Gallus’ process development laboratories are designed to support development, technical transfer and optimization of processes and analytical methods for clinical and commercial production. Our process and analytical development group has extensive experience with various host cell types and manufacturing processes, as well as successful completion of multiple tech transfers and process optimization and development projects.
We have nearly three decades of experience in mammalian biopharmaceutical production, which gives us significant knowledge of cell culture processes and recombinant protein production. After a recent expansion, the St. Louis facility includes 9,000 square feet of laboratory space and support areas.
Cell Line Development
We offer 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 evaluation and selection
- Growth and titer assessments
- Product quality assessment
- Cell line comparibility
- Cell line characterization
- cGMP master/working/end of production cell bank manufacturing
Upstream Process Development
Gallus supports clients with significant commercial experience with cell culture bioreactor processes. We have developed capabilities for batch, fed-batch, and 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 (dissolved oxygen), 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
- ambr15TM automated single-use bioreactor system
- T-, spinner, and shake flasks, up to 20L wave bags
- 5L bioreactors
- 10L, 50L XcellerexTM and HyCloneTM single-use bioreactors
- 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’ antibodies and more complex non-antibody recombinant protein purification processes. This gives us the capability to design, develop, optimize and troubleshoot downstream processes with 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