About Polypure
Polypure is a research-intensive production company specializing in R&D and manufacturing of uniform polyethylene glycol derivatives. Founded in 1999, Polypure has been supplying PEG derivatives for the pharma market, throughout early research stages, clinical trials, and in the drugs available on the market already since 2002.
Based in Norway, we design our products with a major focus on delivering the highest quality and uncompromised purity. As industry pioneers, our portfolio and unique technology make us an attractive partner for collaborative research projects.
Research is the backbone of Polypure. It is through our commitment to exploration and innovation that we are able to spearhead projects that push the boundaries of therapeutics and adapt to the ever-changing dynamics of the pharmaceutical market. We take pride in designing products that not only meet but exceed quality standards. This dedication makes Polypure a trusted choice for those who seek the highest quality in their endeavors.
Moreover, our active involvement in EU-funded projects reflects our commitment to contributing to research in medicine and uncovering novel substances for the medical industry.
The Uniformity Principle
PEG produced industrially is polydisperse, making it challenging in the production of highly pure derivatives. Polypure has 25 years of experience in pioneered techniques for synthesizing and purifying PEGs to achieve a defined chain length, known as monodisperse, uniform, or single-length PEGs. Polypure considers PEGs from an organic chemistry perspective. As a result, 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 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.
These high-quality PEGs enhance reproducibility, provide a comprehensive understanding of reaction dynamics, and significantly improve the efficiency of product purification and analysis. Polypure’s PEG derivatives streamline quality control, making it easier to monitor and optimize chemical processes.
Why PEGs?
Polyethylene glycols (PEG) are hydrophilic molecules having plenty of applications in biotechnology, nanobiotechnology, electrolytes, nanocomposites, organic–inorganic hybrid materials, biomedical applications, carbon nanotubes and drug carriers. Because of their high stability and non-toxicity, PEG components have gained popularity in biomedicine and earned approval for human use by the US Food and Drug Administration (FDA) due to their favorable attributes in drug delivery and cancer diagnostics. Additionally, there are huge advantages of monodispersity that provide a higher level of controllability and traceability which is an essential part of the pharma industry and drug development.
Technology
Erik Agner, the founder of Polypure with a background in peptide chemistry, has developed chromatographic methods to achieve ultrahigh purity in PEG oligomers. This unique system involves a purification technology that effectively separates polymer mixtures into individual oligomer species.
Chromatographic technology plays a crucial role in purifying intermediates and products to achieve high-quality products. With the aid of HPLC-MS systems, purity and performance are meticulously monitored at every step of the production process.
Polypure’s pilot production plant consists of 6 reactors and more than 20 purification systems, supported by multiple laboratories dedicated to ongoing R&D efforts. The purification process prioritizes environmentally friendly solvents and incorporates recycling and reusing loops at each production stage.
Other applications
The purification technology was initially developed for peptides, proteins and oligonucleotides. However, it is equally beneficial for the purification of other polymers such as polypropylene glycol (PPG). We are currently establishing a process for purifying PPG oligomers to >98% purity from commercially available raw materials. This allows us to investigate the true properties of the polymer and simplifies the modification of the oligomers to versatile derivatives. The combination of PEG and PPG as block polymers is widely recognized and we are actively engaged in the targeted development of functional copolymers
