Gallus offers cGMP stability testing and cGMP product storage to clients for testing stability of intermediate hold times and shelf life of drug substance, drug product, placebo and reference standard. Combining these studies with our client’s process development and manufacturing program at Gallus offers them convenience and cost savings through utilization of their established and qualified / validated methods, rather than having to establish these assays at another contractor.
Stability studies are typically designed according to ICH guidelines and Gallus has temperature and humidity-controlled and monitored storage chambers.
Services
- Real time, accelerated, and stressed stability studies
- Identification and development of stability indicating methods
- Protocol, report and BLA-ready table generation
- ICH and non-ICH conditions available
- Forced degradation
- Freeze-thaw studies
Equipment
- Ultrafreezers (-190°C, -80°C)
- Freezers (-20°C, -40°C, -70°C)
- Refrigerators (2-8°C)
- Stability chambers (25°C/60% humidity, 40°C/75% humidity)
cGMP Cell Banking and Storage
Gallus offers cGMP mammalian cell bank manufacture on an integrated basis as part of a comprehensive process development and manufacturing project.
Services
- Master cell bank and working cell bank cGMP manufacture
- Cell bank cGMP storage
The cell banking process is conducted in an ISO-7 suite with dedicated air handling designed for this purpose. It utilizes state-of-the-art equipment to ensure vial-to-vial consistency. The ISO-7 suite is independent from the production facility and more closely integrated with the process development lab, which ensures enhanced segregation of cell lines and products.
At the beginning of the process, Gallus works closely with the client to manufacture master and working cell banks. Manufacturing takes place in a GMP environment using a state-of-the-art filling apparatus specifically designed for the production of cell banks. This automated method enables rapid creation of a cell bank in a format that has minimized direct operator interventions and maximized product protection.
A disposable sterile flow path and peristaltic transfer mean that uniform cell dispensing is performed quickly. Filled cryovials are rapidly transferred into controlled rate freezing for maximum stability. Gallus provides a Certificate of Compliance and Certificate of Analysis as appropriate.