All4Nutra
Parenteral grade surfactant designed for stabilizing biologic formulations
Biologic formulations require the most stringent requirements to be met in order to ensure patient safety and the optimal performance of the drug. Poloxamer 188 has a long history of use in approved and marketed biologic drugs such as antibodies, therapeutic proteins, and gene therapy products. It is a stabilizing surfactant that protects the active ingredient from damage caused by environmental stresses.
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With over 50 years of experience in poloxamer chemistry, BASF is committed to providing Kolliphor® P188 Bio, which is a high purity poloxamer 188 designed to meet your needs in quality, consistency, and performance in the formulation of parenteral biologic drugs including antibodies, therapeutic proteins, gene therapies, and vaccines.
Get your sample of Kolliphor® P188 Bio here!
- History of prior use in approved parenteral biologic formulations
- Manufactured in the USA according to cGMP
- Consistent performance and higher purity lowers manufacturing risks
- Enhanced packaging and testing to meet the needs of biopharma manufacturing
- Compendial grade with GMP documentation and Drug Master File
Why use Kolliphor® P188 Bio instead of other poloxamer 188 grades?
- Designed specifically for the biopharma industry
- Higher purity improves consistency and reduces manufacturing and safety risks
- Superior packaging meets manufacturing requirements
Product Details
Manufacturing Standard: Produced in the USA in accordance with IPEC-PQG GMP Guide for Pharmaceutical Excipients and 21 CFR Parts 210/211
cGMP Quality: cGMP
Monograph Quality: Ph. Eur., USP, JPE
Documentation: COA, Drug Master File, Third-party Audit Report, additional regulatory documents
Packaging: 500 g samples. 5 kg, 12.5 kg, 25 kg, 102 kg. In HDPE drums. Double PE liners. Tamper-evident seals
Validated Cleaning Process: Stringent controls for highest purity
Quality Tests: Endotoxin. Total yeast and mold count (TYMC). Total aerobic microbe count (TAMC). Analytical chemistry analysis
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