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Our work and case studies

Challenge:

To rapidly manufacture a GMP-compliant API-in-capsule product for use in Phase I and Phase II clinical trials.  The product was being investigated for treatments spanning multiple therapeutic areas.

Customer:

Japanese Speciality Pharma

Outcome:

Precision filling and dispensing of API into capsules was achieved using semi-automatic, automatic and robotic capsule filling equipment. Full QC Testing, QA release and QP certification, shipment service and CMC Dossier Compilation were completed by the Arcinova team to synergistically reduce project timelines.  Phase I and Phase II clinical trials were successfully implemented, exceeding clients predicted timelines by a factor of two.

 

Accelerated Development to Clinical Studies Rapid Manufacture - Precision Filling Case Study