High Touch Project Management
Process Development with ModularCMC™
ModularCMC™ streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.
CMC Development Services
Process Development
Every molecule presents specific manufacturing challenges; Wheeler applies scientific rigor and format-specific expertise to develop processes engineered for scale-up success.
Process Development and Optimization
From upstream optimization to downstream purification development, our data-driven methods ensure high yield, consistent quality, and an efficient path to manufacturing.
Fit-for-Purpose Development
Wheeler Bio’s approach to process development reflects the molecule. An extensive body of experimental data supports a platform process that most programs can apply without bespoke development.
For complex biologics such as multispecifics or Fc-fusion programs, format-specific downstream development can be designed around the molecule’s specific impurity profile.
For recombinant proteins requiring fully bespoke development, our scientific team designs upstream and downstream processes from the ground up.
End-to-end PD
Process development, engineered for your molecule’s formatUpstream PD
Process development, optimized for titer, quality, and reproducibility at scaleDownstream PD
Process development engineered for yield, purity, and clearance of product- and process-related impurities
Process Development Features
Process development encompasses a series of integrated, data-driven activities aimed at designing upstream and downstream workflows to ensure consistent product quality, scalability, and manufacturing robustness.
Optimization and/or Development of an inoculum expansion strategy for consistent, high-viability bioreactor inoculation
Systematic evaluation and optimization of basal and feed media compositions to enhance cell growth, metabolic performance, volumetric productivity, and alteration of post-translational modification (e.g., N-glycan) profiles
Systematic adjustment of key operating parameters, including pH, temperature, dissolved oxygen (DO), and agitation rate to modulate cell metabolism and tune and/or control product quality attributes
Development and optimization of intensified feeding strategies to maximize viable cell density and volumetric productivity
Development of clarification and downstream filtration operations, encompassing depth filtration, dead-end (intermediate) filtration, tangential flow filtration (TFF), viral nanofiltration, and terminal aseptic filtration
Automated, miniaturized screening of resin candidates and operating conditions using robotic liquid handling platforms to accelerate chromatographic process design and reduce material consumption
Design and optimization of chromatographic unit operations, including affinity, ion exchange (IEX), hydrophobic interaction (HIC), mixed-mode, and membrane-based modalities, for efficient product capture and polishing and clearance of product- and process-related impurities
Characterization of stability at key downstream unit operation intermediates to define acceptable hold times and conditions for process robustness
Development or optimization of viral inactivation (low pH or solvent/detergent), determination of viral filtration capacity, development of scale-down models for viral clearance studies, and management of viral clearance study execution
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A Partnership for Biologics Manufacturing Success
Ready to scale-up your antibody-based therapeutic? Contact us to learn how ModularCMC™ derisks the path to patients.