Material sciences

 

The Material Sciences team provide support to guarantee the quality of API/ drug products developed and manufactured in the pharmaceutical development area, to support the development phases from advanced lead optimisation to commercial. Our areas of expertise are: version selection, form control, crystallisation development, particle engineering and solid state landscape determination. Our support encompasses API, DP, and intermediate material. Our locations are at the Verona and Toulouse Evotec sites.

Materials Characterisation

  • State-of-the-art solid state analytical technologies and expertise including spectroscopy (FTIR, Raman, NMR), diffraction (XRPD, also non ambient and 2D), SAXS, thermal analysis (DSC, TGA, TGA-IR), microscopy (PLM, ESEM+EDX), micromeritics (particle size, surface area, DVS, pycnometry, powder rheology, wettability)
  • Method development and cGMP validation such as qualitative or quantitative methods on both API and drug product
  • Investigational studies – assessment of materials (to help determine origin and resolution of issues), e.g. batch-to-batch variability, performance determinations (dissolution, bioavailability, flow properties), content uniformity, presence of unknown materials focusing on API, DP, or delivery devices
  • Strong and close cooperation with external partners for particular solid-state techniques like ssNMR, single crystal XRD, synchrotron radiation based x-rays diffraction

API Version/ Form Selection and Control

  • Polymorph screening to reduce the risk of failure during development, to meet regulatory requirements and to preserve IP
  • Salt/Co-crystal selection to improve drug performances and enhance physicochemical properties
  • Amorphous dispersions development to increase solubility and bioavailability
  • Forms thermodynamic-kinetic relationships, relative physico-chemical stability, key properties differentiators, phase diagrams
  • Crystallisation development to control established critical quality attributes via the final API production route (e.g. version, crystal form, particle size, particle morphology, chemical purity) with a particle engineering approach

Areas of Excellence

  • State-of-the-art analytical techniques/ instrumentation in the physical properties characterisation labs
  • Robotic solid form screening and modern multi-parallel reaction stations with PAT tools (e.g. FBRM, Raman) in the solid state chemistry area
  • Integrated expertise and facilities for both solid state chemistry and physical properties: same team is following the project from API to DP
  • Possibility to serve as analytical service as well as support group to API and DP (stand alone and integrated projects)
  • Transfer knowledge from API to DP manufacturing influencing the critical quality attribute and the choice of the final formulation
  • High performance and flexibility (adaptable to any turnaround time for data production)
  • Focus on data reliability, quality and integrity
  • Proven expertise in the pharmaceutical material sciences – solid state chemistry fields and well recognised reputation by the scientific community

Contact us

Evotec

Business Development

T +44.(0)1235.86 15 61 F +44.(0)1235.86 31 39 vCard
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