- 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.