December 15, 2019
  • Development and preclinical supply services.
  • Flexibility on the manufacturing of small batch size pilot lots for preclinical trials for efficacy, safety as well as other complementary studies for technology scale up.
  • Extensive experience working with complex substances such as biologics, including monoclonal antibodies, peptides and other proteins.
  • Expertise in lyophilization; appropriate manufacturing processes for both regulatory and efficiency purposes.
  • Flexible manual filling area available, for product-specific manufacturing processes for testing (smooth transfer later to commercial manufacturing).
  • Development of lyophilization cycles and conduct transfer and initial upscaling trials.
  • Feasibility studies, cycle optimization, engineering batches and stability, clinical and validation batches.
  • We offer all in-house validation support, from protocol design to execution, manufacturing, packaging and related processes.

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