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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