Biopharma PEG, a leading developer and supplier of high-purity polyethylene glycol (PEG) derivatives, today announced that two of its proprietary products—mPEG-pALD 20K and HZ-PEG-HZ (1K)—have successfully passed FDA review and are now listed in the U.S. Drug Master File (DMF) database.
These new listings mark a significant step in Biopharma PEG’s ongoing efforts to provide regulatory-ready, high-quality PEG solutions to the global pharmaceutical and biotechnology industries.
“We’re proud to add these two products to our growing list of DMF-supported offerings,” said Sonia Lee, head of business development for Biopharma PEG. “Our mission has always been to enable the development of safer, more effective therapeutics by delivering reliable PEG materials that meet the highest quality standards.”
mPEG-pALD is a methoxy PEG-aldehyde derivative widely used in protein and peptide conjugation, controlled release formulations, and antibody-drug conjugate (ADC) development. Its high purity and consistent aldehyde reactivity make it a trusted component in bioconjugation and surface modification strategies.
HZ-PEG-HZ is a homobifunctional PEG derivative featuring terminal hydrazide groups. This versatile molecule is ideal for applications such as nanoparticle functionalization, hydrogel crosslinking, and polymer-drug conjugates, where stable and site-specific linkages are critical.
Both products are manufactured under stringent quality systems and are available from gram to kilogram scale, including GMP-compliant production upon request.
The addition of these DMF numbers enhances BIOPHARMA PEG’s ability to support pharmaceutical companies with the documentation needed for regulatory submissions, including IND and NDA filings. The company plans to continue expanding its DMF portfolio in response to growing client demand.
“Our clients rely on us not just for materials, but for peace of mind when it comes to documentation, traceability, and regulatory alignment,” Sonia added. “This milestone reflects our readiness to support drug developers from early research through to commercial launch.”
About Biopharma PEG
Headquartered in Watertown, MA, Biopharma PEG specializes in the design, development, and production of functional PEG derivatives used in drug delivery, bioconjugation, and advanced pharmaceutical materials. From monofunctional and bifunctional PEGs to multi-arm PEGs and customized linkers, the company supports a wide range of R&D and commercial projects with both standard and GMP-grade materials.
Biopharma PEG works with biotech startups, global pharmaceutical companies, and CDMOs around the world to deliver flexible, scalable PEG solutions tailored to modern drug development.
