mAb characterization workflows

Fluidics & Application Expertise to Develop Custom Solutions for Biopharma

Equipment manufacturers in the Biopharmaceutical fluidics space often struggle to find a simple workflow for characterizing biotherapeutic molecules and their production processes. Lack of real-time CQA/CPP data from cell culture process is a pain point that adds time and complexity to biotherapeutic drug development. This presents a massive challenge to the commercialization of the growing number of promising therapies in the development pipeline.

IDEX Health & Science is bridging the gap between the cell culture process and analytical instrumentation at all scales; from R&D to manufacturing. We partner with life science instrument manufacturers to develop innovative, consistent, and easy to integrate solutions for challenging analytical workflows in biopharma. From sample prep to detection, we have application expertise in chromatography, bioprocessing PAT, and related fluidics. How do you envision your analytical platform being deployed in a seamlessly integrated PAT environment? Partner with IDEX Health & Science to make your vision a reality and accelerate biopharmaceutical development together.

 

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Automated Calibration for mAb Titer

Calibration can be one of the most tedious steps in any analytical workflow. IDEX Health & Science can create integration-ready solutions to automate calibration for mAb titer workflows.

IDEX Health & Science Capabilities

  • Compact LED UV detection
  • Accurate fluid dispensing
  • Bioinert flow paths
  • Integration into OEM platforms

Key Benefits

  • Enables walkaway calibration for mAb quantification workflows
  • Simplifies real-time monitoring for process control and modelling

 

automated calibration for mAb titer

Simple fluidic subsystem for automated Protein A calibration

 

Cell Culture Media Analysis

Cell culture media analysis using CE-MS or LC-MS provides critical insight into cell health and productivity. IDEX Health & Science can create a pipette-free alternative to time-consuming manual precipitation dilution typically required for these methods.

IDEX Health & Science Capabilities

  • Accurate fluid dispensing
  • Custom valve design
  • Bioinert flow paths
  • Smart system feedback
  • Integration into OEM platforms

Key Benefits

  • Hands-free inline sample preparation
  • Simplifies real-time monitoring for process control and modelling
  • Environmentally friendly: 100% aqueous-based with no acetonitrile or harmful organic solvents

 

cell culture media analysis

Inline sample prep subsystem for cell culture media analysis

 

Smart Intact Mass Analysis

IDEX Health & Science can create custom subsystems to combine UV titer with intact mass analysis for a unified workflow. This is accomplished by an integrated buffer exchange procedure to prepare a sample for ionization in a mass spectrometer source.

IDEX Health & Science Capabilities

  • Custom valve design
  • Complete bioinert flow paths
  • Accurate fluid dispensing
  • Integration into OEM platforms

Key Benefits

  • Unified workflow for mAb product quantification and identification
  • Enables simpler GMP traceability

 

smart intact mass analysis

Buffer exchange for unified mAb titer and intact mass

 

mAb Sample Preparation

IDEX Health & Science can automate pipette-free, inline mAb sample prep for key workflows such as glycan analysis, peptide mapping, and multi-attribute methods (MAM). Our custom solutions can be tailored to any commercially available reagent kit including magnetic bead chemistry.

IDEX Health & Science Capabilities

  • Inline magnetic bead manipulation
  • Inline temperature-controlled reaction zones
  • Custom valve design
  • Bioinert flow paths
  • Integration into OEM platforms

Key Benefits

  • Walkaway automation of mAb sample prep
  • Eliminates human error caused by pipetting
  • Improves reproducibility
  • Enables online MAM workflows

 

mAb sample preparation

Inline solutions as a hands-free alternative to tedious pipette-based mAb sample prep workflows

 

Partner with Us

The analytical challenges of biological drug development are immense, but we can streamline your workflows, improve performance, provide consistency, and accelerate your time to market.

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