Seppic, a recognized manufacturer of pharmaceutical excipients, expands its portfolio of injectable surfactants with the launch of MONTANOXTM 20 HPB. Unveiled at the CPHI World Pharmaceutical Exhibition in Milan, this new high-purity non-ionic polysorbate has been developed for the formulation of biological drugs.
Manufactured from living cells or organisms, biologics such as monoclonal antibodies and hormones are experiencing significant growth worldwide and are expected to grow at an average annual rate of over 10%1,2 in the coming years
These innovative medications are used to treat various pathologies such as cancers, diabetes or arthritis with more targeted and tailored treatments.
Biopharmaceuticals present many advantages but also formulation challenges. To maintain their full efficacy, biological active ingredients, which are more complex than those derived from chemistry, need to be stabilized in solution using specific excipients.
In response to this problem, Seppic has developed Montanox™ 20 HPB, a high purity polysorbate 20 suitable for the most sensitive active ingredients. Its formula is tailored to the needs of biopharmaceutical formulators with stricter specifications on fatty acid distribution to minimize the risk of active ingredient degradation, offering improved bioavailability, stability and formulation protection. This product thus complements Seppic’s Montanox™ injectable polysorbate range, used to solubilize active pharmaceutical ingredients and formulate oil-in-water emulsions.
This new Montanox™ 20 HPB grade, like all products in the range, complies with the most stringent quality standards applied to active pharmaceutical ingredients. It complies with Good Manufacturing Practice (GMP Part II) and current Pharmacopeias in force (EP, USP-NF, JP, CHP).
Hocine NOUARI, Injectables Market Manager at Seppic, commented: “The launch of this new, high value-added HPB reference is a significant innovation in Seppic’s injectable surfactants sector. It marks our determination to develop ever more specific and qualitative ingredients for rapidly expanding markets such as the biologics market.”
