Process Development

Gallus has been producing mammalian biopharmaceutical products for the last 26 years and has significant experience with mammalian cell culture processes and recombinant protein production. The Gallus process development laboratories are designed to support development of early-phase processes, as well as for technical transfer and troubleshooting of processes for clinical and commercial production. The facility contains 6,000 square feet of laboratory space and laboratory support areas. The process development group has considerable capabilities with a variety of host cell types and manufacturing processes, which, when combined with its significant commercial manufacturing experience, gives Gallus clients confidence that an appropriate manufacturing process can be developed and, ultimately, used for commercial production.

Cell Line Development

Gallus offers mammalian cell line development capabilities and can work with most commercial recombinant mammalian cell lines to assist clients with final cell line selection, comparability assessments and cell line characterization.

Services

• Cell Line Selection
• Growth and titer assessments
• Integration of analytics for product quality assessment
• Cell Line Comparisons/Assessments/Characterization
• Cell Line Stability
• Media evaluation/comparison

Upstream Process Development

Gallus brings significant commercial experience with cell culture bioreactor processes to client products and has development capabilities for batch, fed-batch, or perfusion upstream process platforms.

Services

• Batch, fed-batch, or perfusion process development
• Seed train/inoculum development
• Media optimization
• Basal, feed
• Critical parameter control definition
• pH, temperature, DO, seeding density, viability, cell density, titer
• Harvest/primary recovery method development
• Perfusion Methods with Centrifugation, Cell Settling Devices, ATF (Alternating Tangential Flow), Internal Spin Filter
• non-cGMP protein production – up to 50L

Methods/Equipment

• T-, spinner, and shake flasks, up to 20L wave bags
• 14 x 5L bioreactors
• 8 x 10L, 1 x 50L Xcellerex disposable bioreactors
• 1 X 50L stainless steel bioreactor
• Perfusion – centrifugation, cell settling devices, ATF, Internal Spin Filter
• Harvest by filtration or centrifugation

Purification Process Development

Gallus has commercial experience with both "platform-type" antibody and more complex non-antibody recombinant protein purification processes; thus, the capabilities to design, develop, optimize or troubleshoot downstream processes incorporating a variety of approaches.

Services

• Protein purification development/optimization
• Process transfer
• Scale-up
• non-cGMP protein production – up to 50L
• Viral clearance – inactivation and clearance

Methods/Equipment

• Protein A, other affinity capture chromatography
• Ion exchange, hydrophobic interaction, mixed mode chromatography
• Filtration – UF/DF, depth, nanofiltration
• AKTA chromatography systems
• In-lab analytical assay capabilities for fast turn-around