chemists have been delivering challenging molecular research for deCustom Synthesis
Grant Funding Partnerships
We have always had a unique understanding of the nature of grant-funded partnerships.Grant Funding Partnerships
Contract Research including Route Development and Route Optimisation
For your contract research needs, get in touch with Charnwood Molecular today.Contact