When peptides for pharmaceutical or cosmetic use are being manufactured, it is essential to ensure both the quality and consistency of any raw material used during the process.

Purolite is now proud to offer PuroSynth™, an industrial product line that encompasses a wide range of polymer resin supports for the development and large-scale manufacture of peptide APIs.

PuroSynth™ supports for Solid Phase Peptide Synthesis (SPPS) are made of polystyrene with 1% DVB. They are characterized by uniform particle size distribution, high swelling and excellent performances in peptide synthesis.

WHY ANOTHER SUPPLIER ON THE MARKET?

Purolite has invested significant resources in developing a complete line of resins for Solid Phase Peptide Synthesis (SPPS) by drawing on decades of experience in manufacturing specialty polymers, and APIs in its FDA audited plant.  PuroSynth™ fills the gap in the market for reliable, industrial and high-quality resins for SPPS.

PuroSynth™ resins are designed to meet the needs of the modern, highly regulated industry - offering the customer a complete package in terms of:

•    Quality and consistency - Regulatory Support Files (RSF) are available for each product;

•    Production capabilities - (+500Kg per batch) in the EU in an ISO 9001:2008 and ISO 18001:2007 certified facility;


 

•    Efficient manufacturing process by ‘jetting’ with a very narrow particle size (no screening or fines, cost savings, greener process);

•    Fine-tuned loading with 6 different loading ranges available, that allow precise dosing of raw materials during the manufacture of peptides;

•    Purity with controlled residual organics in the resins, leading to
higher quality of final peptide;

•    Green process - avoiding harsh chemicals during the manufacture of the resins;

•    Performances in the manufacture of peptides.

 

Figure 1. PuroSynth™ – Product Line

Table 1. General Features of PuroSynth™
The uniformity 
coefficient is defined as: UC = d60/ d10. This coefficient measures the “width” of the distribution and is refl ected in the width of the Gaussian bell curve. If all beads had the same size, it would be equal to 1.0

PARTICLE SIZE DISTRIBUTION

One of the key features of PuroSynth™ products is the narrow particle size distribution due to ‘Jetting’ - the Purolite patented manufacturing process.  Jetting produces uniform sized beads, with low uniformity coefficient and high productivity in a continuous mode, allowing the production of large batches (500+ kg) in a very short time and no need for screening.  This enables a more economic, environmentally friendly (reduced waste) and controlled process than classic batch emulsion polymerisation, and in addition offers great advantages in terms of uniform kinetics and swelling during peptide synthesis, and therefore better purity of the final peptide.

The result of this ‘jetting’ process is a narrow gaussian distribution (see blue line in Figure 2) of uniform spherical beads compared to the standard suspension polymerization (see green line in Figure 2). Figure 3 shows an electron microscopy picture for PuroSynth™ products.

 

Figure 2. Particle size distribution in a typical batch obtained by suspension polymerization (green line) and in a ‘jetted’ batch with no screening (blue line)

Figure 3. Electron microscopy images for PuroSynth™ Wang/S.

PUROSYNTH™ - APPLICATIONS

PuroSynth™ resins have been tested in peptide synthesis
by Prof. Fernando Albericio in the University of KwaZulu-Natal, School of Chemistry, Durban (South Africa) and in the University of Barcelona, Department of Organic Chemistry, Barcelona (Spain).  Performances have been evaluated in terms of the purity of the final product and recovery.


 

Results show that PuroSynth™ resins are efficient in the synthesis of peptides ranging from 5 mer up to 28 mer.  Figures 4a and 4b show an example of a 10 mer peptide made using PuroSynth™ AM/S, and a competitor AM resin both functionalised with Rink Amide linker.

Figure 4. Synthesis of 10 mer peptide (ACP (65-74), MW 1063) on PuroSynth™ AM/S (a) and comparison with competitor AM resin (b) both functionalised with Rink Amide linker. Purity of final peptide: 100%

a)     Synthesis of 10-mer peptide on PuroSynth™ AM/S
b)     Comparison with competitor AM resin

References

1.    O. Al Musaimi, Y. E. Jad, A. Kumar, J. M. Collins, A. Basso, B. G. de la Torre, F. Albericio, “Investigating green ethers for the precipitation of peptides after global deprotection in solid-phase peptide synthesis”, Current Opinion in Green and Sustainable Chemistry 2018, 11:99–103.

 

2.    B. G. de La Torre, A. Kumar, Y. E. Jad, J. Collins, S. Serban,
O. Al Musaimi, G. A. Acosta, F. Albericio, “Solid-Phase Peptide Synthesis: the Greener, the Better”, Poster at 35th EPS in Dublin, 2018.