Huateng Pharma has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for our self-developed HZ-PEG-HZ (1K) product (DMF number: 041864). This significant milestone not only demonstrates our company's strong R&D capabilities in high-quality PEG derivatives but also provides reliable and compliant product support to pharmaceutical companies worldwide.
Product Information
Hydrazide-PEG-Hydrazide (HZ-PEG-HZ) is a bifunctional polyethylene glycol (PEG) derivative with hydrazide (-CONHNH₂) groups at both ends of the polymer chain. This compound combines the well-known biocompatibility and solubility of PEG with the chemical versatility of hydrazide groups, making it a valuable reagent for a wide range of biomedical and pharmaceutical applications.
Structure: H₂N-NH–PEG–NH-NH₂
Available Molecular Weights: Typically 1,000 to 20,000 Da
Solubility: Soluble in water and most polar organic solvents
Reactivity: The hydrazide groups readily form hydrazone linkages with aldehyde and ketone groups under mild aqueous conditions.
Applcations
1. Protein and Peptide PEGylation
HZ-PEG-HZ enables selective PEGylation of proteins and peptides, often at the N-terminus. It reacts through various strategies, including oxidation of glycoprotein carbohydrate moieties or periodate oxidation of terminal serine/threonine residues. PEGylation enhances protein solubility and stability, lowers immunogenicity, and significantly extends circulation half-life in vivo.
2. Targeted Drug Delivery
Hydrazone bonds formed by HZ-PEG-HZ are stable at neutral pH but cleave under acidic conditions, such as those found in endosomes, lysosomes, or tumor microenvironments. This pH-sensitive behavior allows for the controlled release of drugs in targeted tissues, minimizing systemic exposure and side effects. It is particularly useful in designing smart delivery systems and nanoparticle-drug conjugates.
3. Bioconjugation and Crosslinking
As a bifunctional linker, HZ-PEG-HZ facilitates the conjugation of biomolecules, including proteins, peptides, and antibodies. It is widely used in constructing antibody-drug conjugates (ADCs), diagnostic tools, and imaging agents. Its reversible linkage capability supports applications that require controlled detachment or stimulus-responsive release.
4. Nanotechnology and Surface Engineering
HZ-PEG-HZ is employed in the functionalization of nanoparticles and solid surfaces to enhance biocompatibility and minimize non-specific binding. This makes it useful in applications such as cell culture systems, biosensors, and the development of advanced materials with tailored biological interfaces.
Conclusion
Hydrazide-PEG-Hydrazide is a highly versatile PEG derivative that plays a critical role in bioconjugation chemistry and drug delivery research. Its ability to form pH-sensitive hydrazone bonds, coupled with the advantages of PEGylation, positions it as a powerful tool in the development of next-generation therapeutics, diagnostics, and materials. As the demand for targeted and responsive delivery systems grows, HZ-PEG-HZ is expected to remain at the forefront of innovation in biomedical science.
The successful filing of our DMF with the FDA demonstrates that Huateng Pharma's manufacturing processes and quality control systems adhere to the highest international standards and regulatory requirements. This achievement provides enhanced protection and greater convenience for all our customers in their research and clinical applications.
Huateng Pharma remains committed to delivering high-quality, reliable PEG products and exceptional customer service. We will continuously strive to improve all aspects of our operations, including product research and development, Good Manufacturing Practices (GMP) compliant production and quality release, and comprehensive customer support. Contact us at sales@huatengusa.com if you are interested.
References:
[1] Hydrazide Derivatives of Poly(ethylene glycol) and Their Bioconjugates, Samuel Zalipsky and Sunitha Menon-Rudolph, Poly(ethylene glycol). August 5, 1997 , 318-341, DOI:10.1021/bk-1997-0680.ch021
[2] Li, C., Li, T., Tian, X., An, W., Wang, Z., Han, B., Tao, H., Wang, J., & Wang, X. (2024). Research progress on the PEGylation of therapeutic proteins and peptides (TPPs). Frontiers in pharmacology, 15, 1353626. https://doi.org/10.3389/fphar.2024.1353626
[3] Kale, A. A., & Torchilin, V. P. (2007). Design, synthesis, and characterization of pH-sensitive PEG-PE conjugates for stimuli-sensitive pharmaceutical nanocarriers: the effect of substitutes at the hydrazone linkage on the ph stability of PEG-PE conjugates. Bioconjugate chemistry, 18(2), 363–370. https://doi.org/10.1021/bc060228x
