Roquette: Bringing New Solutions for Biotherapeutics
Protein stabilization is a critical challenge facing biotherapeutic formulators due to a multitude of destabilizing forces and pathways. The complexity and natural propensity of proteins to aggregate pose a challenge at every stage of drug development.
Throughout the manufacturing and storage process, protein stability is affected by multiple stress factors. Each stressor can contribute to physical degradation, protein misfolding/unfolding, and aggregation. Protein aggregates reduce therapeutic efficacy, and can potentially induce unwanted immunogenicity, causing harm to patients. A delicate balance between protein structural stability and native conformation flexibility must be achieved to deliver a safe and efficacious biologic drug.
Using a high-throughput formulation screening method iFormulateTM (a registered trademark of HTD Biosystems Inc.) paired with nanoDSF (Differential Scanning Fluorimetry), we investigated the stabilizing effects of KLEPTOSE® HPB and HP on the thermal stability of the human growth hormone (hGH) and the monoclonal antibody (mAb) Infliximab. The iFormulateTM Design of Experiment (DOE) approach provided a rapid evaluation of four critical formulation variables: pH, ionic strength, buffer concentration, and stabilizer concentration. Simultaneous evaluation of Tm (melting temperature) and relative degree of aggregation was performed.
The DOE study results demonstrated that both Hydroxypropyl Beta Cyclodextrins are efficient aggregation modulators. Roquette’s KLEPTOSE® HPB and HP grades, show promise as multifunctional excipients suitable for biopharmaceutical applications.
Stop by booth No. 1007 at CPhI North America (April 24-26) in Philadelphia to learn more! For more information online, visit www.roquette.com/pharma/.
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