BIOPHARMA PEG Achieves FDA DMF Listings for Two PEG-Based Drug Conjugation Reagents

July 15, 2025

Watertown, MA July 16, 2025 BIOPHARMA PEG, a U.S.-based supplier of functional polyethylene glycol (PEG) derivatives for pharmaceutical applications, today announced that two of its specialized PEG reagentsmPEG-pALD (20K) and HZ-PEG-HZ (1K)have been officially registered with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF) system.

mPEG-pALD (20K) DMF No. 040600

HZ-PEG-HZ (1K) DMF No. 041864

These reagents are designed to support the growing needs of bioconjugation, controlled-release drug formulations, and advanced polymer-drug systems in both preclinical and clinical pipelines.

Enabling Next-Generation Drug Conjugates and Delivery Systems

The newly listed mPEG-pALD is a methoxy-terminated PEG bearing an aldehyde functional group, often used for site-specific protein and peptide conjugation. It offers controlled reactivity with amine-containing biomolecules, making it particularly useful in antibody-drug conjugate (ADC) technologies and PEGylated therapeutic platforms.

HZ-PEG-HZ is a homobifunctional PEG linker with hydrazide functional groups on both ends, enabling stable covalent coupling to carbonyl-containing targets. This reagent is frequently used in nanoparticle surface engineering, hydrogel networks, and targeted delivery constructs, where molecular architecture and linker uniformity are critical.

Regulatory Support for Biotech and Pharma

The FDA DMF listings provide manufacturers and developers with a secure regulatory reference for these materials, streamlining IND or NDA submissions and facilitating their integration into clinical manufacturing processes. BIOPHARMA PEG's DMF support aligns with its broader strategy to offer scalable, traceable, and high-purity PEG reagents for drug development workflows.

As the demand for well-characterized, regulatory-ready conjugation linkers continues to rise, our goal is to provide tools that meet both the scientific and compliance needs of our partners,said Dr. Jack, CEO from BIOPHARMA PEG.

About BIOPHARMA PEG

Headquartered in Watertown, Massachusetts, BIOPHARMA PEG specializes in the development and manufacturing of PEG linkers for the biopharmaceutical industry. Its product catalog includes monofunctional, bifunctional, and multi-arm PEGs, as well as custom linkers for ADCs, oligonucleotide delivery, and protein conjugation.

All products are manufactured under strict quality systems with scalability from milligram research-grade to GMP-compliant kilogram quantities.

To learn more, visit:

www.biochempeg.com  sales@biopharmapeg.com