Gallus currently has five commercial manufacturing suites at its St. Louis facility, with significant room for further build-out. All suites are designed to offer flexibility, with portable equipment from 500 L to 2,000 L bioreactor scale. Clients have the option of state-of-the-art fully disposable or flexible stainless steel equipment, and manufacturing capabilities for mammalian cell culture and protein purification in perfusion or fed batch.
With the flexibility of portable equipment and the space we have available, Gallus offers the opportunity to design and build a substantial number of new suites configured to a client’s needs.
Suites 1 and 2
These suites measure 1,100 square feet each, and support upstream commercial operations using up to three 500 L perfusion bioreactors per suite. They are configured to support all processing, from inoculum to the first capture step.
Suite 3
This suite also measures 1,100 square feet, and is isolated by a separate airlock. It can be converted for either upstream or downstream operations.
Commercial cGMP Suites 1, 2 and 3
Suite 4
Suite 4 has capabilities for both stainless steel (4 X 500 L) and single-use bioreactors (2 X 2,000 L). Suites 1–4 are dedicated to late stage and commercial manufacturing.
This suite measures approximately 2,000 square feet and serves late-stage Phase III to commercial capabilities at 2,000L fed-batch cell culture and downstream processing scale. The cell culture area supports two 2,000 L single-use bioreactors for optimal versatility in this suite. Support rooms associated with this suite include inoculum preparation, a cell culture/harvest room, and two downstream processing rooms. The flow of material and personnel flows in Suite 4 is unidirectional and utilizes shared airlocks. The inoculum and downstream processing rooms are classified ISO-7 and the cell culture/harvest rooms is classified ISO-8.
Commercial cGMP Suite 4 configured with 2 x 2,000 L bioreactors
Commercial cGMP Suite 4 configured with 3 x 500 L perfusion bioreactors
St. Louis Single-Use Technology Suite (Suite 5)
Gallus’ Suite 5 in St. Louis covers 8,000 square feet utilizing a ballroom configuration and was specifically designed with a high degree of flexibility. It utilizes state-of-the-art single-use and multiple 50 L – 2,000 L scale equipment for the production of clinical material in Phase I/II/ III and commercial manufacturing.
The suite encompasses media and buffer formulation, cell culture and downstream purification operations, and all necessary support functions including media and buffer preparation areas. Suite 5 is designated as an ISO-8 ballroom containing an ISO-7 inoculum and bulk fill room incorporating once-through air and access through an airlock. All personnel and equipment flow is designed to be consistent with cGMP requirements.
Suite 5 houses an Xcellerex® FlexFactory® comprising 50 L, 500 L and 2,000 L single-use bioreactors. There are also ISO 7 Controlled Environment Modules (CEM) – effectively equipment-only clean rooms – for harvest POD filtration, virus inactivation, chromatography, tangential flow filtration, and bulk filling.
In addition, we have a number of support rooms directly adjacent and accessible to the main production areas. These comprise a column storage cold room (2-8ºC), analytical at line laboratory, an equipment storage and staging room, a glass wash room, clean equipment storage room, and a column packing room.
Equipment
- 50 L, 500 L and 2000 L bioreactors
- Multiple-unit operation downstream processing
- Harvest POD filtration CEM
- Virus inactivation skid CEM
- Chromatography-ready CEMs
- Tangential flow filtration CEM
- Bulk-fill CEM
Single-Use Technology Suite 5
For more information on how Gallus utilizes the GE Healthcare Life Sciences FlexFactory™, watch this short video: