Kolliphor® P 188 Bio – High purity poloxamer designed to reduce shear stress during biologics manufacturing
Cell cultures used in biologic manufacturing have stringent requirements that must be met in order to ensure high cell viability and consistent biologic drug yield. For protection from shear stress, poloxamer 188 has a long publication history as well as documented use in the manufacturing of approved biologics. With over 50 years’ experience in EO/PO chemistry, BASF is committed to providing the poloxamer Kolliphor® P 188 Bio, which is designed to meet your needs in quality, consistency, and performance.
Manufacture of biologics in suspension cell culture causes damage to the cell membranes (shear stress). The majority of the damage occurs due to agitation from the impellor, and during gas sparging at the bubble layer, regardless of the bioreactor size that is used. Damaged cells in the culture lowers the overall health of the culture, and will ultimately affect the protein production yield. Many different compounds have been screened for use in protecting the cells from this shear stress, including animal serum, cellulosic derivatives, dextran sulfate, polyethelyne glycols (PEGs), polyvinyl alcohol (PVA) and poloxamers. The most widely used additive to protect against shear stress is poloxamer 188 (P 188, often referred to as Pluronic® F-68). Impurities present in poloxamer 188 preparations can have toxic effects on the cell culture, so it is very important to use the most pure and consistent poloxamer 188 available – Kolliphor® P 188 Bio, which has been designed for use in cell culture systems.
Other grades of poloxamers (including Pluronic® F-68) do not have the consistency and purity required to maintain the health and production capacity of mammalian cells in culture for protein and biologic drug production. Poloxamer 188 has been extensively researched and has been found to be the most effective additive to provide shear protection during manufacturing of biologic drugs in mammalian expression systems.
Why choose Kolliphor® P 188 Bio
- Consistent performance lowers manufacturing risk
- Additional cell culture & analytical testing
- Packaging in plastic drums with double PE liners
- Meets Ph. Eur, USP/NF, and JPE Compendia
- Drug Master File reference
|Chemical name||Poloxamer 188|
|Regulatory Status||Meets Ph. Eur, USP/NF, and JPE Compendia|
|Applications||Poloxamer Kolliphor® P188 Bio is designed to meet your needs in quality, consistency, and performance for cell culture systems|