Gannet BioChem Files Type II Drug Master File for mPEG Propionaldehyde 20K to Support Pegfilgrastim Biosimilars
HUNTSVILLE, Ala., March 10, 2026 (GLOBE NEWSWIRE) — Gannet BioChem, a leading life sciences manufacturing company, today announced that it has filed a Type II Drug Master File under its Arab, AL facility (FEI 3006223361) for its PEG propionaldehyde 20K, to support the development and commercialization of pegfilgrastim biosimilars.
mPEG propionaldehyde 20K is an activated polymer and is a critical component enabling protein modification to improve solubility, stability, and pharmacokinetics.
Gannet BioChem has supported nine commercial PEGylated therapies through its PEG reagent supply and partnered with more than 50 organizations across preclinical and clinical development. The company maintains a 100 percent on-time, in-full delivery record for PEG reagent manufacturing programs and is supported by a tenured scientific team that provides long-standing project continuity. Together, these capabilities enable the consistent supply of high-quality PEG reagents used in PEGylated therapeutics, including biosimilar pegfilgrastim.
Nicholas Shackley, Chief Executive Officer, said “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.”
Gannet BioChem will be attending DCAT Week on March 23-26 in New York, where members of the leadership team will be available to meet with partners and discuss the company’s expanding capabilities in activated polymer development and manufacturing for therapies, biosimilars, medical devices, and diagnostics.
About Gannet BioChem
Gannet BioChem is a leading specialty CDMO focused on the development, scale-up, and manufacturing of activated polymers, including polyethylene glycol (PEG) reagents, which are critical components used in advanced biopharmaceutical, therapeutic, and medical device products. With more than 30 years of industry expertise, the company provides high-quality activated polymers, including PEG reagents, and related services to support customers from early development through commercialization. Following the acquisition of Laysan Bio, Gannet BioChem expanded its capabilities to include both catalog and custom activated polymer products, strengthened technical support, and increased manufacturing capacity. The combined organization operates FDA-inspected and registered facilities in Huntsville and Arab, Alabama, offering flexible production from gram-scale development through cGMP manufacturing for clinical and commercial supply. With a highly experienced scientific team, rigorous quality systems, and a strong track record supporting FDA, EU, and other regulatory agency approvals. Gannet BioChem delivers reliable, scalable solutions to meet the evolving needs of the global biopharmaceutical industry. For additional information, please visit GannetBioChem.com or follow us on LinkedIn.
SOURCE: Gannet BioChem
CONTACT: Gannet BioChem (256) 512-9200 [email protected]
