Kolliphor® P 188 Bio

Description

BASF’s Kolliphor P grade poloxamers are white, coarse – grained powders with a waxy consistency. They contain an appropriate quantity of the antioxidant BHT. Poloxamers are ABA-type co-polymers of poly (ethylene oxide) (PEO=A) and poly (propylene oxide) (PPO=B). The approximate relative amount of PEO and the average molecular weight of the PPO are indicated in the name of the poloxamer. For example, P 188 succeeding the word Kolliphor® indicates a poloxamer with ca. 80% m/m PEO(P 188; 8×10= 80%) and approximately average molecular weight of PPO of 1800
(P 188; 18×100= 1800).

Kolliphor® P 188 Bio & Kolliphor® P 188 Cell Culture are designed for protection against shear stress in biologic drug manufacturing processes. It is also suitable as an excipient for parenteral formulations. Improvements in the manufacturing process and a validated RP-HPLC assay ensures the highest quality product for consistent performance and less variability versus other poloxamer 188 grades.

 

Kolliphor® P 188 BIO is supplied as white to slightly yellowish, coarse grained powder with a waxy consistency. It is freely soluble in ethanol, freely soluble in water (opalescent solution), and is insoluble in diethyl ether, paraffin and fatty oils.

• Consistent performance lowers manufacturing risk
• Additional cell culture & analytical testing
• Enhanced packaging

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.