MAMMALIAN PROTEIN PROCESS DEVELOPMENT
Meeting your needs while exceeding your expectations.
We work with you to ensure a robust, high-quality, scalable process from start to finish.
Process Development Services
Our team brings extensive expertise in rapid technology transfer, process development, and process characterization. With fully integrated upstream and downstream development workflows, we deliver seamless, well-optimized processes that ensure your biologic is thoroughly characterized and consistently meets the highest quality standards.
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Cell Lines, Molecules, & Production Modes
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Instrumentation
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Upstream Process Development & Optimization
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Downstream Process Development & Optimization
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Why does our process development team stand out?
Cell Lines
- CHO
- K1
- DG44
- GS
- S
- Murine
- NS0
- SP2/0
- HEK293
Molecule Types
- Monoclonal Antibodies
- Bispecific/Multispecific Antibodies
- Biosimilars
- Complex Recombinant Proteins
- Fusion Proteins
- Fc Fusions
- Vaccine Subunits
- Enzymes
Production Modes
- Batch
- Fed-batch
Upstream
- Ambr® 250 24-Way
- Single-Use Centrifuge
- 24x Sartorius B-DCU Bioreactor Controllers
- 100L Thermo Fisher SUB Pilot Scale Bioreactor
- 4x Millipore Millistak+® Depth Filtration Pilot Scale Holders
- 3M Depth Filtration Pilot Scale Holder
- 3x Nova FLEX2 Bioanalyzers
- 2x Vi-CELL XR Cell Counters
- 2x Vi-CELL BLU Cell Counters
- 2x Cytiva WAVE™ Bioreactor System
Downstream
- 3x ÄKTA Avant™ 150 Systems
- 5x ÄKTA Pure™ 150 Systems
- 1x ÄKTA Pilot™ System
- 1x ÄKTA Ready™ Gradient System
- 2x Repligen KrosFlo® KR2i TFF System
- 1x Repligen KrosFlo® KMPi TFF System
- Platform upstream process for MAbs
- Rapid process development and improvement (inoculum and seed train, basal and feed media, production bioreactor cell culture process)
- Fed-batch and perfusion-based processes
- Pre-clinical toxicology material production in pilot-scale bioreactors (50–100L)
- Process characterization studies based on Design of Experiments and in-process control strategies creation
- Harvest clarification development
- Depth filtration and single-use centrifugation
- Platform purification process for MAbs
- Custom purification processes for unique, complex biologics
- High-throughput resin screening and process parameter optimization using Tecan Chromatography steps with all modalities (affinity, ion exchange, mixed-mode, HIC, hydroxyapatite, size exclusion)
- Membrane and depth filtration (all filter suppliers)
- Viral retention filtration
- Viral inactivation (pH & solvent/detergent)
- Concentration by UF/DF (all membrane suppliers)
- Pre-clinical toxicology material production with pilot scale ÄKTA system
- Process characterization studies based on Design of Experiments and in-process control strategies creation
- Demonstrated expertise in cell culture development, with the proven ability to maximize productivity and guide glycosylation
- State-of-the-art downstream process development facility offering fast, successful process development and transfer
- World-class process development experience, with expertise to yield the highest productivity and product quality
- Extensive experience to scale up and transfer to CGMP manufacturing
Cell lines, Molecules & Production Modes
Cell Lines
- CHO
- K1
- DG44
- GS
- S
- Murine
- NS0
- SP2/0
- HEK293
Molecule Types
- Monoclonal Antibodies
- Bispecific/Multispecific Antibodies
- Biosimilars
- Complex Recombinant Proteins
- Fusion Proteins
- Fc Fusions
- Vaccine Subunits
- Enzymes
Production Modes
- Batch
- Fed-batch
Instrumentation
Upstream
- Ambr® 250 24-Way
- Single-Use Centrifuge
- 24x Sartorius B-DCU Bioreactor Controllers
- 100L Thermo Fisher SUB Pilot Scale Bioreactor
- 4x Millipore Millistak+® Depth Filtration Pilot Scale Holders
- 3M Depth Filtration Pilot Scale Holder
- 3x Nova FLEX2 Bioanalyzers
- 2x Vi-CELL XR Cell Counters
- 2x Vi-CELL BLU Cell Counters
- 2x Cytiva WAVE™ Bioreactor System
Downstream
- 3x ÄKTA Avant™ 150 Systems
- 5x ÄKTA Pure™ 150 Systems
- 1x ÄKTA Pilot™ System
- 1x ÄKTA Ready™ Gradient System
- 2x Repligen KrosFlo® KR2i TFF System
- 1x Repligen KrosFlo® KMPi TFF System
Upstream Process Development & Optimization
- Platform upstream process for MAbs
- Rapid process development and improvement (inoculum and seed train, basal and feed media, production bioreactor cell culture process)
- Fed-batch and perfusion-based processes
- Pre-clinical toxicology material production in pilot-scale bioreactors (50–100L)
- Process characterization studies based on Design of Experiments and in-process control strategies creation
- Harvest clarification development
- Depth filtration and single-use centrifugation
Downstream Process Development & Optimization
- Platform purification process for MAbs
- Custom purification processes for unique, complex biologics
- High-throughput resin screening and process parameter optimization using Tecan Chromatography steps with all modalities (affinity, ion exchange, mixed-mode, HIC, hydroxyapatite, size exclusion)
- Membrane and depth filtration (all filter suppliers)
- Viral retention filtration
- Viral inactivation (pH & solvent/detergent)
- Concentration by UF/DF (all membrane suppliers)
- Pre-clinical toxicology material production with pilot scale ÄKTA system
- Process characterization studies based on Design of Experiments and in-process control strategies creation
Why does our process development team stand out?
- Demonstrated expertise in cell culture development, with the proven ability to maximize productivity and guide glycosylation
- State-of-the-art downstream process development facility offering fast, successful process development and transfer
- World-class process development experience, with expertise to yield the highest productivity and product quality
- Extensive experience to scale up and transfer to CGMP manufacturing
Offering a state-of-the-art process development facility.
Offering a state-of-the-art process development facility.
Mammalian Protein CGMP Manufacturing
Explore the full lifecycle capabilities that help our clients’ concepts reach commercial success.
Mammalian Protein CGMP Manufacturing
Explore the full lifecycle capabilities that help our clients’ concepts reach commercial success.