Aseptic Fill & Finish
At Althea, we can design, set-up, and manage stability studies that follow ICH compliant protocols. Our stability capabilities are in master and working cell bank characterization, method transfer and optimization, long-term stability studies, and accelerated stability studies.
With our comprehensive stability program capabilities, we can design, or help you design, a stability study that is appropriate for your protein and stage of clinical testing. This design includes everything from frequency of testing and choice of temperatures to identification of appropriate stability-indicating assays and stability-limiting product degradations.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.