News
Release date:2025/1/14 1:01:31

Biopharma PEG has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for our self-developed mPEG-pALD (20K) product (DMF number: 040600). 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.
Link: 
https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs

Product Information

Chemical Name: mPEG-Propionaldehyde, also known as mPEG-pALD or mPEG-CH2CH2CHO. Product Link>>>

mpeg-pald

Appearance: White or off-white powder.

Properties:

  • Reactivity: mPEG-pALD is a monofunctional PEG derivative with a reactive propionaldehyde group. Under specific conditions, this propionaldehyde group can react with amine and N-terminal of peptide and protein to form an imine bond containing a C=N double bond. This imine bond can be further reduced to form a stable secondary amine structure, making mPEG-pALD an important reagent for protein modification.
  • Mild Reaction Conditions: While the reactivity of the propionaldehyde group is lower than that of NHS esters, the reaction conditions are mild (pH range 6-9.5, with a maximum range of 5-10, and reaction time 6-24 hours). This makes it relatively easy to conjugate PEG to proteins or other materials. At lower pH levels, mPEG-pALD selectively reacts with the N-terminus of proteins, and the stability of this linkage is crucial for the preparation of immobilized enzymes.
  • High Stability: Proteins modified with mPEG-pALD not only retain their original biological activity but also exhibit significantly improved solubility and stability. This is of great significance for enhancing the efficacy and extending the half-life of biopharmaceuticals.

Applications

As an important monofunctional PEG derivative, mPEG-pALD demonstrates broad application potential in the fields of biopharmaceuticals and materials science.

1. N-Terminal PEGylation of Proteins

PEGylation with mPEG-pALD significantly enhances protein solubility, reduces immunogenicity, and prolongs circulation time in vivo. This makes it widely applicable in the development of therapeutic protein drugs, including:

  • • Biosimilars: Including recombinant protein drugs like recombinant human granulocyte-macrophage colony-stimulating factor (rhG-CSF).
  • Rare Disease Treatments: Suitable for the preparation of drugs targeting metabolic disorders and other rare diseases.

2. Nanotechnology and Advanced Material Development

mPEG-pALD is commonly used for the surface modification of nanoparticles, improving their biocompatibility. It is highly applicable in cutting-edge research areas such as drug delivery systems and gene carriers.

3. Biomedical Research

In cell culture, PEGylation technology facilitates cell adhesion control and cell surface modification. It is also suitable for ligand research, peptide synthesis, and the development of bioactive materials with functional polymers.

4. Functional Coatings and Polymer Graft Compounds

mPEG-pALD is used in the development of PEG-modified coatings and polymer graft compounds, enhancing antifouling properties and durability.

The successful filing of our Drug Master File (DMF) with the FDA demonstrates that Biopharma PEG'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.

Biopharma PEG 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@biochampeg.com if you are interested. 

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