- Gannet BioChem has filed a Type II Drug Master File (DMF) for PEG propionaldehyde 20K under its Arab, Alabama facility to support pegfilgrastim biosimilar development.
- The activated polymer is used for protein modification to improve solubility, stability, and pharmacokinetics in PEGylated therapeutics.
Gannet BioChem has filed a Type II Drug Master File (DMF) under its Arab, Alabama facility (FEI 3006223361) for PEG propionaldehyde 20K. The filing supports the development and commercialisation of pegfilgrastim biosimilars. The company operates in life sciences manufacturing and supplies activated polymers used in pharmaceutical development.
The PEG propionaldehyde 20K material is an activated polymer used to modify proteins. According to the company, the component enables improvements in solubility, stability, and pharmacokinetics in PEGylated therapeutics.
The DMF filing is intended to support programmes developing biosimilar versions of pegfilgrastim. The product is manufactured at the company’s facility in Arab, Alabama in the United States.
Gannet BioChem stated that it has supported nine commercial PEGylated therapies through its PEG reagent supply and has partnered with more than 50 organisations involved in preclinical and clinical development. The company said it maintains a 100 per cent on-time, in-full delivery record for PEG reagent manufacturing programmes supported by its scientific team.
“I am pleased with the strong progress following our acquisition of Laysan Bio earlier this year. This filing supports a fully compliant, US-based supply of critical components that enable the development of more affordable medicines, addressing infection risks for patients undergoing chemotherapy.”
Nicholas Shackley, Chief Executive Officer of Gannet BioChem
