Head of Development BASF SE Ludwigshafen, Rheinland-Pfalz, Germany
Today, three surfactants are used for the stabilization of antibody formulations. Polysorbate 80, Polysorbate 20 and Poloxamer 188. Poloxamer 188 is effective at slightly higher concentrations than polysorbates but has the advantages of a more defined composition and better stability. However, in the presence of silicon oil, Protein-PDMS particles were detected after long-term storage for some protein formulations [1]. It was observed that certain Poloxamer 188 lots that contained more hydrophobic species, were more effective stabilizers. [2,3]. A more hydrophobic poloxamer 188 variant can be more suitable for the formulation of biologics, especially when the formulation is filled in primary packaging with PDMS. Our study shows that less protein was adsorbed on PDMS surfaces after pre-coating with a hydrophobic P188 variant and fewer subvisible particles were formed after stress induction.
Learning Objectives:
Upon completion, participants will be able to understand how a more hydrophobic poloxamer 188 variant that complies with the specification of the Pharmacopoeia Monograph helps to stabilize biologics formulations
Upon completion, participants will be able to understand why a more hydrophobic poloxamer 188 variant can be beneficial for biologics formulations, especially when filled in primary packaging with PDMS
Upon completion, participants will be able to discuss the impact of poloxamer variability on biologics formulations.
