James Humphrey | R&T Specialist
Croda
James has over 12 years’ experience focusing on the formulation sector. Working at Croda he has focused on formulating with Croda’s current range of surfactants, oils and other speciality chemicals used in formulated products from paints to pharmaceuticals to engine lubricants. James lead the new surfactant and formulation development teams, focusing on formulation science to develop new green and sustainable surfactants.
Appearances:
Festival of Biologics Day 1 @ 12:30
Optimising poloxamer 188 for CHO and HEK suspension cells for reduced batch-to-batch variation
The bioprocessing industry utilises Poloxamer 188 as a surfactant in parenteral biological formulations and as a shear stress protectant in cell culture. Poloxamer 188 is a non-ionic block copolymer with a hydrophobic polypropylene oxide (PPO) chain that is flanked by two hydrophilic polyethylene oxide (PEO) blocks. This unique molecular arrangement enables it to significantly reduce cell shear stress, which is essential for maintaining cell viability and overall health—a vital component in the successful production of biomolecules. However, the presence of impurities introduced during the manufacturing process can negatively compromise the functionality of Poloxamer 188 and adversely affect cell health, contributing to inconsistencies in performance between different production batches. Therefore, this inconsistency presents a persistent challenge in the bioprocessing market. As the demand for high-performance, batch-consistent cell culture ingredients continues to grow, Croda Pharma recently introduced Super Refined™ Poloxamer 188. Specifically optimised for cell culture, Super Refined™ Poloxamer 188 delivers excellent performance with tightly controlled impurity profiles, thereby reducing the risk of variable cell performance across different batches. To validate the efficacy of this innovative product, in this study we showed its exceptional performance in cell viability in both Chinese Hamster Ovary (CHO) and Human Embryonic Kidney (HEK) suspension lines. Furthermore, our study provides robust data that emphasises the batch-to-batch consistency of Super Refined™ Poloxamer 188, along with comprehensive analytical information that details its composition and impurity profile. As the need for reliability and batch-to-batch consistency of bioprocessing materials becomes increasingly evident, we believe Super Refined™ Poloxamer 188 will prove to be an exciting solution in this field.
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