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PEGs
Polyethylene glycol (PEG) is a hydrophilic polymer having plenty of applications in biotechnology, nanobiotechnology, electrolytes, nanocomposites, organic–inorganic hybrid materials, biomedical applications, carbon nanotubes and drug carriers. They gained popularity in biomedicine due to their qualities of solubility and stability along with being non-toxic, biocompatible and having favorable drug delivery features and cancer diagnostics that has been approved for human use by the US Food and Drug Administration (FDA).
By employing chromatographic methods the polydisperse material can be fractionated into high purity individual oligomers. The monodisperse or single-length oligomers provide a higher level of control. This feature is essential in drug development and in the pharmaceutical industry.
Monodispersity
Industrially produced PEG is polydisperse, and it is, therefore, difficult to prepare high-purity derivatives from such material. Having a background in peptide chemistry, Erik Agner, founder of Polypure has developed a unique technology for the purification of PEG oligomers into ultrahigh monodispersity. The invented system is a complex functional process enabling the fractionation polymer blend of molecules of small differentiations into single oligomer species
Polypure considers PEGs from an organic chemistry perspective. As a result, from a chemical point of view PEGs are treated as single-length molecules with defined structure and functionality. While physically they still exhibit properties typical for polymeric materials.
The IUPAC definition for monodisperse, or uniform, polymers is that the material is composed of molecules with the same mass. Polypure uses this definition since any irregularities from products are removed during a thorough fractionation process. The use of the Polydispersity Index (PDI) has therefore a limited value when considering a nearly homogeneous population of polymeric molecules. Oligomer purity of >99% is a clear reference that is more easily understandable than a PDI equal to 1.0003.
Chromatographic technology is also used to purify intermediates and products to a high-quality level. Equipped with multiple HPLC-MS systems, the purity and performance are monitored throughout each step of the process.
Scaling
Production output at Polypure has increased to several hundred kilograms annually. The last couple of years we have significantly increased efficiency and added capacity as demand grows for high performance PEG materials. Scale-up has been in collaboration with our customers to reliably meet their needs for unique high value PEG derivatives. Having successfully boosted production volume and expanded product variety, we have developed the know-how and capacity to serve more clients with unique offerings.
Benefits & Application of Monodispersity
There are several benefits from operating with highly purified PEG for advanced applications. The fact that the oligomers have slightly different properties (e.g. retention times & molecular weights) is crucial for their use as marker and tracer molecules. Further, the unique retention times and MWs of monodisperse PEGs allow for fast and easy analytical methods in tracking the progress of a reaction.
By using HPLC-MS, Polypure obtains rapid and easily interpretable results. These analytical techniques provide valuable insights into the behavior and transformations of single oligomer reactants. The ability to accurately measure and analyze the presence and concentration of specific monodisperse PEGs allows for precise control and optimization of reactions, facilitating efficient process development and product characterization.
In many chemical processes, the generation of impurities is common, necessitating purification steps for intermediates and final products. However, the presence of polydisperse materials can further complicate these processes, making it challenging to distinguish products from reactants. For instance, when attempting to monitor PEG 1500 using techniques like HPLC-MS, the analysis becomes difficult to interpret. The broad distribution of molecular weights and retention times in polydisperse PEGs hinders clear identification and tracking of specific components.
Therefore, the high purity of monodisperse PEGs ensures that there are minimal impurities or contaminants that could interfere with experimental outcomes or compromise the desired properties of the final product. This purity is crucial in applications where consistency and reliability are paramount, such as in medical application, where precise dosing and predictable performance are critical factors.
By employing monodisperse PEGs, it enables a deeper understanding of reaction dynamics and achieve greater efficiency in purification and analysis. The distinct nature of monodisperse PEG derivatives allows for easier tracing, quality control and optimization throughout the chemical process. This not only ensures the production of high-quality final products but also streamlines research and development activities by reducing the complexities associated with polydisperse materials. Ultimately, the use of monodisperse PEGs contributes to more precise and reliable outcomes in chemical processes.