IND/IMPD Enabling Analytical Technologies

The diverse chemistry performed within SynConnection requires very broad and flexible analytical support. To meet this demand, SynConnection has invested in both state-of-the-art equipment and dedicated skilled people. This has resulted in a highly organized analytical department that performs hundreds of analytical runs daily using a variety of techniques, including NMR, LCMS, LCTOF, GCMS (headspace), IR, UV/VIS and DSC.

Analytical Development and Validation

Besides GMP manufacturing, SynConnection has a fully qualified analytical department available for the development and validation of analytical methods. The methods are implemented as in-process-controls or used for the release of intermediates or drug substances. The analytical data are provided in eCTD format for easy incorporation in your IMPD/IND drug substance section. Analytical methods used for drug substance and drug product release testing will be validated following the guidelines described in the ICH Q2(R1). The available analytical tools include:

  • For ID and purity: UPLC, HPLC, LC-MS, GC-headspace GC-MS, GPC, IR, UV, KF, TOC, Akta Pilot
  • For physical properties: DSC, SEM, microscope, Particle Sizer
  • For testing Drug Products: disintegration testing, dissolution testing
  • In vitro release testing (ARCS)
  • NMR, XRD, ICP-AES, LC-MS-ESI-TOF
  • Viable counts, endotoxins, sterility, GPC-MALS
  • ICH stability testing, forced degradation studies
  • Salt selection and polymorphism

Nanoparticle Analysis and Characterization

SynConnection has a full range of GMP qualified nanoparticle characterization tools in house. Besides analysis and characterization during the development of your nanomedicine, SynConnection has a manufacturing license in place that allows for the analytical release of bulk drug products. Specialized analytical capabilities for nanoparticle characterization include:

  • LC-CAD for assay of liposome constituents (free and bound)
  • DLS and SEC for particle size (zeta potential measurement and (cryo)TEM)
  • ARCS (Equipment for semi-automatic testing of In-Vitro Release)
  • mDSC for phase transition in the lipid layers
  • GelElectrophoresis to study surface charge (modification).
  • LC-MS, GC-MS, IR, NMR for identification of lipid degradation and modification.
  • pH, osmolality
  • Climate chambers from

Chiral Analysis Technologies

Resolving enantiomers can be painstaking, but with our experience, the extensive assortment of chiral columns, and automated method development setup, our rate of success is over 99%. Dedicated LC systems and GC systems are available for the separation of optical isomers by chiral chromatography.

NMR

The SynConnection NMR laboratory in Groningen has two fully equipped 300 MHz Varian NMR-units. A comprehensive solution-state NMR service ranging from fast and efficient high-resolution proton-, fluorine-, phosphorous- and carbon-NMR to complete structure elucidation of organic molecules can be offered. Routine NMR analysis service is offered for fixed rates per sample including standard solvents and sample preparation. Spectra are delivered in PDF-format via email to ensure rapid and convenient delivery. Raw data can be provided as well. We also offer NMR services for smaller sample amounts (from 100 micrograms), at variable temperatures (-60 to 100°C), for quantitative analysis and most 2D techniques (COSY, TOCSY, HSQC, HMBC, NOE, etc.) as well as data interpretation on request.