Does the new poloxamer provide any other benefits beyond protection from shear or cause any issues that users should be aware of?
This question is part of the following Ask The Expert session:
Addressing Shear Stress in Bioreactors
Answered by:
Company: Merck
Job Title: Head of Perfusion Systems Lab, Life Science, BioProcessing R&D,
Answer
To develop a product with consistent quality and proven functionality in upstream processes was our main objective when starting the project as this was a real pain point in the industry. Nevertheless we see our reliable supply (large manufacturing capacities in Europe) and the transparency we offer with our Emprove® dossiers as other benefits beyond protection from shear. The Emprove® Program is known for outstanding quality with comprehensive documentation. Each product in the portfolio is complemented with three types of dossiers to help facilitate qualification, risk assessment and process optimization efforts: Material Qualification Dossier, Quality Management Dossier and Operational Excellence Dossier. They provide information on the manufacturing process, stability data, elemental impurity information, product quality reports, analytical procedures, supply chain, and much more.