The Material Sciences team offers essential support to ensure the quality of Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs) throughout their development and manufacturing within the pharmaceutical research and development domain. We extend our support across the various development stages, from advanced lead optimization through to commercial production.

Our areas of expertise encompass the following domains:

• Version / form selection
• Form control
• Crystallization development
• Solid state chemistry and particle engineering
• Physical properties characterization
• Pre-formulation assessment

We provide comprehensive support spanning from API to the final DP, including intermediate materials. Our operations are situated at the Evotec sites in Verona, Toulouse and Abingdon.

• Utilizing cutting-edge solid-state analytical technologies:
  • X-Ray Powder Diffraction (XRPD, including non-ambient and 2D) and Small Angle X-Ray Scattering (SAXS)
  • Particle Size Distribution (PSD) by Laser Light Scattering (LLS) and Dynamic Light scattering (DLS) with z-potential measurement
  • Thermal analysis like ThermoGravimetric Analysis (TGA, TGA with Evolved Gas Analysis – EGA) and Differential Scanning Calorimetry (DSC and modulated DSC)
  • Spectroscopy (FT-IR, micro Raman)
  • Polarized Light Optical Microscopy (pOM)
  • Environmental Scanning Electron Microscopy with Energive Dispersive X-Ray Spectroscopy (ESEM-EDX)
  • Specific Surface Area (SSA)
  • Dynamic Vapor Sorption (DVS)
  • True Density (pycnometry), envelope density, tapped and bulk density
  • Powder rheology and wettability

• Method development and cGMP validation on both API and drug product according to ICH and ISO guidelines (from Phase I to Phase III).
• API Pre-Formulation – Developability assessment (solubility in various simulated biorelevant media, pH solubility profile, pKa and LogP/D determinations, Intrinsic Dissolution Rate (IDR), potential phototoxicity assessment, solid state stress stability and stability in solution)
• Investigational studies –identification and resolution of issues through Root Cause Analysis processes, e.g. batch-to-batch variability, performance determinations (dissolution, bioavailability, flow properties), content uniformity, identification of Foreign Particles in API, drug product or delivery devices
• Collaborating closely with external partners for specialized solid-state techniques like Solid State NMR (ssNMR), Single Crystal XRD (sc-XRD), Synchrotron Based XRPD (s-XRPD)

• Polymorph screening to mitigate risk of failure during development, adhere to regulatory standards and safeguard intellectual property
• Optimizing drug performance and enhancing physicochemical attributes through strategic salt and co-crystal selection
• Developing amorphous dispersions to increase solubility and bioavailability 
• API Forms thermodynamic-kinetic relationships, relative physico-chemical stability, key properties differentiators, phase diagrams
• Mastering crystallization development to control established critical quality attributes via the final API production route, encompassing version, crystal form, particle size, particle morphology, and chemical purity, through particle engineering strategies.

• State-of-the-art analytical techniques/ instrumentation in the physical properties characterization labs 
• Robotic solid form screening (paired with classical screening approaches) and modern multi-parallel reaction stations with PAT tools (e.g. FBRM, Raman) in the solid state chemistry area 
• Integrated proficiency and facilities spanning solid-state chemistry and physical properties, ensuring continuity from API to drug product under one team
• Offering analytical services and support to both API and drug product, for stand-alone and integrated projects
• Transfer knowledge from API to DP manufacturing influencing critical quality attributes and final formulation decisions
• High performance and flexibility (focused on client needs and adaptable to any change with a quick turnaround time) 
• Emphasizing data reliability, quality and integrity 
• Proven expertise in the pharmaceutical material science, solid state chemistry and developability – pre-formulation fields and well recognized reputation by the scientific community