Process Development

Visualizing your needs.

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

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 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
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
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
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