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Our PolySarcosine based solution for biologics (Available for mAbs, recombinant vaccines, peptides, and hormones.) improves both Stability and Solubility outperforming current solutions like polysorbates without compromising safety.
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What you’ll get in the download
A concise technical overview of how PSar-based solubilizers can be leveraged to improve the formulation and delivery of biologics.
In this document, you will find:
- A description of the challenges associated with current biologic formulations, including protein aggregation, immunogenicity and limited shelf life
- An analysis of the limitations of polysorbates, including degradation in aqueous environments and PEG-related infusion reactions
- An overview of Curapath’s patented PSar solution, including linear, branched and kinked polymer architectures and the structural parameters evaluated during development
- Experimental data showing inhibition of thermally induced protein aggregation over extended periods (>92 hours)
- Solubility enhancement data at high protein concentrations (20–50 mg/mL) compared to state-of-the-art excipients
- Proof-of-concept studies with commercial and approved biologics, demonstrating improved stability without impacting binding or therapeutic activity
- In vivo toxicity data supporting a favorable safety profile following repeated intravenous administration
Resources
Frequently asked Questions
Curapath is a European Contract Development and Manufacturing Organization (CDMO) specialized in lipid- and polymer-based delivery systems. We support biotech and pharmaceutical companies from early development through GMP-ready manufacturing.
Our core expertise includes polymer and lipid excipients, lipid nanoparticles (LNPs), polymer nanoparticles (PNPs), polymer–drug conjugates, and coating polymers.
It is a patented polysarcosine (PSar)-based excipient designed to improve the stability and solubility of biologics, while maintaining a favorable safety profile.
The solution has been developed and screened across multiple polymer architectures
The PSar-based solubilizer addresses key challenges such as protein aggregation, inaccurate dosing, undesired immunogenicity and reduced shelf life caused by external stresses like temperature fluctuations, shear stress and storage conditions
Polysorbates are commonly used excipients in biologic formulations but present several limitations, including degradation over time due to ester hydrolysis, which can promote protein aggregation and negatively impact long-term stability. In addition, polysorbates contain polyethylene glycol (PEG), which has been associated with infusion-related reactions in certain patients.
Curapath’s PSar-based solubilizing agent has been developed as an alternative to polysorbates, offering improved stability and solubilization of biologics while avoiding the degradation pathways and PEG-related limitations associated with conventional surfactants.
The PSar-based solubilizing agent has been evaluated with monoclonal antibodies, recombinant vaccines, peptides and hormones, including proof-of-concept studies using approved commercial biologics
No. The document reports that the PSar excipient does not impact monoclonal antibody binding to the target or therapeutic activity, with supporting data available upon request
Yes. In vivo toxicity studies in Sprague-Dawley rats showed that repeated intravenous administration of the PSar excipient did not cause local irritation, and biochemistry and hematology profiles were comparable to saline controls
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