Early development

Regulatory agencies have requirements your product must comply with. Early testing makes your decisions more informed and saves time. To have the information when you need it (or even before), choose one (or a combination) of our early development services:

Preclinical candidate and API characterization

You can rely on us to perform preclinical candidate characterization including the assessment of chemical and physical properties like crystallinity, thermal properties, solubility and stability. These properties can be a limiting factor in the efficacy of the API and can cause unwanted costs. Therefore, we offer screening and characterization of polymorphs, salts and co-crystals, ideally to be performed while a drug candidate is still in the discovery phase.

  • Solubility studies
  • Solubility in organic solvents
  • Solubility in bio-relevant media (SGF, FaSSIF, FeSSIF)
  • Solubility in buffers
  • Solubility in aqueous media with solubility enhancers
  • Stability studies
  • Solution stability
  • Solid state stability
  • Storage conditions according to customer requirements:
  • Open and/or closed vial
  • Various temperatures
  • Various humidity
  • Light stability (ICH conditions)
  • Solid state characterization
  • X-ray powder diffraction (XRPD) – ambient temperature and relative humidity, variable temperature and variable relative humidity
  • Single crystal X-ray diffraction
  • Thermogravimetric analysis (TGA)
  • Differential scanning calorimetry (DSC)
  • Fourier transform infrared spectroscopy (FT-IR)
  • Hot stage and optical microscopy
  • Form and version screening
  • Polymorphs
  • Salts
  • Co-crystals

Non-GLP analytical development

You have an analytical method. Or you don’t. Either way, we can help by developing methods tailored to your compound or optimise an existing one. In addition, we can support chemical manufacturing and control activities (CMC) by providing comprehensive analysis of process related substances with impurity profile comparisons. Our offering includes:

  • UPLC / HPLC method development
  • UPLC / HPLC method transfer

Analytical testing

  • Reference substance characterization with Certificate of Analysis or full scientific report
  • Separation, structural analysis and synthesis of impurities and degradation products
  • Isolation of low level impurities
  • Fragmentation studies by MSn and accurate mass measurements
  • Forced degradation
  • Enantiomeric purity assessment
  • In-process control

Rules and regulations

  • International Conference on Harmonisation (ICH) guidelines and other globally recognized standards
  • Strict environment, health and safety regulations
  • High data integrity standards to help with your intellectual property protection
  • Scientific reports, Certificate of Analysis and laboratory notebooks are written in English
  • Forced Degradation Study
  • Isolation, Structure Analysis and Synthesis of Impurities, Degradation Products and Metabolites
  • Isolation of Low Level Impurity
  • Solid and Solution Stability and Solubility
  • Crystal Structure and Physicochemical Properties
  • Understanding Solid State Behaviour – Hot Stage Microscopy
  • Fragmentation studies by MSn and accurate mass measurements

Early development analytical instrumentation

  • XRPD: PANalytical X’Pert Pro powder diffractometer model PW3050/60
  • DSC: Mettler Toledo DSC 822e
  • TGA: Mettler Toledo TGA/SDTA 851e
  • HSM: Linkam THMS 600 hot stage/ Olympus BX51 microscope
  • OM: Olympus SZX12 stereomicroscope
  • IR: Excalibur FTS3500GX equipped with DuraSampleIR II
  • Mill: Retsch MM301
  • Stability chambers:
  • Binder FED720
  • Binder KBF720
  • Vötsch VCL4301
  • ATLAS SunTest CPS+
  • UV-Visible spectrophotometer: Varian Cary300 Bio
  • Access to Oxford Diffraction Xcalibur CCD diffractometer