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J-STAR’s High Potency Capabilities Meet and Exceed Every Requirement

Recent trends in drug development have seen a surge in demand for high potency production capabilities, a demand J-STAR is perfectly positioned to meet.

Our state-of-the-art facility can help meet the needs of your high potency development programs as our subject matter experts ensure that we will handle your API programs with the highest level of care and safety to ensure success.

Process R&D and GMP High Potency Capabilities

For high potency projects we have:

  • A purpose-built Research & Development Lab, equipped with W2 isolators and 4 hoods with an OEL < 0.05 µg/m³.
  • Bench-scale lyophilizer unit, EZ Max 102 and 402 systems.
  • Glass-jacketed vessels (50, 100 mL) with Huber heating and cooling.
  • For ADC work, spin filters with MW cut-off and TSK gel filtration columns.
  • Analytical the lab has 2 Agilent HPLCs and 2 Agilent UPLCs.
  • Benchtop XRP Bruker, TA/Waters Discovery DSC, TGA, and microscope. SOPs are available for analysis by NMR and HRMS.

We offer a full Process R&D and GMP service that includes but is not limited to:

  • Evaluation of Existing Synthesis and Identify Steps or Sequences in the Route that May Pose a Problem for Large Scale Synthesis.
  • NOR/PAR/DoE and Fate & Purge Studies Reference Standard Synthesis Authentic Impurity Synthesis.
  • Purpose built High Potent GMP suites with scale up to 100 L jacketed Chemglass vessels, appropriate scale purification and lyophilizer apparatus.

State of the Art GMP High Potency Laboratory in Cranbury, NJ

  • The GMP HPAPI Kilo-lab has three processing suites, dedicated material storage room and equipment storage room for high potency GMP manufacturing projects. 
  • Two Quality Control labs for in-process, material release testing and stability testing
  • Separate locked area in the warehouse for GMP stability chambers