Pharmaceutical analytical services

CLS-logo.png Concept Life Sciences provides an unrivaled 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 optimization 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.

Our capabilities

Our standard capabilities include:

  • 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
  • Specialized, high-end materials characterization
  • Elemental and Raw materials analysis
  • Key performance indicators
  • Pre-formulation, formulation, manufacturing support
  • Pharmacopoeial monograph testing
  • Storage stability

Some of our specialist capabilities are also listed below.

Materials characterization capabilities

  • X-Ray Diffraction
  • Particle analysis using the Malvern Panalytical Morpholgi 4-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 behavior 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 capabilities

  • 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 capabilities

  • Method development from first principles to full GMP / GLP validation and beyond
  • HPLC / uHPLC
  • UV, PDA, DAD, Fluorescence
  • 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