Analytical

Concept Life Sciences provides an unrivalled breadth of analytical solutions, techniques and applications to the pharmaceutical, medical device and advanced wound management healthcare sectors.

Concept is a specialist CRO focused on problem solving and delivering high quality analytical and laboratory support.

Our unique blend of spectroscopic, chromatographic, solid state and elemental analysis, combined with a wide range of compendial test methods, provide comprehensive analytical solutions from early lead optimisation and drug candidate selection through to GMP commercial release of raw materials, APIs and finished products.

We provide services to both the human and veterinary pharmaceutical sectors, amongst others.

Capabilities:

  • GMP and GLP accredited; FDA inspected
  • Method development, verification, validation and transfer
  • Quantitative methods / Limit tests
  • R&D, QC release testing, Analytical problem solving
  • Wide range of analytical techniques encompassing:
  • Separation sciences
  • Specialised, high-end materials characterisation
  • Elemental and Raw materials analysis
  • Key performance indicators
  • Pre-formulation, formulation, manufacturing support
  • Pharmacopoeial monograph testing
  • Storage stability
  • Materials characterisation

    • X-Ray Diffraction
    • Particle analysis using the Malvern Panalytical Morpholgi4-ID:
    • Static imaging
    • Automated shape analysis
    • Component specific Morphologically Directed Raman Spectroscopy (MDRS).
    • Particle size determination:
    • Malvern Mastersizer 2000 & 3000 Laser Diffraction, with Hydro MV, SM, S, Sirocco and AERO Dosing Units
    • Malvern Zetasizer Ultra and Nano S Dynamic Light Scattering
    • Sympatec HELOS / RODOS with VIBRI, ASPIROS and CUVETTE Dosing Units
    • Sieving / Sieve Shaker
    • Specific Surface Area analysis – BET and Porosity
    • Thermogravimetric Analysis / Differential Scanning Calorimetry / Modulated DSC / Hyper DSC
    • Isothermal Calorimetry
    • Dynamic Vapour Sorption
    • Optical microscopy / Scanning Electron Microscopy
    • Rheology:
    • Viscosity profiling (pseudoplasticity / dilatancy)
    • Yield stress determination
    • Viscoelastic behaviour determination (G’, G’’, phase angle)
    • Thixotropy assessments
    • Monitoring of curing processes
    • Axial testing
    • Dynamic Mechanical Analysis (DMA) of solid samples
    • Proton and Carbon NMR, plus other nuclei on request
  • Elemental and raw materials analysis

    • Inductively Plasma – Optical Emission Spectroscopy / Mass Spectrometry
    • Scanning Electron Microscopy – Energy Dispersive X-Ray analysis
    • Fourier Transform Infra-Red spectroscopy
    • UV-Vis Spectrophotometry
    • Viscosity, Density
    • Loss on Ignition / Loss on Drying / Residue on Evaporation
    • Sulphated ash / USP <231> Heavy metals
    • Total Organic Carbon
    • Melting point / pH / Conductivity
    • Manual and Autotitration, Karl Fischer analysis
    • Coulometric
    • Volumetric
    • Oven
  • Separation science

    • Method development from first principles to full GMP / GLP validation and beyond
    • HPLC / uHPLC
    • UV, PDA, DAD, Fluorescence
    • ELS, RI, CAD, MS, MS/MS
    • Gel Permeation Chromatography / Size Exclusion Chromatography with the Malvern Panalytical OmniSEC
    • UV-directed and Mass-directed Semi and preparative HPLC (for peak isolation / identification of unknowns)
    • Gas Chromatography
    • Liquid, Headspace, Solid-phase microextraction
    • FID, MS, MS/MS
    • Ion Chromatography (anions, cations, sugars)
    • Chiral separations
    • Thin layer chromatography
    • Dissolution

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GMP stability

Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release. Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

API release

Concept Life Sciences' specialist release test laboratory offers a unique blend of high-end materials characterisation techniques (e.g. XRPD, PSD) combined with standard chromatographic (including LC, GC, TLC, IC) and elemental / compendial techniques (such as ICP, LoD, Karl Fischer) to meet niche requirements.

Pre-clinical formulation

Concept Life Sciences offers a comprehensive service for pre-formulation and formulation development plus GMP sample production for pre-clinical trial materials. We test and release formulations according to development specifications and produce samples under GMP conditions ready for transfer to study teams.