Innovative Partners With The Global Pharmaceutical Community

PROCESS R&D


Apotex Pharmachem Inc.'s Process R&D team is composed of organic chemists, chemical engineers and technicians educated in leading universities and colleges within Canada and abroad. These highly skilled and innovative staff specialize in all aspects of API process research and development. With over 200 APIs developed to date involving complex, multi-step syntheses, Apotex Pharmachem Inc.'s experienced Process R&D team is well positioned to continue on its innovative development path.


PROCESS R&D CAPABILITIES

R&D Our extensive experience in process R&D for active pharmaceutical ingredients encompasses:

  • Small Molecule and Synthetic Route Design
  • Custom Synthesis and Characterization
  • API Solid State Development (Polymorph)
  • Novel API Salt Forms
  • Specification Development
  • Process and Material Hazard Screening
  • Design of Experiments
  • Forced Degradation Studies and Stability Evaluation
  • Full Database Searching (CAS STN Express®, Scifinder, Beilstein)

Apotex Pharmachem India Pvt. Ltd. (APIPL), Bangalore, India and Apotex Pharmachem (Tianjin) Inc. (APTI), China, are affiliated R&D sites providing additional resource and expertise and a global R&D presence.

Selected Process R&D Instrumentation and Equipment Includes:

  • Automated Multireactor System
  • Solid-Phase Peptide Synthesizer
  • Reaction Calorimeter
  • Adiabatic Calorimeters
  • In-Situ FTIR
  • Powder Safety Testing Apparatus– MIE, Charge Decay, Impact/Explosive Testing
  • Preparative HPLC
  • NMR Spectrometers: Multinuclear and Gradient, VT, Autosampler
  • Differential Scanning Calorimeters (DSC)
  • Thermogravimetric Analyzer (TGA)
  • LC/MS/MS
  • GC/MS
  • Powder X-Ray Diffractometer

CHEMISTRY CAPABILITIES


As a result of our scientific team's expertise, we have proven experience with a variety of molecular targets and a wide range of synthesis methodologies.

Selected Molecular Targets:

  • Prostaglandins
  • Steroids
  • Peptides and Polypeptides
  • Polymers
  • Nucleosides
  • Carbohydrates
  • Heterocycles
  • Inclusion Compounds/Co-crystals

Selected Synthesis Methodologies:

  • Enantioselective and Stereoselective Synthesis
  • Classical Resolutions
  • Asymmetric Catalysis
  • Solid-Phase Synthesis
  • Supercritical Fluids
  • Phase Transfer Catalysis
  • Organometallics (Li, Mg, Pd, Ru, Sn, B, Si, Al, etc.)


FACILITIES, INSTRUMENTATION & EQUIPMENT


Apotex Pharmachem Inc.’s world-class 30,000ft2 Process R&D laboratory facilities are furnished with an array of state-of-the-art instrumentation and equipment.

Our state of the art facilities include:

  • Process R&D Laboratories
  • Custom Synthesis Laboratory
  • Process Scale-Up and Hazard Screening Laboratory
  • Characterization Laboratories
  • Kilo Laboratory

Selected Process R&D Instrumentation and Equipment Includes:

  • Automated Multireactor System
  • Solid-Phase Peptide Synthesizer
  • Reaction Calorimeter
  • Adiabatic Calorimeters
  • In-Situ FTIR
  • Powder Safety Testing Apparatus– MIE, Charge Decay, Impact/Explosive Testing
  • Preparative HPLC
  • NMR Spectrometers: Multinuclear and Gradient, VT, Autosampler
  • Differential Scanning Calorimeters (DSC)
  • Thermogravimetric Analyzer (TGA)
  • LC/MS/MS
  • GC/MS
  • Powder X-Ray Diffractometer

© 2010 Apotex Pharmachem Inc.