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Mammalian Protein Process Development

Visualizing your needs.

Our goal is to ensure our clients receive a quality, scalable, and robust process that meets their expectations.

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Process Development Services

Our team is highly experienced in rapid technology transfer, process development and process characterization.  Our discovery, upstream, and downstream development processes are harmonized to ensure you receive a well-developed process and characterized biologic with consistent product quality.

  • Transient transfections
  • Clone selection / cell line stability
  • Manufacturability assessments
  • R&D material supply
  • 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 – 200 L)
  • Process characterization studies based on Design of Experiments and in-process control strategies creation
  • Harvest clarification development
  • Platform purification process for MAbs
  • Custom purification processes for unique, complex biologics
  • Chromatography steps with all modalities (affinity, ion exchange, mixed-mode, HIC, hydroxyapatite, size exclusion)
  • Membrane and depth filtration (all filter suppliers)
  • Viral inactivation (pH & Solvent/Detergent)
  • Concentration by UF/DF (all membrane suppliers)
  • Pre-clinical toxicology material production with pilot scale Akta system
  • Process characterization studies based on Design of Experiments and in-process control strategies creation

Cell Lines

  • Chinese Hamster Ovary
    • CHO-K1
    • CHO-DG44
    • CHO-GS
    • CHO-S
  • Murine
    • NS0
    • SP2/0
  • HEK293

Molecule Types

  • Monoclonal Antibodies
  • Bispecific Antibodies
  • Biosimilars
  • Complex Recombinant Proteins
  • Fusion Proteins
  • Fc Fusions
  • Vaccine Subunits
  • Enzymes

Production Modes

  • Batch
  • Fed-batch
  • Perfusion
  • Transient transfections
  • Clone selection / cell line stability
  • Manufacturability assessments
  • R&D material supply
  • 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 – 200 L)
  • Process characterization studies based on Design of Experiments and in-process control strategies creation
  • Harvest clarification development
  • Platform purification process for MAbs
  • Custom purification processes for unique, complex biologics
  • Chromatography steps with all modalities (affinity, ion exchange, mixed-mode, HIC, hydroxyapatite, size exclusion)
  • Membrane and depth filtration (all filter suppliers)
  • Viral inactivation (pH & Solvent/Detergent)
  • Concentration by UF/DF (all membrane suppliers)
  • Pre-clinical toxicology material production with pilot scale Akta system
  • Process characterization studies based on Design of Experiments and in-process control strategies creation

Cell Lines

  • Chinese Hamster Ovary
    • CHO-K1
    • CHO-DG44
    • CHO-GS
    • CHO-S
  • Murine
    • NS0
    • SP2/0
  • HEK293

Molecule Types

  • Monoclonal Antibodies
  • Bispecific Antibodies
  • Biosimilars
  • Complex Recombinant Proteins
  • Fusion Proteins
  • Fc Fusions
  • Vaccine Subunits
  • Enzymes

Production Modes

  • Batch
  • Fed-batch
  • Perfusion
Why does our process development team stand out?
  • Demonstrated expertise in cell culture development, with the proven ability to maximize productivity and guide glycosylation
  • World-class process development experience, with the know-how to provide the process steps to yield the highest productivity and product quality
  • A full spectrum of analytical capability, extensive experience and technical knowledge required to develop difficult assays, including live-cell assays
  • Extensive experience to scale-up and transfer to CGMP manufacturing
Upstream Equipment Capabilities
Upstream
Ambr® 250
Upstream
24x Sartorius B-DCU bioreactor controllers​
Upstream
6x Sartorius B-DCU II bioreactor controllers​
Upstream
50 L Mobius SUB pilot scale bioreactor
Upstream
100 L ThermoFisher SUB pilot scale bioreactor
Upstream
200 L Mobius SUB pilot scale bioreactor
Upstream
50/200 Sartorius STR pilot scale bioreactors
Upstream
2x Millipore Millistack+ depth filtration pilot scale holders
Upstream
Nova 400 metabolite profiler
Upstream
Nova Flex2 metabolite profiler
Upstream
2x Vi-Cell XR cell counters
Upstream
Wave bioreactor system
Downstream Equipment Capabilities
Downstream
TECAN Fluent® 1080
Downstream
2 Akta Avant 150 systems
Downstream
1 Akta Pure 150 system
Downstream
3 Akta Explorer 100 systems
Downstream
1 Akta Pilot system
Downstream
Repligen KrosFlo KR2i TFF system
Next Up →
Mammalian Protein CGMP Manufacturing
Explore the full lifecycle capabilities that help our clients take their concept to commercial success.