June 26, 2017
RSS

Service Scope and Quality

Currently, OKAPI Chemtech primarily provides preclinical and other non-GMP synthesis and development services. However, we will execute phase appropriate and sound process R&D work suitable for the production of clinical batches under cGMP conditions and generate detailed and comprehensive technology transfer packages as needed for GMP production at a third party organization. Additionally, we will avail ourselves to interface and overlap with the third party to ensure that the transition is accomplished as seamlessly as possible.

As a matter of practical interest, the impurity profile of materials destined for GLP toxicological evaluation (process impurities, residual solvents, degradants, etc.) is a primary consideration when developing a process for the production of the toxicological lot. Through the biological safety assessment in animal models, impurities are qualified at defined qualification levels in parallel with the safety evaluation of the API prior to Phase I (first-in-human) clinical trials. Any new impurities along the development path will require qualification via bridging tox studies, a prospect that adds to cost and can cause significant delays in the development program. For these reasons, we employ scientifically sound analytical methods to ensure good control of the quality of the materials that we synthesize.

OKAPI Chemtech is housed in modern research facilities and has on site access to state of the art instrumentation and testing capabilities from the Eastman Business Park Analytical Sciences Division. Capabilities of interest for the analysis and characterization of pharmaceuticals include the following:

Chemical separation:

  • GC, GC/MS
  • Ion chromatography – IC, IC/MS
  • HPLC, LC/MS, size exclusion chromatography

Chemical structure analysis and elucidation:

  • MS, LC/MS, LC/tof MS, MS/MS, HRMS for empirical formula determination, MALDI
  • NMR – for solution phase and solid state analysis; 300, 400 and 500 MHz; multinuclear; complete range of 1-D and 2-D techniques, including variable temperature, VT-NMR (-100 to +250 oC); solid state NMR capabilities include CP/MAS, 1H CRAMPS and deuterium NMR
  • X-Ray Diffraction – including in-situ, low/high temperature VT-XRPD (to assess polymorphic phase transitions or solid-state reactions), micro-diffraction, in-situ non ambient diffraction (under N2, He or controlled humidity); Single Crystal structure determination
  • IR spectroscopy
  • Raman spectroscopy
  • UV-Vis

Thermal analysis:

  • DSC: -150 to 500 oC; modulated DSC: -70 oC to 400 oC
  • TGA, TG-IR

Micro-characterization of materials:

  • Scanning electron microscopy – SEM
  • Transmission electron microscopy – TEM
  • IR
  • Raman (laser excitation at 488 nm, 514 nm, 633 nm, or 785 nm and CCD array detection) or laser excitation at 1064 nm and FT-Raman detection
  • Optical microscopy (magnification from 1X to 2500X; reflected light, polarized light, fluorescence, etc.)

Particle Sizing:

A variety of techniques and instrumentation

Trace Elements and Ion Characterization:

  • Atomic Absorption Spectroscopy (AAS)
  • Inductively Coupled Plasma – Atomic Emission Spectroscopy (ICP-AES)
  • Inductively Coupled Plasma – Mass Spectrometry (ICP-MS)

At the inception of each project, we review with our customer the overall project goals and clearly define the deliverables and identify key milestones. Open, clear and regular communication between all parties is maintained at all times, and any issues arising during the project implementation are immediately and transparently discussed to decide on the best corrective action. Outcomes for each project are communicated in detailed reports.