GMP Stability Studies and Storage
MABION provides GMP stability studies to support our customers’ drug development and clinical trials for estimation of shelf-life. The stability group undertakes the stability studies for API, intermediates, drug product, placebo and reference standard.
The services include:
– Real time, long term stability studies
– Forced degradation studies
– Initial testing of stability indicating methods
– Freeze-thaw stability studies
– Shipment simulation studies
– Clinical Trial in-use simulation studies
Each study is individually designed to meet specific customer needs. Stability studies may either be developed individually or follow guidelines and covers the complete service from the stability protocol to the stability report.
We provide secure storage and testing of your samples according to client specified procedures and timetables. Our capabilities include full characteristics of the product – bioassays, physicochemical and microbiological testing services and support for your biopharmaceutical product in a GMP/GLP laboratory.